bl~7 ~35 [2 .IlV.s. BIBuarm I ~IERDIE EKSEMPlAAR MAG ONDER ..,EEN OMST ANDIGHEDE UrT DIE University Free State _,rBLIOTEEK VERWYDER WORD NIE 1111111111111111~1I1~11~1I1~I~~I~I!I~I~~I~I]I 11111111111111111111111r- Universiteit Vrystaat EVALUATION OF THE IODINE DEFICIENCY DISORDERS CONTROL PROGRAM IN LESOTHO Masekonyela Linono Damane Sebotsa (MSc. Dietetics, UFS) f' Thesis submitted to meet the requirements for the qualification Philosophiae Doctor in the Faculty of Health Sciences, Department of Human Nutrition at the University of the Free State Promoter: Prof. A. Dannhauser Co-promoter: Dr. P.L. Jooste Bloemfontein May,2003 ~n1v.r.1teit von die OrWlJfI-Vry.toot 1l~f1FOHTt 1N . ; 1 3 FEB 2004 I . u~ "'~ il!I-!O~r-::i15ppm. These tests are not as accurate as the titration method and are not recommended where more precise quantitative measurement of the content of iodine in salt is needed, for example, for the purpose of law enforcement. They are, however, technically simple, rapid and can be performed outside the laboratory. They provide more valuable information for salt iodine quality and estimated quantity (pAMMIMIIICCIDD, 1995, p.80). However, it must be noted that they should only be used qualitatively. Pandav et al. (2000) has indicated that kits are likely to consistently overestimate the availability of iodised salt. The sensitivity of the rapid test kits was not much affected by the increase in the number of observers but specificity decreased sharply. Therefore, it was suggested that titration method should be used for monitoring the iodine content of salt at all levels from production to consumers to ensure effective salt iodisaiton program. 2.6.2 EVALUATION Evaluation is a learning and management tool (WHO, 1989, p.34; Rubin, 1995, p.15). It is an assessment of what has taken place in order to improve future work. Measuring analysis and interpreting change help people to determine how far objectives have been achieved, whether the initial assumptions about what would happen were right and to make judgments about the effectiveness, efficiency, impact and sustainability of work. Evaluation uses information gathered during regular monitoring but may need other information as well (Rubin, 1995, p.16). It often uses baseline information collected at the very beginning, against which 47 progress can be measured. It happens to set times in the life of a project. It looks at the relevance, effectiveness and impact of a project with the aim of improving an existing project or influencing future policies programs and projects. Dunn and Van Der Haar (1990, p.50) state that once the IDD control program is in operation, periodic evaluation of its biological effects is mandatory. A reasonable period for a repeat survey is three years after the introduction of the iodisation program. The evaluation measures used are surveys for clinical manifestation ofIDD with emphasis on the program and incidence of neonatal hypothyroidism in the areas receiving iodised salt (Stanbury, 1987, p.39). 2.6.3 INDICATORS USED IN MONITORING AND EVALUATING IDD CONTROL PROGRAMS The various indicators used in monitoring and evaluating IDD control programs are divided into three main groups, namely, process indicators, impact indicators and sustainability indicators. 2.6.3.1 Process indicators Process indicators are used to assess the iodine content of salt during the process of delivering iodised salt from the producer to the consumer. This process includes the determination of the salt iodine content at the production site, port of entry, point of packaging and at the wholesale, retail and household levels (WHO/UNICEF/ICCIDD, 2001). (i) Salt iodine content at the production site Monitoring salt at the point of production is the most important step in a monitoring plan (pAMMIMIIICCIDD, 1995, p.8) and is the responsibility of the salt producer and health authority (WHO/UNICEF/ICCIDD, 2001). Medium to large salt producers should be urged to hire a person specifically for internal quality assurance (pAMMIMI/ICCIDD, 1995, p.8). If a batch of salt is not adequately iodised at production level, it should be re-iodised prior to distribution. 48 Government food inspectors or health inspectors should carry out periodic visits to salt production facilities to check on the in-house quality control mechanisms. They should also collect samples for titration (WHOIUNICEFfICCIDD, 2001). All brands which have been approved as properly iodised by external inspection could be allowed to use a "seal" or "logo" documenting that the salt is of good quality and meets the approval of the National Bureau of Standards, or some other regulatory commission, which has the authority and is respected by consumers (pAMMIMIIICCIDD, 1995, p.8). In collaboration with the producers, the government should develop requirements that spell out the steps to be taken in the event that standards are not met. Guidelines should specify exactly what authority has been granted to the inspectors from the government agency responsible for external quality. Reference should be made to regulations and enforcement procedures that may be called into play to ensure timely corrective measures, and this might include fines, loss of tax incentives, loss of license or other penalties. (ii) Salt iodine content at port of entry and at the point of packaging Large producers should certify that the salt, which they produce is iodised within a specified range (WHOIUNICEFfICCIDD, 2001). Such producers should seek certification by the International Organisation for Standardisation as an added guarantee that their salt is satisfactorily iodised. At the actual point of entry, customs officers can realistically be expected to check documentation on large consignments of salt, and visibly inspect all imports to check that the salt is suitably packed and labeled. Each consignment should be tested with a rapid test kit and suspect salt should be held at the border. In countries where salt is repacked into small packets (500g, 1 or 2kg), samples from each consignment should be collected for titration to ensure that the salt is adequately iodised. This can be done by the body responsible for control of IDD in the country, which is usually coordinated by the Ministry of Health (Dunn & Van der Haar, 1990, p.23). 49 (iii) Salt iodine content at wholesale and retail levels The major wholesale distributors should be informed of any legislation or regulations concerning iodised salt and should be provided with rapid test kits to check for the presence and concentration of iodine in salt before it is released for retail sale (PAMMIMIIICCIDD, 1995, p.8). If there are deficiencies noted at the wholesale level, the factories supplying the wholesalers should be notified to take necessary corrective action. At retail level, salt on sale should be tested with rapid test kits and collected for titration (WHOIUNICEF/ICCIDD, 2001). The monitoring of retail shops may be useful for identifying villages with inadequate supplies of iodised salt (PAMMIMIIICCIDD, 1995, p.8) and should be periodically undertaken by the Health Inspectors. (iv) Salt iodine content at household level When production monitoring reveals that adequately iodised salt is being produced in sufficient quantities, it will be essential to ascertain whether the product is reaching households with enough iodine in it (pAMMIMIIICCIDD, 1995, p.8). There are essentially two methods and purposes for monitoring household salt: • "Coverage surveys are used to determine the proportion of households with adequately iodised salt; these surveys are most often performed at the provincial or national levels. • Ongoing process monitoring is used to identify high-risk communities, where too few households have adequately iodised salt; this monitoring is most often done at the district level to obtain information on individual villages." Salt monitoring, using test kits, should be carried out by environmental health workers, village or community health workers or others (WHOIUNICEF/ICCIDD, 2001). Salt samples should be collected at the household level during periodic surveys to evaluate coverage. 50 2.6.3.2 Impact indicators Once a salt iodisation program has been initiated, the principal impact indicator recommended involves urinary iodine levels (WHOIUNICEF/ICCIDD, 2001). Goitre assessment, by palpation or by ultrasound, should remain a component of surveys to establish the baseline severity of IDD. Neonatal TSH levels may also playa role here if a country already has in place a screening program for neonatal hypothyroidism. These indicators are used to assess baseline IDD status and to monitor and evaluate the impact of salt iodisation on the target population. (i) Urinary iodine concentration Most of the body's iodine is excreted in the urine, usually over 90 percent, thus the iodine level in urine reflects the subject's intake (WHOIUNICEFIWHO, 1994; May & May, 1998). Urine is easy to obtain in the field, in contrast to serum specimens. Iodine in urine is stable and can withstand collection and transport under field conditions. Finally, measurement of urinary iodine has usually been technically simpler and cheaper than other biochemical markers, such as serum level of thyroid hormones or TSH, or procedures with radioiodine. Therefore, programs of iodine supplementation rely on urinary iodine concentration as the primary indicator of effectiveness (Sullivan et aI., 2000, p.2). Urinary iodine excretion can vary in individuals from day to day and even within a given day (WHOIUNICEF/ICCIDD, 2001). However, this variation tends to even out among populations. Experience has shown that the iodine concentration in early morning urine specimens (casual urine samples) provides an adequate assessment of a population's iodine status, provided a sufficient number of specimens are collected. Although twenty-four hour urine collection accurately determines the amount of iodine excreted, samples are difficult to obtain and are not necessary. Urinary iodine values from populations are not normally distributed, so it is recommended that the median value be used for interpretation of the data and not the mean (WHOIUNICEF/ICCIDD, 1994; May & May, 1998). 51 m.V.I. 1lllIIoro. Two general approaches have been used to relate the iodine content of a casual urine sample to the 24-hour value (Dunn & Van Der Haar, 1990, p.1S). One approach relates urinary iodine to urinary creatinine, a chemical substance, which the body excretes daily in fairly constant amounts. The other approach is simply to measure the concentration of iodine in the urine as ug iodine per litre of urine. Relating urinary iodine to creatinine is cumbersome, expensive and unnecessary (WHO/UNICEFIICCIDD, 2001). It has also been found to be misleading, especially for individuals who consume very little protein. Therefore it has been found preferable to express results as concentration of iodine in urine (WHO/UNICEFIICCIDD, 1994). Many different unnary iodine methods are available, ranging from technically sophisticated/automated techniques, to simple manual techniques with limited instrumentation requirements (May & May, 1998). For public health purposes, especially in developing countries, there is a need for relatively quick, simple and cost-effective methods for determining urinary iodine concentrations in reasonable numbers of samples (May et al., 1997; Rendl et al., 1998; Gnat et al., 2003). Various techniques have been compared and each has its own advantages and limitations (pino et al., 1996). The main methods used are still based on the reduction of eerie ammonium sulphate using arsenic-containing acids and timed readings in a calorimeter (May et al., 1997). The Sandell-Kolthoff reaction with some prior step involving ashing or digestion is usually the most practical approach for laboratory determination of urinary iodine (Dunn et al., 1993, p.23; May & May, 1998). The recommended methods are able to detect urinary iodine levels as low as Sug/I to 20llg!l with a coefficient of variation under 10 percent (WHO, 1994; Pardede et al., 1998). However, laboratory techniques require thorough training and standardisation. A median urinary iodine level of between lOëug/l and 200llgli in a population, indicates adequate iodine intake and optimal iodine nutrition (WHO/UNICEFIICCIDD, 2001). (ii) Thyroid size The size of the thyroid gland changes inversely in response to alterations in iodine intake, with a lag interval that varies from a few months to several years, depending on many factors (WHO/UNICEFIICCIDD,2001). These include the severity and duration of iodine deficiency, 52 the type and effectiveness of iodine supplementation, age, sex and possible additional goitrogenic factors. The traditional method for determining thyroid size is inspection and palpation. Ultrasonography provides a more precise and objective method for determination of thyroid size. (a) Inspection and Palpation Inspection depends on the visual examination of the thyroid (Demaeyer et al., 1979, p.74). It is recommended that a thyroid gland be classified as positive for goitre only when it is 4 to 5 times larger than the normal size when the neck is in the normal position. When the neck is short or the muscles are well developed, inspection alone may fail to reveal a gland that is already 4 to 5 times enlarged. On the other hand, in persons with very thin necks the lobes of the gland can be readily seen and may give the impression of a visible goitre even though the thyroid is not 4 to 5 times its normal size. Nodular glands that would be unnoticed on visual examination of the neck are frequently discovered by palpation. During palpation, children and adults are examined while standing with the head and neck first in a vertical position and then in an extended position (Demaeyer et aI., 1979, p.76). A thyroid gland whose lateral lobes have a volume greater than the terminal phalanx of the thumb of the person being examined, has been considered goitrous (Demaeyer et al., 1979, p.76; Braverman & Utiger, 2000). This definition of goitre is empirical but has been used in most epidemiological studies of endemic goitre and is still recommended (WHO/UNICEF/ICCIDD, 2001). In 1994, the WHO simplified goitre classification by reducing the number of goitre grades from five to three where all palpable thyroids are regarded as grade 1 goitres (peterson et aI., 2000) as shown in Table 5. The new criterion meant that smaller thyroids than before were regarded as goitres. This change resulted in an extra 25 percent of children being classified as goitrous in a study conducted in Tanzania. Palpation can be easily applied in the field and requires no specialized equipment. In addition, the examiners need not be medical professionals, but they should be trained and initially supervised by other examiners with experience to ensure uniformity of results (Dunn & Van 53 Der Haar, 1990, p.14). lts major disadvantage is its unreliability. Specificity and sensitivity of palpation are low especially in grades 0 and 1 due to high intra-observer variation (WHO, 1997; WHOIUNICEF/ICCIDD, 2001). However, it gives valuable information on iodine deficiency where ultrasonography is not available (Vitti et aI., 1994). Table 5. WHO thyroid size classification system of 1960 and 1994 (peterson, 2000). Thyroid size Classification grades WHO 1960 WHO 1994 Not palpable 0 0 Palpable lobes smaller than or equal to terminal 0 1 phalanges of individual's thumbs Palpable lobes larger than terminal phalanges of lA 1 individual's thumbs Visible with neck extended IB 1 Visible with head in normal position 2 2 Visible at a distance 3 2 It is recommended that a total goitre rate (grade 1 and 2 goitres) of 5 percent or more in school children aged 6 to 12 years of age be used to signal the presence of a public health problem (WHOIUNICEF/ICCIDD,2001). The cut-off point of5 percent allows both for some margin of error of goitre assessment and for goitre that may occur in iodine-replete populations due to other causes, such as goitrogen and autoimmune thyroid diseases. (b) Thyroid size by ultrasonography Ultrasonographic estimation of thyroid size has been advocated as being more precise than palpation (WHO, 1997; WHOIUNICEF/ICCIDD, 2001). The preliminary trials in urban control areas of North em and Central Italy indicated an inter-observer error of about 5 percent (Vitti et aI., 1994). The procedure is not invasive and can be used to measure more than 100 54 subjects a day. lts accuracy diminishes when the gland is quite large, but in such instances precise volume is not important for epidemiological purposes. The use of ultrasonography is strongly recommended to define the goitre endemia in areas of mild iodine deficiency and can be learned within a few days (Gutekunst, 1990; Vitti et al., 1994). The disadvantages of ultrasonography are a requirement for training, expensive equipment and the problem of transport from centre to survey site (Stanbury & Pinchera, 1994, p.78). Portable ultrasound equipment is relatively robust but requires electricity and it can be operated from a car battery with the aid of a transformer (WHO, 1994). Ultrasonography should be undertaken by well- trained operators who are able to perform up to 200 examinations a day (WHO, 1997). Since the interpretation of the results is to some extent subjective, it is important that operators participate in a calibration exercise with an experienced team before using this method. Correct interpretation of ultrasonography also relies on the availability of standardized reference criteria from populations whose iodine status is known to be adequate. Adequate intake refers to an average intake of greater than 15011gper person per day and median urinary iodine greater than 100 llg/l. Results of ultrasonography from a study population should be compared with normative data (WHOIUNICEF/ICCIDD,2001). No universal normative values for thyroid volume measured by ultrasonography in school children from iodine sufficient populations are presently available. However, the adjusted WHO and ICCIDD thyroid volume references for iodine replete, boys and girls aged 6 to 12 years by age and body surface area (BSA) as shown on Table 6, are currently used (Zimmermann et al., 2001). This criteria is suggested to be considered provisional until data from further validation studies becomes available. The values are slightly lower than the recommended values indicated by WHO and ICCIDD (WHO, 1997), which were found to be inappropriate for the Indonesian school age children (Djokomoeljanto et al., 2001) and in studies performed in other places, such as Malaysia (Foo et al., 1999). For example, the prevalence of goitre was 8 percent in Sumatra Plus Java and 12.5 percent in Bali, when using the Indonesian normative values for age, but when using the WHO and ICCIDD criteria, the prevalence of goitre in these two provinces was 3 percent and 13.3 percent respectively. The WHO, in collaboration with scientists from several countries, is 55 currently in the process of establishing new reference values for thyroid size of 6 to 12 year 0Id children who are iodine sufficient. (iii) Thyroid stimulating hormone (TSH) The pituitary secretes TSH in response to circulating levels of T4 (WHOIUNICEFIICCIDD, 2001). The serum TSH rises when serum T4 concentrations are low and falls when they are high, thus serum or whole blood TSH levels directly reflect the availability and adequacy of thyroid hormones (Hetzel, 1989, p.29). Elevated serum TSH in the neonate indicates insufficient supply of thyroid hormones to the developing brain and therefore constitutes the only indicator that allows prediction of possible impairment of mental development at a population level brought about by iodine deficiency (Delange, 1998). Elevated serum TSH is therefore of considerable concern because it indicates an inadequate thyroid hormone level during the crucial stage of brain development (WHO, 1994). Table 6. Median and upper limit of normal thyroid volume (ml) measured by ultrasonography in iodine-replete children aged 6-12 years (Zimmermann et al., 2001). Boys Girls P50 P97 P50 P97 Age (yrs) 6 2.3 3.8 2.1 3.6 7 2.4 4.0 2.4 4.2 8 2.6 4.3 2.8 4.9 9 2.9 4.8 3.1 5.7 10 3.2 5.5 3.6 6.5 11 3.6 6.4 4.0 7.4 12 4.0 7.4 4.5 8.3 BSA* (m2) 0.8 2.1 3.3 2.1 3.4 0.9 2.4 3.8 2.5 4.2 1.0 2.7 4.2 2.9 5.0 1.1 3.1 5.0 3.3 5.9 1.2 3.5 5.7 3.8 6.7 1.3 4.0 6.6 4.4 7.6 1.4 4.5 7.6 4.9 8.4 1.5 5.0 8.6 5.5 9.3 *Body surface area 56 Blood specimens may be obtained from pregnant women or school-age children (WHOIUNICEFIICCIDD, 1994). Further study of TSH distributions among these older subjects is needed to improve understanding of the specificity of their relationship to iodine deficiency. This is because elevation of TSH values in individuals is associated with all causes of primary hypothyroidism, including goitrogen ingestion, congenital hypothyroidism and autoimmune thyroiditis. Speculation on one of the factors involved has been done on the basis of the comparison of the iodine stores of the thyroid and of the needs ofT4 in adults and neonates (Delange, 1998). It is therefore concluded that TSH levels are an excellent indicator of hypothyroidism in neonates but their specificity in older groups is less certain (WHOIUNICEFIICCIDD, 1994). Thus reference data for TSH are available only among neonates. TSH screening in neonates has demonstrated its validity and usefulness and is largely implemented in countries with mild degrees of iodine deficiency (Delange, 1998). It is however still insufficiently available in countries with moderate and especially severe degrees of iodine deficiency, essentially because of a lack of resources and infrastructure. There are, however, some disadvantages to this approach. This method requires sophisticated laboratory backup and an organized program of sample collection (Stanbury & Pinchera, 1994, p.81). In addition, any program that involves blood samples carries the risk of unclean needles and the implied risk of hepatitis or HIVand AIDS. TSH screening is inappropriate for developing countries where health budgets are low (WHOIUNICEFIICCIDD, 2001). In such countries, mortality among children under five is high due to nutritional deficiencies and infectious diseases, and screening programs for congenital hypothyroidism are not cost effective. 2.6.3.3 Sustainability indicators These indicators are used to assess whether iodine deficiency has been successfully eliminated and to judge whether achievements can be sustained and maintained for the decades to come (WHOIUNICEFIICCIDD (2001). They involve a combination of median urinary iodine levels 57 in the target population, availability of adequately iodised salt at the household level and a set of programmatic indicators, which are regarded as evidence of sustainability. In considering whether the sustainable elimination of iodine deficiency as a public health problem has been achieved, the following WHOIUNICEFIICCIDD (2001) criteria should be met: "With regard to salt iodisation • Local production and/or importation of iodised salt in a quantity that is sufficient to satisfy the potential human demand (about 4-5kglpersonlyear). • 95% of salt for human consumptions must be iodised according to government standards for iodine content, at the production or importation levels. • The percentage of food-grade salt with iodine content of at least 15ppm, 10 a representative sample of households, must be equal to or greater than 90%. • Iodine estimation at the point of production or importation, and the wholesale and retail levels, must be determined by titration. At the household level, iodine content of salt may be determined by either titration or certified kits. With regard to the population's iodine status • The median urinary concentration should be at least 1OO~gIl with less than 20 percent of values below 50~gll. • The most recent monitoring data (national or regional) should have been collected at least once in the last two years. At least eight out of the following ten programmatic indicators are necessary: • An effective, functional national body (councilor committee) responsible to the government for the national program for the elimination of IDD. This council should 58 be multidisciplinary, involving the relevant fields of nutrition, medicine, education, the salt industry, the media and consumers, with a chairman appointed by the Minister of Health. • Evidence of political commitment of universal salt iodisation and the elimination of IDD. • Appointment of a responsible executive officer for the IDD elimination program. • Legislation or regulations on universal salt iodisation. Ideally regulations should cover both human and agricultural salt, but if the latter is not covered this does not necessarily preclude a country from being certified as IDD free. • Commitment of assessment and reassessment of progress in the elimination of IDD, with access to laboratories able to provide accurate data on salt and urinary iodine. • A program of public education and social mobilization to emphasize the importance of IDD and the consumption of iodised salt. • Regular data on salt iodine at factory, retail and household levels. • Regular laboratory data on urinary iodine in school-aged children, with appropriate sampling for higher risk areas. • Cooperation from the salt industry in maintenance of quality control. • A database for recording of results or regular monitoring procedures, particularly for salt iodine, urinary iodine and, if available, neonatal TSH, with mandatory public reporting. " These criteria provide the major indicators for progress towards the goal of elimination of IDD (Hetzel, 2000, p.636). They require adequate laboratory services so that the monitoring and independent evaluation can be carried out which are essential to ensure sustainability. They include both IDD status indicators (urinary iodine) and a control program process indicator (salt iodisation), since it is important to ensure sustained control of iodine deficiency for an entire population rather than to focus on reaching goals based on measuring the IDD status of a single group (WHOIUNICEF/ICCIDD, 1994). 59 2.7 SUSTAINABILITY OF IDD CONTROL PROGRAMS Sustainability is critical in all the programs. It is stated that IDD cannot be eradicated in one great global effort like smallpox and poliomyelitis (WHOIUNICEF/ICCIDD (2001). It is a nutritional deficiency that is primarily the result of a deficiency of iodine in soil and water and therefore it will return at any time after its elimination if control programs fail. There are three major components required to consolidate the elimination of IDD and to sustain it permanently, namely political support, administrative arrangements and an assessment and monitoring system. 2.7.1 POLITICAL SUPPORT Development of a program begins with high-level advocacy to achieve broad commitment to universal salt iodisation as a major national solution to IDD (Van Der Haar, 1997). As the program is progressing, high level advocacy merits continued attention because, at all stages, decisions about resources and priorities by the leaders of government and salt enterprises can have implications for its continued effectiveness. The governmental agency responsible for nutrition or public health should playa major role in planning and executing the program and it is important to include other relevant ministries and interested groups at an early stage in planning the program (Dunn & Van der Haar, 1990, p.23; Maberly, 1994). Political support for the elimination of IDD depends on community awareness and understanding of the problem (WHOIUNICEF/ICCIDD, 2001). Without this community awareness, politicians are unlikely either to be aware or willing to act. Information, education and communication (mC) are the most important (and most neglected) components of an IDD control program (Dunn & Van der Haar, 1990, p.4S). Many programs in the past have introduced iodine supplementation measures without educating the target group or other involved parties about the grave consequences of IDD and its non-correction. Such unexplained interventions may meet with indifference or resistance and frequently are not sustained. An aggressive campaign to make all interested parties aware of the consequences 60 and prevalence of IDD and the necessity for correction should be a cornerstone of an IDD control program. Education should occur at all levels, including the following: politicians and decision makers, health workers, workers in the salt trade, citizen groups, and the iodine deficient community. All affected parties must understand the grave consequences of iodine deficiency as well as the means for its correction. Education begins with health authorities in the country and extends to other branches of the government, health providers, industry, marketing and the affected communities (Dunn, 1996). One of the most crucial challenges in the process of eliminating IDD is raising awareness of how widespread and damaging iodine deficiency is. Although l.6 billion are at risk of IDD, most people know nothing about it and even many health care workers remain unaware of the full impact IDD has, particularly on mental development (pAMMIMIIICCIDD, 1995). For example, in India the Non- Governmental Organisations (NGOs) reported poor awareness of the causes, consequences and preventative measures associated with IDD, even among district officials (pandav et aI., 1995, p.1). In India, the proportion of respondents who considered goitre as a disease was only 34.3 percent, while 4.4 percent knew correctly the causes of goitre and only 9.8 percent knew that goitre can be prevented by iodisation of salt (Mohapatra et aI., 2001). In both countries the prevalence ofIDD was reported to be high. The public needs to know that once salt is iodised, a crucial collective step has been taken that changes the course ofa nation's development future (pAMMIMIIICCIDD, 1995, p.1). 2.7.2 ADMINISTRATIVE ARRANGEMENTS Each country is different regarding the severity and distribution of its iodine deficiency and the factors that govern the choice of treatment strategy (Dunn & Van Der Haar, 1990, p.45). Therefore, the structure and operation of the control program should be tailored to the actual conditions in a particular country. However, Hetzel (1987, p.12) has conceived a model known as the "Hetzel wheel", which identifies the key factors that are involved in a national IDD program. The national body responsible for the management of the IDD control program should operate within this process model (WHOfUNICEFIICCIDD, 2001). The success of the "Hetzel wheel" is dependent on full support from political and legislative authority to carry out 61 the program (Hetzel, 1987, p.l3). The social process involves the following six components, clockwise on the wheel (WHO/UNICEFflCCID, 2001): • "Assessment of the situation requires baseline IDD prevalence surveys, including measurement of urinary iodine levels and analysis of the salt situation. • Dissemination of findings implies communication to health professionals and the public, so that there is full understanding of the IDD problem and the potential benefits of elimination. • Development of a plan of action includes the establishment of an intersectoral task force on IDD and the formulation of a strategy document for achieving the elimination ofIDD. • Achieving political will requires intensive education and lobbying of politicians and other opinion leaders. • Implementation needs the full involvement of the salt industry. Special measures, such as negotiations for monitoring and quality control of imported iodized salt, will be required. It will also be necessary to ensure that iodized salt delivery systems reach all affected populations, including the needy population. In addition, the establishment of cooperatives for small producers, or restructuring to larger units of production, may be needed. Implementation will require training at all levels in management, salt technology, laboratory methods and communication. • Monitoring and evaluation require the establishment of an efficient system for the collection of relevant scientific data on salt iodine content and urinary iodine levels" The functions of the IDD control unit must be kept intact with an appropriate budget to ensure permanent success of the IDD control program (Dunn & Van Der Haar, 1990, p.48). IDD control costs money and United Nations (UN) agencies, such as UNICEF, United Nations Development Project (UNDP), World Bank, Kiwanis international, which are in a position to provide substantial financial support, should be approached. However, the long-range objective must be to make the IDD control unit an integral item in the national or regional governmental budget and not dependent on outside funds. The additional cost of iodine 62 fortification in the process of salt production should eventually be borne by an educated community to assist sustainability (WHOIUNICEFIICCIDD, 2001). The administrative structure should be composed of a dedicated IDD control unit (made up of representatives from various government ministries), workers in the salt trade, citizen groups and the iodine deficient community (Dunn & Van Der Haar, 1990, p.45). This multidisciplinary orientation required for a successful program, however, poses special difficulties in implementation (WHOIUNICEFIICCIDD, 2001). Particular problems often arise between health professionals and the salt industry, with their different professional orientations. Therefore there is a need for mutual education about the health and development problems of IDD, and about the problems encountered by the salt industry in the continued production of high quality iodised salt. Such teamwork is required for sustainability to be achieved. 2.7.3 ASSESSMENT AND MONITORING SYSTEM A situation analysis is the first step in planning a program (Dunn & Van Der Haar, 1990, p.25). The available information should be reviewed concentrating on the extent and severity of iodine deficiency, special factors which influence IDD and its severity, health services available for implementation of IDD control program and the possibilities for prevention of iodine deficiency. Measurement of salt and urinary iodine provides the essential elements for monitoring whether IDD is being successfully eliminated (WHOIUNICEFIICCIDD, 2001). These procedures require internal and external quality control in order to ensure reliability of the data collected. In order to be effective the surveillance system needs laboratories for measurement of salt iodine and urinary iodine and production quality assurance charts and databases for recording the results of the regular monitoring procedures, particularly for salt iodine, urinary iodine, thyroid size and, when available, neonatal TSH. 63 According to Maberly (1998), elimination of iodine deficiency requires the following: • "Developing simple, qualitative tests to verify inexpensively the level of iodine in salt, rather than only to indicate its presence or absence. • Establishing the best practices of small-scale salt iodisation and simplifying and standardizing the process with appropriate quality assurance. • Evaluating the impact of using iodised salt in food processing (such as pickling or cheese-making or in various types of cooking) to address the common perceptions of its negative qualities in such processes or inordinately high iodine losses. • Evaluating factors that have led to successful implementation of JDD programs so that these can be replicated in areas where progress is lagging or be used to model success in other nutrition or public health programs." In the planning of a survey, it is important to include other institutions and organizations in the process (Sullivan et al., 2000, p.2). All interested ministries and organizations should be involved to assure they know the survey is to be performed and to allow them to provide input into the survey design and implementation. In many countries non-governmental organizations (NGOs) play and important role in JDD elimination. 2.8 SUMMARY Iodine deficiency occurs because of its deficiency in the soils and therefore in the food and water originating from that soil. Thus people and animals eating food grown mainly in such soils are all at risk of developing JDD. JDD ranges from endemic goitre to endemic cretinism. Other effects include: mental and physical retardation, impaired school performance and work capacity, increased rates of abortion, stillbirths, congenital anomalies, perinatal, infant and child mortality. Iodine deficiency affects about 740 million people worldwide, about 150 million in Africa and is a clear public health problem in Lesotho. The available methods for JDD control are mainly through the iodisation of salt and the use of iodised oil. Other available methods include the iodisation of water, bread or sugar. Salt 64 iodisation is the standard medium and long-term strategy for control of IDD because of its availability and high consumption rate. Continuous quality control and verification of the iodine levels in salt is imperative to ensure that the action is sustained and effective. Testing with rapid test kits can be done at retail level in all districts and at all entry points of salt. Where necessary results should be checked by the titration method in a central laboratory. Legislation is required even though salt iodisation may be done voluntary by the salt industry. Ensuring adequate monitoring and evaluation is a necessary condition and one of the best guarantees of successful and sustained implementation of the IDD control program. 65 CHAPTER3:METHODOLOGY 3.1 INTRODUCTION The main objective of this study was to evaluate and monitor the salt iodisation program, which is the only current IDn intervention program in the country. The challenge as indicated by the WHOIUNICEF/ICCIDn (2001) was to apply the IDn indicators using valid and reliable methods while keeping costs to the minimum. The process, impact (outcome) and sustainability indicators were used to monitor and evaluate the salt iodisation process and to assess baseline IDn status. The indicators were also used to assess whether iodine deficiency has been successfully eliminated and to judge whether achievements can be sustained and maintained in the future. The target population in this study was primary school children and women of childbearing age. In this chapter, the study design, selection of study participants and salt samples, procedures for the collection of information, clinical examination (palpation), biochemical (for urine and salt samples) and statistical analyses will be discussed. The study was designed to include all the districts and ecological zones and the sample size was based on the WHOIUNICEF /ICCIDn (2001) recommendations. 3.2 STUDY DESIGN The study was designed as a cross-sectional survey, which was household, school, retail and entry point based (Figure 1). The outcome indicators (urinary iodine concentration, thyroid size) and process indicators (salt iodisation) were measured. These indicators were used to estimate the current IDn status, salt iodisation level and the coverage in the household use of adequately iodised salt. Furthermore, the indicators were used to assess the sustainability of the IDn control program. 66 The 10 districts and 4 ecological zones in Lesotho -, Design /IUsters~vi•llageS) -, 6 entry points Household level school level retail level entry po•int level Population per cluster 30 wo•men 30 chi•ldren 2 reta•ilers 1 Samples collected urin•e and salt u Measurements Thyroid siz•e, Thyroid••nne salt saltsize and Salt iodine Salt iodine urinary iodine urinary iodine content content concentration and concentration salt iodine content Fig. 1 Schematic outline of the study design and population size The multistage proportionate to population size (PPS) cluster sampling method was applied based on WHOIUNICEFIICCIDD (2001) recommendations. Compared to simple random sampling, in cluster sampling there is a design effect, which will widen the 95 percent confidence interval of the overall results. A total of 31 clusters (villages) were proportionally selected from the ecological zones in all ten districts of Lesotho based on the total number of households in each district and ecological zone (Table 7). All the ecological zones in each district were listed and the total number of households in each of the ecological zones in the ten districts was obtained from the 1996 population census data. The cumulative population of households was calculated. The total number of households in the whole country was divided by the number of clusters (31) and the value was used as a sampling interval. and a random number table was used to select the starting point. The clusters were assigned by adding the sampling interval cumulatively (Table 8). To select villages, all the villages in each district and ecological zones were given numbers and labeled pieces of paper put in a box. Pieces of 67 papers were mixed and randomly picked A list of the names of selected villages is given in Appendix 5. This selection was done with the aid of the Bureau of Statistics in Lesotho. 3.3 REPRESENTATIVENESS OF SAMPLE SELECTION Lesotho is divided into ten administrative districts and ecologically divided into four distinct zones, namely, Mountains, Foothills, Senqu river valley and Lowlands. The districts include parts of the four ecological zones (Appendix 2). Based on the number of households in each district and ecological zones (Table 7), 31 clusters were proportionally selected from all the districts (Table 8). Table 7: The total number ofhouseholds by ecological zones and districts (Bureau of Statistics; Population census, 1996). The number of households in each of the ecological Total number of zones in each district households DISTRICTS LI Ft Mt Srv BUTHA-BUTHE 8773 11302 1119 - 21194 LERIBE 49452 8594 4408 - 62454 BEREA 30306 7334 2921 - 40561 MASERU 50727 8812 6869 - 66408 MAFETENG 45216 5112 - - 50328 MOHALESHOEK 32688 3772 6780 4692 47932 QACHAS'NEK - - 13506 3199 16705 MOKHOTLONG - - 15045 - 15045 THABA- TSEKA - - 11995 2864 14859 QUTHING - - 8885 7760 16645 LESOTHO 215162 43936 74518 18515 352131 LI = Lowlands Ft = Foothills Mt =Mountains Srv = Senqu river valley 68 Table 8: Allocation of clusters by ecological zones and districts The number of clusters allocated by ecological Total number of clusters zones in each district DISTRICT LI Ft Mtn Srv BUTHA-BUTHE 1 - - 1 LERIBE 4 1 - - 5 BEREA 2 1 - - 3 MASERU 7 1 1 - 9 MAFETENG 4 - - - 4 MOHALESHOEK 2 - 1 - 3 QUTHING - - 1 1 2 QHACHAS'NEK - - 1 - 1 MOKHOTLONG - - 1 - 1 THABA-TSEKA - - 2 - 2 LESOTHO 19 4 7 1 31 LI = Lowlands Ft = Foothills Mt =Mountains Srv = Senqu river valley 3.4 STUDY POPULATION School going children aged 8 to 12 years and women of child bearing age (15 to 30 years) were included as the target study population. Women and children with severe diarrhoea, fever and severe protein energy malnutrition (pEM) were excluded from the study. 3.4.1 TARGET POPULATION 3.4. 1.1 Primary school chi ldren Primary school children aged 8 to12 years were selected as the target population. This group was selected because the proportion of children attending primary school in Lesotho is 89 percent (Ministry of Education 2002), which is above the recommended 50 percent (WHOIUNICEF/ICCIDD, 2001). Children aged 8 to 12 years were selected based on the fact 69 that it is more difficult to perform palpation in smaller children because their small thyroids and stage of puberty might be an additional variable In older children (WHOIUNICEFIICCIDD,2001). School-aged children are also a useful target group for IDD surveillance because of their combined high vulnerability, easy access and applicability to a variety of surveillance activities. The children were palpated and asked for urine samples. In each of the selected clusters there is one government primary school, therefore each government school in each cluster was visited. 3.4.l.2 Women of child bearing age Women of child bearing age (15-30 years) were selected based on WHOIUNICEFIICCIDD (2001) recommendations. It is stated that screening women of child bearing age provides an opportunity to establish the iodine status of a group that is particularly crucial because of the susceptibility of the developing foetus to iodine deficiency. However, after the age of 30 years, goitre rates are no longer reliable indicators of current iodine status. According to the WHO (1993) preformed nodules or goitres may have occurred in childhood or early adolescence. Furthermore, after long-standing iodine deficiency, serum TSH levels fall or become suppressed due to functional autonomy and, after iodine supplementation, TSH normalizes in only a fraction of the adult population. The women were palpated and asked for urine and salt samples. 3.4.2 EXCLUSION CRITERIA 3.4.2.1 Children and women with severe PEM Many studies indicate that severe PEM affects thyroid function and the metabolism of thyroid hormones. It also interferes with iodide uptake by the thyroid and with thyroglobulin formation (Beard et ai, 1990). The suspected children and women were weighed using the calibrated UNICEF digital scale and weights were plotted against ages using the National Centre for Health Statistics (NCHS, 1976) growth charts, and the expected weight for height was 70 determined. The clinical signs of malnutrition were observed by the nurses and then classified using the "Wellcome classification" (Table 9). Table 9. Wellcome classification (WHO, 1991). Percentage (%) Oedema present Oedema absent expected weight for age 60-80% Kwashiorkor Underweight Less than 60% Marasmic-Kwashiorkor Marasmus Children and women with severe PEM were therefore excluded from the study using the following cut off point: Severe PEM: Kwashiorkor, Marasmus or Marasmic- kwashiorkor (WHO, 1991, p.6) 3.2.2.2 Children and women with severe diarrhoea and fever Variation in urinary volume, through dehydration, increased fluid consumption or dilution has been shown to provide misleading estimates of the actual urinary iodine level (Dunn and Van Der Haar, 1990, p.15; Dunn et al., 1993). As there is variation in urinary volume in severe diarrhoea and fever, suspected women and children were assessed by the nurses and excluded from the study using the following definitions: Severe diarrhoea: Loose or watery stools more than 3 times a day within 24 hours of the study (WHO, 1992, p.13): Fever: Abnormal high temperature with sweating within 24 hours of the study (Werner, 1988, p.25). 71 3.4.3 SAMPLE SELECTION AND SIZE A total of 1860 women and children were randomly selected and palpated for thyroid size. 1860 urine samples were collected from the women and the children at various time of the day. 1226 salt samples were collected from the randomly selected women and retailers and from the entry points. One officer gave information for the questionnaire on programmatic indicators. 3.4.3.1 Sample selection In each of the 31 selected clusters, 30 women were randomly selected from the households to be palpated and to give both urine and salt samples. The centre of the village was identified and the direction of the top of the bottle that had been spun was taken. The number of the houses in the line of the direction was counted from the centre to the edge and one house was chosen at random as the starting point. The houses were given numbers, which were picked up from a tin. The household with a picked number was selected. Each household in that direction was visited. When there were no occupants in the selected household, efforts were made to search for them or to return the following day. If the age of the woman was more than 30 or less than 15 the household was not included and the field worker moved to the next household. Where there were two women aged between 15 and 30, one woman was randomly selected. To select one woman randomly in a household, one piece of paper labeled X and one not labeled were put in a tin. The two women were asked to pick a paper without looking in the tin and the woman who chose the piece of paper with an X on it was included in the study. The selected woman was palpated for thyroid size and asked for a sample of salt used in the household. The field worker mixed the salt in its container and three tablespoons were obtained. Where household salt was less than three tablespoons, the available amount was taken. The salt samples were kept in sealed zip plastic bags and labeled stickers were used for identification. The selected woman was also asked to half fill the 40ml capacity bottle with unne. The bottles were tightly closed with plastic screw-caps to prevent leakage and evaporation and were labeled for identification using stickers. Pink coloured stickers were used for pregnant women. The information on the name of the district, ecological zone and woman 72 was collected, including the identification number, age and thyroid size. This information was recorded on the household data sheet (Appendix 6). In each cluster, there is one government school. Some clusters have both private and government primary schools but only the government schools were included in the study. In each of the 31 selected clusters, 30 children were randomly selected from each school to be palpated and give urine samples. In each school random selection was done with the help of two class teachers, the children aged between 8 and 12 years were separated by gender and given numbered pieces of paper and duplicates put in two tins. The pieces of paper were mixed and 15 picked at random from each tin, and the children with the picked numbers were included in the study. In some cases the number of boys aged between 8 and 12 was less than 15, therefore, the same random sampling was used to select more girls (aged between 8 and 12 years) to arrive at 30 children. The selected children were palpated for thyroid size and asked to half fill the 40ml capacity bottle with urine. The bottles were tightly closed with plastic screw caps to prevent leakage and evaporation and labelled for identification using stickers. The information on the name of the district, ecological zone, school and child was collected, including the identification number, age, gender and thyroid size. This information was recorded on the school data sheet (Appendix 6). Two retailers in each cluster were also randomly selected and six salt samples purchased. The village chief was asked to name all the retailers in the cluster and the pieces of paper with names on them were put in a tin, mixed and two pieces drawn at random. Three 500g or alternatively lkg packets of salt samples (preferably different brands available) were purchased by the field workers from the first retailer and three samples from the second retailer, resulting in a total of six salt samples in each cluster. In the case of salt packed in 20kg bags, half a cup of salt was obtained and put into a plastic bag, which was then tightly sealed. Labeled stickers were used to identify the samples. The information regarding the name of the district, ecological zone and retailer, identification number, brand and type of salt was recorded on the retail data sheet (Appendix 6). 73 There are 13 entry points (or border posts) in the country of which 6 are commercial (goods are allowed to pass) and 7 are non-commercial (goods are not allowed to pass) (Table 10). There are no entry points in the Berea and Thabatseka districts. The people in Quthing district use Qachas'nek, Mafeteng and Maseru entry points while those in Mohaleshoek use Mafeteng and Maseru entry points for their imports. The people in Thabatseka use the Maseru entry point and those in Berea use both the Leribe and Maseru entry points. Salt samples were purchased by the field workers at all the commercial entry points (Table 7 & Appendix 5). At each entry point 10 salt samples were purchased, except for Maseru and Maputsoe where 50 and 20 samples were obtained respectively. This was based on the high rate of goods entering the country from these two entry points. 500g or alternatively lkg packets of different brands of salt were randomly obtained from each wholesaler or retailer at all the commercial entry points of Lesotho. Two salt samples (preferably different brands) were purchased from the first vehicle at the entry point then two from the next one until enough samples were collected. In the case of salt packed in 20kg bags, the bag was opened and half a cup of salt taken and put in a plastic bag, which was then tightly sealed. Labeled stickers were used for identification. The information on the name of entry point, identification number, brand name and type of salt was recorded on the entry point data sheet (Appendix 6). 74 Table 10. The entry points of Lesotho Districts Border post/entry point Type Number of salt samples collected Maseru Maseru bridge Commercial 50 Leribe Maputsoe Commercial 20 Gum tree Non-commercial - Buthabuthe Caledon Non-commercial - Monontsa Commercial 10 Mokhotlong Sani-top Commercial 10 Quthing Tele Non-commercial - Dill i-Dilli Non-commercial - Qachas'nek Ramatseliso Non-commercial - Qachasnek Commercial 10 Mafeteng Vanrooyen Commercial 10 Sephapho Non-commercial - Mohaleshoek Makhaleng Non-commercial - 3.4.3.2 Sample size Sample size was based on the WHOIUNICEF/ICCIDD (2001) recommendations, which states that selection of at least 30 samples of both urine and salt per cluster permits the investigation of differences among clusters and gives an indication of localities where iodine deficiency may still be a public health problem. It is recommended that more children or women be palpated for thyroid size. 30 women and 30 children were selected based on the fact that as an evaluation study, the results on palpation would be used to estimate IDD in order to follow trends. These results on palpation would therefore not be used as a reflection of the current iodine intake. The total sample size collected was as follows: 75 (i) Salt samples A total of 1226 salt samples were collected in the whole country. 930 (30 households X 31 clusters) were collected at household level, 186 (6 salt samples X 31 clusters) at retail level and 110 at entry points. (ii) Urine samples A total of 1860 urine samples were collected from randomly selected women of child bearing age and primary school children. 930 (30 children X 31 clusters) urine samples were obtained from primary school children and 930 (30 women X 31 clusters) from women of childbearing age. (iii) Thyroid size palpations 1860 women and children were palpated for thyroid size. 930 (30 children X 31 clusters) children aged 8 to 12 years and 930 (30 women X 31 clusters) women aged 15 to 30 were randomly selected and palpated for thyroid size. (iv) Questionnaire on programmatic indicators A questionnaire on programmatic indicators (Appendix 7) was administered to one member of the IDD control task force. This member is the chairperson of the IDD control task force and the director of the Food and Nutrition Coordinating Office (FNCO), which coordinates all the nutrition activities in the country. The questionnaire was adapted from the programmatic indicators for sustainable elimination of IDD listed in the WHOIUNICEFIICCIDD (2001) report. 76 3.5 MEASUREMENTS AND TECHNIQUES The variables measured in this study were the iodine content of salt and coverage in the use of adequately iodised salt at household level (process indicators). The urinary iodine concentration, thyroid size and the prevalence of goitre (impact/outcome indicators) and sustainability of the IDD elimination program (sustainability indicator) were also measured. Reliability and validity as defined below were very important in this study and were ensured based on international recommendations. Reliability is the degree to which a test consistently measures whatever it measures (Gay, 1996, p.32). The more reliable a test is the more confidence it gives that the results obtained from the administration of the test are essentially the same results that would be obtained if the test were re-administered. According to Katzenenellenbogen et al. (1999, p.90) variations between measures can be reduced by: • Standardization and calibration of the instrument. The quality of the instrument or questionnaire must be improved. • Setting exact ways of measuring (standardization of measurement or interview). • Intensive training periods for all observers and interviewers. • Supervision and periodic checks on their work. • Selection of observers and interviewers along similar criteria with reference to age, sex educational level and other relevant characteristics. • Repeated measures, which make it possible to assess and adjust for biological variation. Validity is the degree to which a test measures what it is supposed to measure and consequently permits appropriate interpretation of results (Gay, 1996, p.35). The basic model for validation involves the comparison of a test method against a reference measure of known validity (Margetts & Nelson, 2000, p.16). 77 3.5.1 THE IODINE CONTENT OF SALT The iodine content of salt refers to the iodine content of salt at entry points, at retail level and at household level in different districts, ecological zone and at national level, and of different brands and types available in the country, expressed in parts per million (ppm). 3.5.1.1 Cut-off point A concentration between 40 and 60 ppm is the recommended iodisation level of salt entering the country according to the universal salt iodisation legislation in Lesotho (Appendix 3). 3.5.1.2 Techniques to determine the iodine content of salt It was important that valid results were obtained in the present study because it will serve as the evaluation and monitoring tool of the country. Therefore, the iodometric titration method was selected for chemical analysis of salt samples at the Medical Research Council (Cape Town). There are a number of methods for testing the iodine content of salt, ranging from qualitative spot tests, which are useful in field settings, to more quantitative methods such as iodometric titrations (pAMMIMIIICCIDD, 1995, p.86). The iodometric titration method was selected based on the fact that it has been stated that if salt iodine test data is to be used for iodine deficiency program evaluation and monitoring, it is important that the results are reliable, accurate and timely ((PAMMIMIIICCIDD, 1995, p.86; Sullivan et aI., 2000, p.2). Furthermore, PAMMIMIIICCIDD (1995, p.86) state that the iodometric titrations are performed in Laboratories for validation purposes. The reaction mechanism of the iodometric titration method includes liberation of free iodine from salt and titration of the free iodine with thiosulfate (WHOIUNICEFIICCIDD, 2001). Following the method ofMannar and Dunn (1995) and PAMMIMIIICCIDD (1995), 109 of salt was dissolved in distilled water and made up in 50ml portions (Appendix 8). l ml of 2N sulphuric acid and 5ml, of 10percent KI was added. The liberated iodine was titrated with sodium thiosulfate solution using Irnl of 1 percent starch indicator near the end of titration. 78 The level of thiosulfate in the burette was recorded and converted to parts per million using the conversion table. 3.5.2 COVERAGE OF THE HOUSEHOLD USE OF ADEQUATETL Y IODISED SALT Coverage in the household use of adequately iodised salt refers to the percentage of households using salt that is adequately iodised according to WHO/UNICEF/ICCIDD (2001) criteria. 3.5.2.1 Cut-off point At household level, salt is adequately iodised when the iodine content of salt is greater than 15ppm according to the WHO/UNICEF/ICCIDD (2001). 3.5.2.2 Techniques to determine the coverage in the household use of adequately iodised salt. The results obtained from analysing the iodine content of salt (section 3.5.2.2) were used. The percentage of households using adequately iodised salt (salt iodised at greater than 15ppm) was calculated to obtain coverage in household use of adequately iodised salt. 3.5.2.3 Reliability and validity in collection and analysis of salt samples (a) Reliability • Data collectors who had been trained collected the samples using the data collection guide (Appendix 9). • The stability of iodine in salt is influenced by the moisture of salt, ambient temperature, humidity and sunlight exposure (Stewart et al., 1996). Salt samples were therefore collected in the zipped plastic bags and kept away from direct sunlight by trained field workers. • Samples were collected, labeled correctly and packed after each field visit. 79 • The nutritionists supervised the work of the other field workers during field visits to ensure that salt samples were collected in accordance with the data collection guide. • The researcher regularly visited the teams for general supervision of salt sample collection. Each team was visited twice during the fieldwork. During these visits the researcher spent 2 days with the team, and went to the households, retailers and entry point. • The samples were checked by the supervisor after each field visit and were rechecked by the researcher on arrival from the district. She saw to it that they were correctly, labeled, tightly closed and stored in batches in the boxes ready to be transported to Cape Town for analysis. • The Coefficient of variation for the analysis of iodine in salt by the iodometric titration method in the laboratory at the Medical Research Council was 2.7 at a concentration of 50ppm. With standard solutions of KI03 at concentrations of 25ppm and 70ppm, the coefficient of variation was l.O. The operation sensitivity, that is, the lowest concentration detectable in standard solutions, was 1ppm and the coefficient of variation was 6.5 at this level. (b) Validity • In the absence of external gold standards such as neutron activation analysis, the iodometric titration method for evaluation and monitoring IDD status is recommended internationally (WHOIUNICEFIICCIDD, 2001). 80 3.5.3 URINARY IODINE CONCENTRATION Urinary iodine concentration refers to the iodine content of the urme of primary school children (8-12 years) and women of childbearing age (15-30 years) expressed in micrograms per litre (ug/l). 3.5.3.1 Cut-off point The WHOIUNICEFIICCIDD (2001) epidemiological criteria for assessing severity of IDD based on median urinary iodine levels were used (Table 11). Table 11. The epidemiological criteria for assessing iodine nutrition based on median urinary iodine concentrations in school-aged children (WHOIUNICE/ICCIDD (2001). Median value (ug/I) Iodine intake Iodine nutrition <20 Insufficient Severe iodine deficiency 20-49 Insufficient Moderate iodine deficiency 50-99 Insufficient Mild iodine deficiency 100-199 Adequate Optimal 200-299 More than adequate Risk ofIIH within 5-10 years following introduction of iodised salt to susceptible groups >300 Excessive Risk of adverse health consequences (HH, autoimmune thyroid diseases) 3.5.3.2 Techniques in determining the urinary iodine concentration The method using Ammonium persulfate was used at the Medical Research Council (Cape Town) for measurement of urinary iodine concentration. The procedures followed were as described by Sullivan et al. (2000) (Appendix 10). The principle of the method is that urine is digested with Ammonium persulfate to cerous form and is detected by the rate of colour 81 disappearance, which is the Sandell-Kolthoff reaction (WHOIUNICEFIICCIDD, 2001). This method was selected in the present study based on the fact that it is an internationally recommended method, which offers a number of advantages, especially for laboratories in developing countries where resource limitations often exist (Sullivan et al., 2000, p.36). The advantages include the following: • Safe digestion process (Ammonium persulfate is the digestion medium). • Simple manual method. • Avoids expensive or sophisticated instrumentation. • Reagents can be made in the laboratory, so the method is not reliant on diagnostic suppliers. • Good performance characteristics. • Cost effective and sustainable. 3.5.3.3 Reliability and validity (a) Reliability • Data collectors who had been trained collected the samples using the data collection guide (Appendix 9). • 40ml capacity bottles with screw tops were used to prevent leakage and approximately 20ml urine samples were collected based on May and May's 1998 recommendations for adequate samples. • Iodine in urine is very stable (May & May 1998). Urine samples were however, kept cool until analysed to prevent smell and mould growth by being transported in cooler bags and stored in refrigerators. • The nutritionists supervised the work of the other field workers during field visits to ensure that urine samples were collected in accordance with the data collection guide. 82 • The researcher also regularly visited the teams to supervise urine sample collection. The researcher regularly visited the teams for general supervision. Each team was visited twice during the fieldwork. During this visits the researcher spent 2 days with the team, and went to the households and schools. • The bottles containing urine samples were labeled with a permanent marker. • The supervisor checked all samples after each field visit and these were rechecked by the researcher on arrival from the district to ensure that they were correctly labeled, tightly closed and were then stored in batches in the refrigerator at the central laboratory ready to be transported to Cape Town for analysis. • The coefficient of variation of urinary iodine analysis for the method using Ammonium persulfate in the laboratory at the Medical Research Council is 7.7 percent at a concentration of 10flgll. (b) Validity • The chemical analysis in this study using ammonium persulfate is the recommended method of urinary iodine analysis (WHOIUNICEF/ICCIDD, 2001). • The Medical Research Council laboratory has successfully participated for a number of years in international quality control exercises for the determination of urinary iodine concentration. The urinary iodine analysis done in this laboratory compared very well with the mass spectrophotometric methodology used in the international quality control program run by the Centres for Disease Control and Prevention (Atlanta, USA). 83 3.5.4 THYROID SIZE Thyroid size refers to the thyroid size of children (8-12 years) and women of child bearing age (15-30 years) determined by palpation, where the thyroid gland is considered goitrous when each lateral lobe has a volume greater than the terminal phalanx of the thumbs of the subject being examined. 3.5.4.1 Cut-off point The WHOIUNICEF /ICCIDD (2001) criteria for classifying the size of the thyroid were used (Table 12). Table 12. Simplified classification of goitre by palpation (WHOIUNICEF/ICCIDD (2001). Grade 0 No palpable or visible goitre Grade 1 A goitre that is palpable but not visible when the neck is in the normal Position, (i.e., the thyroid is not visibly enlarged). Thyroid nodules in a Thyroid, which is otherwise not enlarged, fall into this category. Grade 2 A swelling in the neck that is clearly visible when the neck is in a normal position and is consistent with an enlarged thyroid when the neck is palpated. 3.5.4.2 Techniques in the determination of thyroid size Inspection and palpation, which are the traditional methods used to determine thyroid volume were used to assess the thyroid size of the children and women. In areas of moderate to severe iodine deficiency, inter-observer variations in performing this assessment are usually low. However in areas of mild endemicity, and generally when goitres are very small, inter-observer variations can be as high as 40 percent (WHOIUNICEF/ICCIDD, 1994). For this reason the use of ultrasonography has been recommended. Ultrasonography is a safe, noninvasive 84 technique that provides a more precise and objective method of determining thyroid volume than inspection and palpation. However, such examinations are cumbersome and costly to carry out in remote parts of low-income countries (Peterson, 2000). Ultrasonography has never been used and is not available in Lesotho. Therefore, in the absence of ultrasonography, inspection and palpation were used because this gives valuable information on iodine deficiency where ultrasonography is not available (Vitti et aI., 1994). The thyroid size of the randomly selected primary school children and women of childbearing age was determined using the standardised procedure for palpation (Appendix 11). A woman or child to be examined was asked to stand in front of the nutritionist who looked carefully at the neck for signs of visible thyroid enlargement. The nutritionist then stood behind the subject whose neck was in the neutral position and the thyroid was palpated by gently sliding the fingers along the side of the trachea (wind pipe) between the cricoid cartilage and the top of the sternum. The subject was asked to swallow when being examined since the thyroid moves up when swallowing. The size of each lobe of the thyroid was compared to the size of the tip (terminal phalanx) of the thumb of the subject being examined and graded according to WHOIUNICEF/ICCIDD (2001) criteria. Two nutritionists performed inspection and palpation independently. Each nutritionist wrote a goitre grade on a piece of paper and gave it to the subject without looking at the piece of paper written by another nutritionist. The subject took the two pieces of paper to a field worker who recorded the goitre grades on the information sheet of each woman and child. During statistical analysis where the goitre grades of the two nutritionists did not coincide, the highest grade was used. 3.5.4.3 Reliability and validity (a) Reliability • Only trained nutritionists who had performed palpation during the previous studies palpated during the study. • The nutritionists who palpated were retrained thoroughly by a trained nutritionist (Director ofFNCO) and were checked for consistency and accuracy during training and pilot study. 85 • The researcher regularly visited the teams for supervision during palpation by the nutritionists. Each team was visited twice during the fieldwork. During these visits the researcher spent 2 days with the team and went to the households and schools. • No nutritionist performed more than 60 palpations a day. • Field workers were trained by the researcher on how to fill in information on the stickers and on the information sheets. • Based on WHOIUNICEFIICCIDD (2001) recommendations, women aged between 15 to 30 years and children aged between 8 to 12 years were palpated and the thyroid size graded. • Two observers performed palpations on each subject independently and both were recorded to assess performance during statistical analysis. (c) Validity • As stated earlier, ultrasonography, which is a more objective measure of thyroid size in children, was not available during the study. In the absence of ultrasonography, the standard procedure for inspection and palpation adapted from WHOIUNICEFIICCIDD (2001) was used. • During training each observer repeated palpation and the grades obtained were compared with other observers' and the trainers' grades until they coincided. The grades obtained by the trainer were used as the accepted standard (gold standard). 3.5.5 THE PREVALENCE OF GOITRE The prevalence of goitre refers to the percentage of children (8-12 years) and women of childbearing age (15-30 years) with goitre. Goitre is defined as thyroid size graded 1 or 2 according to WHOIUNICEFIICCIDD (2001) criteria. The prevalence of goitre was used to assess the severity ofIDD. 86 3.5.5.1 Cut-off point The WHOIUNICEF/ICCIDD (2001) epidemiological criteria for establishing IDD severity based on goitre prevalence in school-aged children were used (Table 13). Table 13. The epidemiological criteria for assessing the severity ofIDD based on the prevalence of goitre in school-aged children (WHOIUNICEF/ICCIDD, 2001). Degrees of IDD, expressed as a percentage of the total of number of children surveyed None Mild Moderate Severe Prevalence of goitre (TGR) 0-4.9% 5.0-19.9%, 20.0-29.9%, >/= 30.0% 3.5.5.2 Techniques to determine the prevalence of goitre The prevalence of goitre, which is the total number of primary school children and women with goitre over the total number of primary school children and women included in the study, was calculated using the goitre grades obtained during palpation (section 3.5.4.2). 3.5.6 SUSTAINABILITY Sustainability refers to whether iodine deficiency has been successfully eliminated and whether achievements can be sustained and maintained for the decades to come. 3.5.6.1 Cut-off point The program was regarded as sustainable when all of the WHOIUNICEF/ICCIDD 2001 sustainability goals had been met (Table 14). 87 3.5.6.2 Techniques to determine sustainability of the iodisation program A questionnaire (Appendix 7), bearing the information on programmatic indicators of sustainability adapted from WHOIUNICEFIICCIDD (2001), was administered to the director at FNCO who is also the chairperson of the IDD control task force and the Micronutrient task force. The researcher also reviewed the available reports to confirm the information obtained from the director ofFNCO. Using the information on salt iodisation (section 3.5.1 & 3.5.2) and unnary iodine concentration results (section 3.5.3) in the present study and the information obtained from the questionnaire (Appendix 7), the sustainability ofIDD elimination was determined based on the WHOIUNICEFIICCIDD (2001) sustainability goals. 3.7.6.3 Reliability and validity (a) Reliability The questionnaire was administered to one officer who has all the information on IDD, as she is the chairperson of the IDD control task force, the director of FNCO and the chairperson of the Micronutrient task force. This officer was also asked to show documentation on the responses for confirmation of the given information. (b) Validity All information included in the questionnaire was adapted from the WHOIUNICEFIICCIDD (2001) programmatic indicators of sustainability. 88 Table 14. Summary of criteria for monitoring progress towards sustainable elimination ofIDD as a public health problem (WHOIUNICEFIICCIDD, 2001). INDICATORS GOALS Salt iodisation Proportion of households using adequately iodised salt >90% Urinary iodine Proportion below 100flg/1 <50% Proportion below 50flg/1 <20% Programmatic indicators At least 8 of 10 Attainment of the following indicators: An effective, functional national body responsible to the government for the national program for the elimination of JDD. Evidence of political commitment of universal salt iodisation and the elimination oflDO. Appointment of a responsible executive officer for tbe JDD elimination Program. Legislation or regulations on universal salt iodisation Commitment to assessment and reassessment of progress in the elimination of JDD with access to laboratories able to provide accurate data on salt and urinary iodine. A program of public education and social mobilization on the importance of lDO and the consumption of iodised salt Regular data on salt iodine at the factory, retail and household level Regular laboratory data on urinary iodine in school-aged children with appropriate sampling for higher risk areas Cooperation from the salt industry in maintenance of quality control A database for recording of results or regular monitoring procedures, Particularly for salt iodine, urinary iodine and if available, neonatal TSH, With mandatory public reporting. 89 3.6 FIELD WORKERS Field workers were the nutritionists, nurses and other trained people who had been involved in data collection during the previous studies. These field workers were trained and standardized against one another and the trainers (the director ofFNCO and the researcher). 3.6.1 SELECTION AND TRAINING 24 field workers were recruited to form 4 teams of 6 people. Detailed letters were sent to the heads of FNCO, Ministry of Agriculture and Ministry of Health asking them to appoint nutritionists and nurses. A total of 8 nutritionists and 8 nurses were included for data collection. Unemployed people who have obtained Cambridge Overseas School Certificate (C.O.S.C, which is equivalent to grade 12 in South Africa) and have previously been involved in data collection were also recruited. A list of these people is available at FNCO and they were sent forms for application. A total of 8 of these unemployed people were selected according to their data collection experience. Each team was therefore composed of two nutritionists, two nurses and two unemployed people. All the field workers were trained intensively for two days by the trained and experienced nutritionist (Director of FNCO) on palpation using the standardized procedure (Appendix Il). The researcher also taught them on how to fill in the data sheets and how to collect urine and salt samples using the data collection guide (Appendix 9). 3.6.2 TASKS OF FIELD WORKERS AND RESEARCHER 3.6.2.1 Tasks offield workers In each team different tasks were given to field workers by the researcher as follows: • Nutritionists palpated the selected women and children and supervised the other data collectors during field work 90 • Nurses assessed the children and women for exclusion and collected urine and salt samples. • Unemployed people recorded information on the data sheets and stickers (Appendix 6). 3.6.2.2 Tasks of the researcher The task of the researcher was to plan and organize for the study, train and supervise the field workers and compile a report. A signed statement of the compiled tasks of the researcher is given in Appendix 9. A brief description of the task of the researcher is as follows: (i) Planning and organising The planning and organising for the study was done within one month (2nd to 27tn February 2002) • Using the population census data obtained from Bureau of Statistics, the researcher selected the number of clusters in each district and ecological zones. The researcher explained the selection methodology to the Statistian who selected the villages. • Plan the evaluation and monitoring of the salt iodisation program • Collect and review relevant information. • Write the proposal for funding to UNICEF and send it through FNCO. • Organize a meeting with the IDD control and micronutrient task forces for briefing on the activities of the study and support in supervision. • Write letters to Ministry of Education, Local government and Customs for approval of the study. • Collect all materials to be used in the study and arrange with laboratories in all the districts for storage of urine samples until collected for forwarding to central laboratory. • Develop data sheets, stickers for labelling (Appendix 6), a questionnaire (Appendix 7), data collection guidelines and supervisors' checklist (Appendix 9) • Recruit the 24 field workers. • Arrange for a pilot study and compile information and recommendations obtained. 91 • Develop and send consent forms to selected schools. • Arrange for transport of urine and salt samples from Maseru to Cape Town for chemical analysis. • Develop a questionnaire on programmatic indicators and ask the Director of FNCO to complete the questionnaire. Interview format used. (ii) Training and supervising • Train field workers using the data collection guide (Appendix 9) on random sampling, urine and salt sample collection, labelling and recording of information on the data sheets and stickers. • Teach supervisors (nutritionists) how to supervise during fieldwork, follow the data collection guidelines and fill in the supervisors' checklist. • Supervise each team alternatively to ensure that both fieldworkers and supervisors are doing the work efficiently. During this supervisory visits, the researcher also collected data • Check all the samples and data sheets during field visits (alternative supervisory visits) and, on arrival from the field, take to the central point for completion. • Pack urine and salt samples in batches for transport to Cape Town. Spend a week in Cape Town involved in chemical analysis of the samples 3.7 PILOT STUDY After training a pilot study was conducted for a day in 1 village and 1 school not included in the selected sample for the study. This pilot study was conducted to standardize thyroid size measurement, data collection and recording procedures. It was also undertaken to expose the field workers to problems that may be encountered in the field and to show them how to solve them. The trainers evaluated and standardized the measurements and data collection method during the pilot study. All4 teams were involved in data collection. Each team was given 30 children and 30 women. Field workers worked together in a team and according to their different tasks. The field 92 workers were evaluated for efficient work during data collection. The amount of time that would be taken to complete the survey in each cluster was also estimated. A total of 120 children and 120 women were included in the pilot study. There were no problems encountered in both the village and school and nothing was changed regarding the study procedure after the pilot study. It was estimated that one team would need take one day in one cluster, to collect data at household, retail and school level. 3.8 ETHICAL CONSIDERA TIONS The Ethics Committee of the Faculty of Health Sciences at the University of Free State gave its approval for conducting this study (Ethics document number ETOVS NR 32/02). A written approval was also obtained from the Ministry of Education, Ministry of Local government and Customs in Lesotho and from the chiefs and the headmasters of the selected villages and schools respectively. An informed consent form written in Sesotho and English (Appendix 12) had to be signed by the selected women and parents or guardians of children participating (first signature) and the children who participated in the study (second signature). Before signing the participants were assured of anonymity and confidentiality. Those who were not able to write signed with a cross. 3.9 STUDY PROCEDURES The researcher followed the procedures for the field workers followed logistics while the field procedures. 3.9.1 LOGISTICS Before data collection could start, the researcher followed the following procedures: • Letters were sent to the Ministry of Education, Local government, and Customs for approval (Appendix 13). After the approval was obtained, official letters were sent to the school principals and chiefs of the selected schools and villages respectively. Consent forms were sent together with the letters to the schools for the children aged 8 93 to 12 years to take to their parents for signatures. Letters were also sent to customs officers at all the commercial entry points in the country. These letters indicated the purpose of the study, dates of the visit and what was expected. • Messages were also broadcast through local radios indicating the villages, schools and entry points to be visited and the purpose of the study. • Clusters and entry points were allocated for each team. Three teams were allocated 8 clusters each and 5 entry points and 1 team was allocated 7 clusters and 1 entry point. 3.9.2 FIELD PROCEDURES Each team (6 people) went to the village and then to the school in each cluster and the procedures followed during data collection were as follows: • The field workers stayed at a chosen centre and travelled daily to the villages (clusters) and entry points. • In a village, households and retailers were randomly selected after the team had been introduced to the chief The purpose of the study was explained to each selected woman. She was asked to sign the consent form. Information on district, ecological zone, name, age and whether pregnant or not was collected and noted on the stickers (for urine and for salt samples) and on the data sheet. The woman was palpated using the standardized procedure for palpation (two observers palpated independently and recorded the thyroid size). Salt and urine samples were collected according data collection guide. • After collection of data at household level the team went to the government school in the same village. • At the school, the team was introduced to the principal, and, with the help of class teachers, children were randomly selected. The purpose and procedure of the study were explained to the teachers and the selected children. Children were asked to sign the consent forms, which had previously been signed by their parents. The children were palpated according to standardized procedure and urine samples collected as per 94 data collection guide. The information on the district, ecological zone, age and gender was collected for each child and noted on the stickers and data sheet. • The supervisor checked the data sheets, stickers and collected samples after each field visit and recorded this in the supervisors' checklist. • After collection of data in the selected villages and schools in each district the team visited the entry points and salt samples were collected according to the data collection guide. • The collected salt and urine samples were stored in the refrigerators at the districts' laboratories. When data collection was finished in the districts the samples were transported to the central laboratory in Maseru district where they were rechecked and relabelled with a permanent marker by the researcher. The researcher stored the samples in batches in the boxes (salt samples) and in the refrigerator (urine samples) for a maximum of two weeks and transported them to Cape Town for analysis. 3.10 STATISTICAL ANALYSIS Statistical analysis was performed by the Department of Biostatistics at the University of the Free State using the SAS software (SAS Institute Inc., 1989). The results were summarized by frequencies and percentages (categorical variables) and by means and standard deviations and ranges or medians in the case of skew distributions (numerical variables). Subgroup comparisons were done using the Kruskall-Wallis test for numerical variables and chi-squared tests for categorical variables. Agreement between observers was analysed using Kappa statistics with 95 percent confidence intervals (Cl). 95 percent confidence intervals taking the design effect of the cluster design into account were calculated for the main categorical outcomes. The statistical significance of associations between variables was assessed using Mantel-Haenszel chi-squared tests, adjusting for district. Associations were assessed between the following variables: • Salt iodine content and thyroid size. • Salt iodine content and urinary iodine concentration. 95 3.11 PROBLEMS ECOUNTERED DURING THE STUDY The following problems were encountered during the study. These problems were, however, solved and except for the Maseru Border post all samples were collected as required. • Some selected women and children were not able to give urine therefore the data collectors had to return later for those urine samples. • At some entry points, salt did not pass through on the sampling day or less than the required samples were obtained, therefore data collectors had to return the next day. Because of this problem, several days were spent at Maseru border gate and, to stay within time schedule, 47 instead of 50 salt samples were collected. • Some salt samples collected at household level were less than 10grams. However, the available amounts were standardized and chemical analysis continued. • During statistical analysis some (3 out of 930) data sheets for children were discarded due to ages, which did not fall within the recommended range of the study sample. 18 (out of 930) data sheets for children and 6 (out of 930) for women were also discarded due to duplication of identification numbers on urine samples. However, 99.7 percent of data sheets for children were included for palpation, while 98.1 percent of data sheets for children and 99.4 percent for women were included for urinary iodine analysis. This gives a more than 95 percent response rate, which is sufficient for interpretation of the results. 3.12 SUMMARY The study was undertaken in all ten districts and four ecological zones. 31 clusters were selected based on the number of households in each district and ecological zone. In each cluster 30 primary school children aged 8 to 12 years, 30 women of childbearing age and 2 retailers were randomly selected. All commercial entry points were also visited. Urine samples were collected from children and women and salt samples from women, retailers and entry points. The women and children were also palpated for thyroid size and a questionnaire was administered to a member of the IDD control program to elicit information on the sustainability of the program. 96 Accurate methods and techniques had to be selected to analyse the samples. Methods were selected based on WHOIUNICEF/ICCIDD (2001) criteria and were standardized to ensure validity and reliability. The laboratory used for chemical analysis of the results has successfully participated in international quality control exercises. Urine and salt samples were analysed for iodine content and the thyroid palpated to estimate the prevalence of IDD. The criteria for selection of field workers were followed, and they were trained intensively using a field guide and the standardized procedure for palpation. A pilot study was undertaken to identify possible shortcomings in the chosen methods and changes were brought about where necessary. During the pilot study thyroid size measurements results of the field workers were standardized against the results obtained by the trainer. The supervisors were selected based on field work experience in IDD surveys, supervised during field work, recorded and gave daily reports to the researcher. Throughout the procedure of the study the researcher was involved in logistics, training and overall supervision to ensure that techniques were followed as recommended. Except for the Maseru border post where 47 instead of 50 salt samples were collected, all data was successfully obtained as planned. The results were chemically and statistically analysed. During statistical analysis some information sheets indicated ages above 12 years for children, therefore they were not included for analysis. Similarly some urine sample numbers were duplicated, therefore these samples were not included for analysis. Few samples were, however, discarded resulting in a sufficient sample (>95%) for analysis and interpretation of results. The results are reported in the following chapter. 97 CHAPTER 4: RESULTS 4.1 INTRODUCTION The fieldwork started from 4th February and ended on the 24th February 2002. The results obtained from salt and urine analysis and assessment of goitre enlargement are reported in this chapter. Using medians and percentages, salt iodine content is reported by different brands available in the country, by districts and ecological zones and at household level. The iodine content of the two types of salt (coarse and fine) used in the country is also shown in this chapter. Coarse salt packed in 20kg bags or more is meant for animal consumption while coarse salt packed in 500g or lkg bags, is meant for human consumption. Fine salt is packed in lkg or 500g bags and is meant for human consumption. The results on urinary iodine concentration for both the children and women are expressed in median and reported by districts and ecological zones. The prevalence of goitre that was determined by assessment of thyroid size of both the children and women is reported as the prevalence by age and gender and by districts and ecological zones. The associations between the salt iodine content and urinary iodine concentration and the prevalence of goitre are also indicated. Finally, the results on sustainability of the iodisation program obtained from the questionnaire (indicating the programmatic indicators of sustainability), salt iodine content and urinary iodine concentration are reported. 4.2 DESCRIPTION OF STUDY GROUP A total of 930 and 186 salt samples were successfully collected at household and retail level respectively and analysed (Table 15). At entry point level 107 salt samples were collected and analysed instead of the expected 110samples due to time constraints. The expected sample size at both school and household level was 1 860 (930 children and 930 women). No children and women met the exclusion criteria for the study. During the fieldwork, 930 children were palpated and gave urine samples and 930 women were palpated and gave urine and salt samples. However, 3 information sheets for the children were not included for statistical 98 analysis because the ages did not fall in the range of 8 to 12 years. There was also a duplication of the recorded urine sample numbers and these duplicated samples were not included for statistical analysis. Therefore a total of927 children (486 females and 441 males) and 930 women (64 pregnant) who were palpated, and 912 children (477 females and 435 males) and 924 women who gave urine samples, were included in the statistical analysis of the results. Only 3 data sheets for children were not included for palpation while 18 data sheets for children and 6 data sheets for women were not included for urinary iodine analysis. In total thyroid size of 1857 women and children were palpated, 1836 urine samples were analysed for iodine concentration and 1223 salt samples were analysed for iodine content. These resulted in a more than 98 percent response rate for children and women, which is sufficient for the determination ofIDD status in a population. Table 15. The National and district level sample size of the study DISTRICTS NUMBER NUMBER OF NUMBER OF SALT SAMPLES (n) PALPATED (n URINE SAMPLES (n C W C W HOUSEHOLD RETAll. ENTRYPOIN MOKHOTLONG 30 30 30 30 30 6 10 BUTHABUTHE 30 30 28 30 31 6 10 LERIBE 150 150 148 150 150 30 * BEREA 90 90 88 90 90 18 20 MASERU 268 270 266 266 270 54 47 MAFETENG 119 120 117 118 119 24 10 MOHALESHOEK 90 90 90 90 90 18 * QUTIDNG 60 60 58 60 60 12 * QACHAS'NEK 30 30 30 30 30 6 10 THABATSEKA 60 60 57 60 60 12 * TOTAL 927 930 912 924 930 186 107 C= Children W=Women *No commercial entry point 99 4.3 SALT IODISATION The results on the iodine content of salt at entry point level, retail level and household level are presented in this section. These results are also presented by ecological zones and districts as well as by different brands available in the country. The results are reported in medians and not in means because of skew distributions and small sample sizes obtained from some entry points and some districts. The medians are therefore more stable estimates than are the means. Coarse salt, which is salt meant for animal consumption (usually packed in bags of 20kg or more) and fine salt meant for human consumption (usually packed in 500g or 1kg bags) are the only types of salt available in the country. The results on the iodine content of these two different types of salt are also presented. At retail level the brand names of some salt packed in 20kg bags (coarse salt) were not identified on the bags and are referred to as "Unknown coarse salt" in this section. Most of the salt samples at household level were kept in different containers and some households did not know the brand names while some were not sure of the brand names of the salt. Therefore the iodine content at household level is not shown according to brand of salt. 4.3.1 ENTRY POINT LEVEL The median iodine concentration of salt at entry point level was 36.2 ppm, which ranged from 30.5 ppm (Monontsa) to 55.4 ppm (Sani-top) in the different entry points (Table 16) (p=0.024). There was a large variation in the iodine concentration of salt at (0-149ppm in Maseru) and between (12.0-50.6ppm in Monontsa and 0-149ppm in Maseru) the border gates. According to Table 17, the median iodine content of different brands at entry point level ranged from 12.1ppm (Econo) to 44.4ppm (Orange) (p=0.050). A large variation was also observed in the iodine content of salt within the brands (where the largest variation was 4.9ppm to 143.3ppm for Orange salt) and between the brands (1.9-35.9ppm for Dwaga and 4.9-143.3ppm for Orange). Except for some samples of coarse salt, all the salt samples were labeled "iodised salt". 100 Table 16. The iodine concentration of salt at entry point level Entry points Sample Iodine concentration (ppm) SiZe Mean Range Median 25th percentile 75th percentile QACHA'SNEK 10 28.5 3.9-45.4 34.9 12.9 37.3 SANI-TOP 10 57.6 22.2-119.8 55.4 41.5 69.9 (MOKHOTLONG) MONONTSA 10 30.1 12.0-50.6 30.5 15.0 44.5 (BUTHA-BUTHE) VANROYEN 10 41.6 16.1-88.2 38.3 32.6 45.3 (MAFETENG) MAPUTSOE (BEREA) 20 44.9 8.8-143.3 36.2 31.2 52.1 MASERU 47 31.1 0-149.0 34.9 12.1 41.8 TOTAL 107 36.8 0-149.0 36.2 18.2 45.4 Table 17.The iodine concentration of different salt brands at entry point level Brands Sample Iodine concentration (ppm) SiZe Mean Range Median 25th percentile 75th percentile Marina 23 41.5 2.9-119.8 36.2 30.9 50.6 Cerebos 32 33.0 0-88.2 36.7 17.9 44.6 Sun 7 41.9 16.0-89.5 41.6 16.1 63.0 Crystal 11 33.5 8.8-50.5 34.3 28.9 43.7 Dwaga (Coarse salt) 9 19.7 1.9-35.9 17.2 15.0 31.6 Pak 9 47.4 15.4-149.0 37.9 24.3 49.4 Econo 7 22.2 0-47.1 12.1 5.0 45.8 Orange 9 56.3 4.9-143.3 44.4 37.9 55.8 101 Table 18 shows that only 25.2 percent of salt at entry point level complied with the legal requirements of 40ppm to 60ppm of iodine in salt when entering the country. Few samples (1l.2%) exceeded the legal limit and their iodine content reached up to 149 ppm. More than half of the salt samples (37.4 + 26.2 = 63.6%) were below the legal limit of which 26.2 percent were markedly under-iodised or not iodised at all. Table 18. The distribution of iodine concentration of salt at entry point level Iodine concentration Number of salt range samples n % 0-19 28 26.2 20-39 40 37.4 40-60 27 25.2 61-80 6 5.6 >80 6 5.6 4.3.2 RETAIL LEVEL The median iodine concentration at retail level was 37.3 ppm (Table 19), which ranged from 12.4ppm in the Buthabuthe district to 50.2ppm in the Thabatseka district (p=0.010). The iodine content of salt at retail level ranged from 0 to 423.6 ppm. Similar to the results obtained at entry point level, there was a large variation of iodine content of salt within (l. 7-423. 6ppm in Leribe) and between (5.6-40.8ppm in Buthabuthe and l.7-423.6ppm in Leribe) the districts. Similar to the entry point level, at retail level all salt samples were labeled "iodised salt" except for some coarse salt samples. 102 Table 19. The iodine concentration of salt at retail level District Sample Iodine concentration (ppm) SIze Mean Range Median 25th percentile 75th percentile MOKHOTLONG 6 20.8 5.8-38.5 18.4 10.6 33.2 BUTHABUTHE 6 19.8 5.6-40.8 12.4 7.2 40.6 LERIBE 30 108.6 1.7-423.6 42.6 15.7 128.8 BEREA 18 35.6 0-91.3 34.3 17.7 50.1 MASERU 54 37.4 3.9-83.5 39.8 27.9 49.1 MAFETENG 24 35.4 7.5-58.3 35.1 24.6 48.7 MOHALESHOEK 18 34.9 19.6-51.9 35.2 28.0 41.2 QUTHING 12 72.0 19.7-254.8 49.0 36.7 64.2 QACHAS'NEK 6 31.3 16.5-50.7 30.4 27.3 32.7 THABATSEKA 12 52.3 13.9-106.8 50.2 33.3 58.4 TOTAL 186 50.1 0-423.6 37.3 23.0 50.7 According to Table 20, the median iodine concentration was higher in the Senqu river valley (46.1ppm) and lower in the Mountains (28.3ppm) than in the other ecological zones (p=0.045). A large variation in the iodine content of salt was observed in the Lowlands (1.7-423.6ppm) while a small variation was observed in the Senqu river valley (27.5-69.8ppm). Table 20. The iodine concentration of salt at retail level by ecological zones Ecological zones Sample Iodine concentration (ppm) SIze Mean Range Median 25th percentile ts:percentile FOOTHILLS 30 49.9 12.7-254.8 41.2 27.4 51.8 LOWLANDS 114 55.4 1.7-423.6 37.3 25.0 50.1 SENQU-RIVER 6 47.6 27.5-69.8 46.1 44.4 51.8 VALLEY MOUNTAINS 36 30.8 0-91.3 28.3 8.4 44.9 103 The median iodine concentration of different brands of salt ranged from 3.9ppm for Dwaga salt to 88.4ppm for Orange salt (p<0.001) (Table 21). The iodine content of brands varied considerably within (where the largest variation was 0-423.6ppm for Orange salt) and between (3.8-13.9ppm for Dwaga salt and 0-423.6 for Orange salt) the brands. Table 21. The iodine concentration of different brands of salt at retail level Brand of salt Sample Iodine concentration (ppm) SIze Mean Range Median 25th percentile 75th percentile Econo 31 23.6 5.6-72.7 19.9 16.5 28.9 Cerebos 106 37.9 5.8-59.5 40.1 30.8 48.9 Orange 22 152.8 0-423.6 88.4 53.2 261.6 Dwaga (coarse salt) 3 7.2 3.8-13.9 3.9 3.8 13.9 Unknown-coarse salt 19 51.4 1.7-254.8 28.4 10.6 58.3 Marina 5 41.4 27.4-58.6 42.3 28.0 50.5 According to Table 22, the median iodine concentration was 28.3ppm for coarse salt and 38.3ppm for fine salt (p=0.213). The iodine concentration range within these two types of salt differed considerably (1.7-254.8ppm for coarse salt and 0-423.6ppm for fine salt). Table 22. The iodine concentration per type of salt at retail level Type of salt Sample Iodine concentration (ppm) SIZe Mean Range Median 25th percentile ts: percentile Coarse salt 22 50.1 1.7-254.8 28.3 11.7 58.3 Fine salt 164 50.2 0-423.6 38.3 25.4 50.7 Table 23 indicates that 33.3 percent of retail salt samples were within the legal requirements of 40ppm to 60ppm. Only a few samples (11.9%) exceeded the legal specifications, while most samples (54.8%) were below this. Very few coarse salt samples (9.1%) and most of the fine 104 salt (37%) were within the legal specifications. Most samples of coarse salt (45.5%) and fewer samples of fine salt (18.9%) were below 20ppm. Table 23. The distribution of iodine concentration of salt at retail level Type of salt The percentage of salt samples in each iodine content range 0-19ppm 20-39ppm 40-60ppm 61-80ppm >80ppm n % n % n % n % n % Fine 31 18.9 56 34.2 60 37.0 4 2.4 13 7.9 Coarse 10 45.5 5 22.7 2 9.1 0 0 5 22.7 Total 41 22.0 61 32.8 62 33.3 4 2.2 18 9.7 According to Table 24, most of the salt samples in the Senqu river valley (66.7%) and very few in the Foothills (23.3%) were within the legal requirement of salt iodisation at 40ppm to 60ppm. No salt samples in the Senqu river valley were below 20ppm, while most samples in the Foothills (40%) were below this. Table 24. The distribution of iodine concentration of salt in each of the ecological zones at retail level Ecological zones The percentage of salt samples in each iodine content range 0-19ppm 20-39ppm 40-60ppm 61-80ppm >80ppm N % n % n % n % n % FOOTHlLLS 12 40.0 8 26.7 7 23.3 2 6.7 1 3.3 LOWLANDS 22 19.3 43 37.7 35 30.7 1 1 13 11.4 SENQU-RIVER VALLEY 0 0 1 16.7 4 66.7 1 16.7 0 0 MOUNTAINS 7 19.4 9 45 16 44.4 0 0 4 11.1 105 4.3.3 HOUSEHOLD LEVEL Nationally, the median iodine concentration at household level was 38.5ppm, which ranged from 29.2ppm in the Thabatseka district to 43.2ppm in the Quthing district (p15ppm). This proportion of households using adequately iodised salt is less than the 90 percent recommended by WHO/UNICEFIICCIDD (2001). More of the fine salt samples (93.7%) than of the coarse salt samples (60.5%) were adequately iodised. 107 Table 28. The use of adequately iodised salt at household level Type of salt Number of salt samples in each category of Salt iodisation Oppm 15ppm n % n % n % Coarse 11 5.8 64 33.7 115 60.5 Fine 4 0.5 43 5.8 693 93.7 Total 15 l.6 107 1l.5 808 86.9 (95% Cl 83.1%; 90.7%) 4.4 URINARY IODINE CONCENTRA nON The median urinary iodine concentration and the distribution of urinary iodine levels in categories showing the severity of iodine deficiency according to the WHOIUNICEFIICCIDD (2001) report are presented in this section. These results are presented at national and district level as well as by ecological zones. 4.4.1 PRIMARY SCHOOL CHILDREN The analysis of the urine samples showed that the median urinary excretion level at national level was 214.7Jlgll indicating a more than adequate iodine intake according to the WHOIUNICEFIICCIDD (2001) report (Table 29). Adequate iodine intake is indicated by the urinary iodine concentration of 100Jlgli to 199Jlg/l. The median urinary iodine concentrations ranged from 62.9Jlgll (Qachas'nek) to 302.6Jlg/l (Mafeteng) in the different districts (p15ppm), most came from the women who had urinary iodine concentration in the excessive iodine intake range (48.0%) and very few came from women who had urinary iodine concentration in the mild iodine deficiency range (4.1%). 116 Table 37. The association between urinary iodine concentration and salt iodine content IODINE CONTENT THE PERCENT AGE OF WOMEN ACCORDING TO SEVERITY CATEGORIES OF URINARY IODINE CONCENTRATION. <20 J..Lg 20-49 J..Lg 50-99 J..Lg 100-199 J..Lg 200-300 J..Lg 300+ J..Lg severe moderate mild adequate more than excessive adequate intake 0 % 0 6.7 20.0 13.3 13.3 46.7 n 0 1 3 2 2 7 15 % 15.0 4.1 8.0 20.3 14.7 48.0 n 40 33 64 163 118 385 4.5 THYROID SIZE AND THE PREVALENCE OF GOITRE Thyroid size and the prevalence of goitre will be presented in this section at national and district level as well as by ecological zones, age and gender. The size of the thyroid gland of each child and woman was visually inspected and palpated and was graded according to the criteria of the WHOIUNICEF/lCCIDD (2001). The limited usefulness of palpation method during the initial stages of salt iodisation has been documented. Therefore the results on the prevalence of goitre in the study will be used to follow IDD trend in Lesotho not to show the impact of salt iodisation. Each observer graded the subject independently and the goitre grades of both (for each of the four teams) were recorded. During interpretation of data, when the goitre grades of both observers did not the same the highest was used (i.e. if one observer graded 0 and other graded 1, goitre grade 1 was used for interpretation). This was done to ensure that the possibility of the existence of goitre was taken into account. The consensus of observers regarding goitre grades was therefore measured. The results obtained were in three categories; both observers scored 0 (grade 0), either of the observers scored 1, or both observers scored 1 (grade 1) and both observers scored 2 (grade 2). The category "either of observers" included the cases where both observers got grade 1 and 117 where one of them grade 1. The prevalence of goitre (goitre rate) included the rate of both palpable (grade 1) and visible (grade 2) goitre. For interpretation of the results and discussion, the prevalence of goitre was obtained from both goitre grades 1 and 2 using categories "either of the observers scored 1" and "both observers scored 2" respectively. There was no discrepancy in the observation of goitre grade 2 between the observers. 4.5.1 AGREEMENT BETWEEN OBSERVERS Unlike the children where only grade 0 and 1 were observed, all three goitre grades (0,1 and 2) were observed in women, therefore, the weighted Kappa was used for women rather than the simple Kappa. The consensus within teams 1, 3 and 4 was good with 95 percent confidence intervals and Kappa values above 0.80 in children (Table 38). Team 2 had a poorer consensus. However, for the women, the consensus of both teams 1 and 3 was not as good as with the children. The values on Table 39 shows that the consensus between the observers was better in children than in women. Table 38. The Kappa values for the classification of the goitre grades obtained by two observers in each team TEAMS SUBJECTS KAPPA 95% CONFIDENCE INTERVALS VALUE~ Lower limit Upper limit 1 Children 0.89 0.79 l.00 Women 0.54 0.40 0.68 2 Children 0.69 0.52 0.85 Women 0.68 0.56 0.80 3 Children 0.93 0.86 l.01 Women 0.82 0.71 0.94 4 Children 0.97 0.92 l.02 Women 0.93 0.85 l.00 118 4.5.2 PRIMARY SCHOOL CHILDREN Table 39 indicates that only grade 0 (no palpable goitre) and grade 1 (palpable but non visible goitre) were prevalent in children in all the children palpated. Grade 2, which is visible goitre, was not observed in any of the districts. A higher percentage (93.4%) and a lower percentage (78.3%) of grade 0 goitre were found in the Quthing and Thabatseka districts respectively than in the other districts. The prevalence of goitre for the whole country was 10.7 percent (either of the observers scored 1), which indicates mild IDD (WHOIUNICEFIICCIDD, 2001). IDD is eliminated in a population when the prevalence is less than 5 percent. The prevalence of goitre ranged from 6.6 percent in Quthing to 22.6 in the Buthabuthe district (p=0.039) indicating mild to moderate IDD. The prevalence of goitre where both observers scored 1 was 8.5 percent, which also indicates mild IDD. According to Table 40 it is clear that iodine deficiency as represented by the prevalence of goitre (either of the observers scored 1) is higher in the Mountains (18. 1%) than in the Lowlands (6.7%) (p<0.001). Goitre was not prevalent in the Senqu river valley. The results on Table 41 show that goitre prevalence increases with age in children (p=0.024, adjusted for district p=0.023). The prevalence of goitre was lower (4.3% and 8.9%) in children aged 8 and 9 years respectively than in children aged 10 and 11 (12.3%) and children aged 12 years (12.9%). 119 Table 39. Goitre grade and the prevalence of goitre in children by districts DISTRICTS PERCENT AGE OF CHILDREN ACCORDING PREVALENCE TO GOITRE GRADE OF GOITRE (%)' Number of 0 1 (either of I (both children (n) observers)" observers) n % n % n % MOKHOTLONG 30 26 86.7 4 13.3 4 13.3 13.3 BUTHABUTHE 30 24 80.0 7 23.3 6 20.0 23.3 LERIBE 150 135 90.0 15 10.0 15 10.0 10.0 BEREA 90 84 93.3 6 6.7 5 5.6 6.7 MASERU 268 240 89.6 28 10.5 17 6.3 10.5 MAFETENG 119 111 93.3 8 6.7 8 6.7 6.7 MOHALESHOEK 90 80 89.0 10 ILl 9 10 11.1 QUTHING 60 58 96.7 4 6.7 2 3.3 6.7 QACHAS'NEK 30 26 86.7 4 13.3 4 13.3 13.3 THABATSEKA 60 47 78.3 13 21.7 9 15 21.7 TOTAL 927 828 89.3 99 10.7 79 8.5 10.7 (95% Cl 8.1%; 13.3%) * obtained from gortre grade I "either of the observers" b where both observers or one of them scored grade I Table 40. Goitre grade and the prevalence of goitre in children by ecological zones Ecological zones Percentage of children according to goitre grade The prevalene n 0 1 (either of 1 (both of of goitre (%)* observers) b observers) n % n % n % FOOTHILLS 150 125 83.3 25 16.7 20 14 16.7 LOWLANDS 537 501 93.3 36 6.7 30 5.4 6.7 SENQURIVER 30 30 100 0 0 0 0 0 VALLEY MOUNTAINS 210 172 81.9 38 18.1 29 13.8 18.1 TOTAL 927 828 89.3 99 10.7 79 8.5 10.7 *obtamed from goitre grade I "either of the observers" b where both observers or one of them scored grade I 120 Table 41. Goitre grade and the prevalence of goitre in children by age Age group n Percentage of children according to goitre grade The prevalence 0 1 (either of 1 (both observers) of goitre (%)* observers) b n % n % n % 8 139 138 99.3 6 4.3 1 0.7 4.3 9 157 147 93.6 14 8.9 10 6.4 8.9 10 212 185 87.3 32 15.1 27 12.7 12.3 11 187 168 89.8 23 12.3 19 10.2 12.3 12 232 210 90.5 24 10.3 22 9.5 12.9 *obtainedfrom goitre grade 1 "either of the observers" b where both observers or one of them scored grade 1 Table 42 demonstrates that the goitre prevalence of 14.0 percent in females was higher than that of males (7.0%) (p15 808 662 8l.9 73 19.0 137 17.0 9 l.1 b where both observers or one of them scored grade 1 125 4.6 SUSTAINABILITY OF SALT IODISATION PROGRAM According to the WHOIUNICEF/ICCIDD (2001) the sustainability indicators involve a combination of median urinary iodine levels in the target population, availability of adequately iodised salt at household level and a set of programmatic indicators, which are regarded as evidence of sustainability. To assess the programmatic indicators, a questionnaire, bearing information on the programmatic indicators of sustainability, was administered to one officer. This officer, the Director ofFNCO has been fully involved in the salt iodisation program since it was initiated. The information obtained was verified by documentation when available. The responses from the Director of FNCO who is the chairperson of the micronutrient and the IDD control task force are shown in Table 47. These responses indicate that only 4 of the 10 programmatic indicators of sustainability have been attained. Table 48 shows the results on the achievement of the WHOIUNICEF/ICCIDD (2001) sustainability goals by the salt iodisation program. All urinary iodine goals have been achieved. Fewer than half (4 out of 10) of the goals of the programmatic indicators have been attained. At least 8 out of the 10 programmatic indicators have to be attained, indicating that the programmatic indicators do not achieve the goals for sustainable elimination ofIDD. 86.9 percent of households (that is, slightly less than 90%) use adequately iodised salt. According to the WHOIUNICEF/ICCIDD (2001) all goals for sustainable elimination as a public health problem should be achieved. Therefore the results on Table 49 show that the salt iodisation program for IDD elimination in Lesotho requires further programmatic inputs before it could be considered a program with a good potential for sustainability. 126 Table 47. Responses to the questionnaire based on programmatic indicators of sustainability INDICATORS ATTAINMEN' COMMENTS OFTHE INDICATORS Existence of an effective, functional national YES IDD control task force is multi- body responsible to the government for disciplinary and is coordinated by national program for the elimination ofIDD. FNCO Evidence of political commitment of NO There is no evidence of universal salt iodisation and the political commitment to the elimination ofIDD elimination ofIDD* Appointment of a responsible executive YES The director ofFNCO (the officer for the IDD elimination program Coordinating body) is responsible Legislation or regulations on universal YES The legislation which cover salt iodisation iodisation of both human and animal salt was drafted in 1994 and promulgated in 2000 Commitment to assessment and re- NO Only one person was trained in assessment of progress in the elimination of IDD with access to laboratories able to urinary iodine analysis and the provide accurate data on salt and urinary only available laboratory (at the iodine National University of Lesotho) IS quality assured externally. A program of public education and NO Radio messages are no longer social mobilization on the importance of IDD and the consumption of iodised salt sent. Pamphlets, posters and booklets are being distributed at a very slow rate. * 127 Regular data on salt iodine at the factory, NO This is not done regularly because of retail and household level costs encountered (especially transportation of samples) to perform analysis outside the country (in South Africa). Customs officers and health inspectors no longer do regular checks using the spot tests Regular laboratory data on urinary iodine NO This is also not done regularly due to in school-aged children with appropriate sampling for higher risk areas high costs encountered during analysis outside the country. Cooperation from the salt industry in YES The recent assessment in South maintenance of quality control Africa (from where Lesotho gets its salt) indicated that the South African salt industry is in a strong position to supply the required amount of iodised salt to the market to achieve the goal of at least 90% of house- holds using adequately iodised salt before 2005 (Jooste, 2001). A database for recording of results or NO All studies conducted are in written regular monitoring procedures, particularly reports of which some copies have for salt iodine, urinary iodine and if been misplaced and are not available, neonatal TSH, with mandatory readily available to the public. * public reporting. *There was no documentation to support the statement. 128 Table 48. Results based on the criteria for monitoring progress towards sustainable elimination ofIDD as a public health problem INDICATORS GOALS RESULTS OBTAINED IN THE PRESENT STUDY SALTlODISA TION >90% 86.9% (95%CI 83.1%; 90.7%) Proportion of households using adequately iodised salt URINARY IODINE Proportion below 100J..lg/1 <50% 21.5% (95% Cl 15.1%; 27.9%) for the children, 17.9% (95% Cl 14.0%; 22.0%) for the women Proportion below 50J..lg/1 <20% 10.1% (95% Cl 6.0%; 14.2%) for the children, 9.8% (95% Cl 6.7%; l3.0%) for the women PROGRAMMA TIC INDICATORS At least 8 Attainment of the indicators out of 10 Only 4 indicators are attained 4.7SUMMARY At entry point level 107 salt samples were collected and analysed instead of the expected 110 samples. Only 3 data sheets for children were not included for palpation while 18 data sheets for children and 6 data sheets for women were not included for urinary iodine analysis. This resulted in a more than 98 percent response rate. The median iodine concentration of salt was 36.2ppm (ranging from 30.5-55.4ppm at the different entry points) and 37.3ppm (ranging from 12.4-50.2ppm in the different districts) at entry point and retail level respectively. Among the different brands, the median iodine concentration ranged from 12.Ippm to 44.4ppm at entry point level and from 3.9ppm to 88.4ppm at retail level. A large variation was observed between and within the brands. The median iodine content of fine salt (38.3ppm at retail and 48.3ppm at household level) was higher than that of coarse salt (28.3ppm at retail and 33.5ppm at household level). At household level, the median salt iodine content was 38.5ppm, which 129 ranged from 29.2ppm to 43.2ppm in the different districts. 98.4 percent of households used iodised salt (only 1.6 percent used non iodised salt) and 86.9 percent used adequately iodised salt. The median salt iodine content was lower in the Mountains (28.3ppm at retail and 33.lppm at household level) than in the Lowlands (37.3ppm at retail and 40.2ppm at household level). The analysis of the urine samples showed that the median urinary excretion for children was 214.7Jlg/l indicating a more than adequate iodine intake according to the WHOIUNICEFIICCIDD (2001) report (Adequate intake range is 100-199JlglI). The median urinary iodine concentration ranged from 62.9Jlg/l in the Qachas'nek district to 302.6Jlg/l in Mafeteng district, which indicates mild iodine deficiency to excessive iodine intake. There was no significant difference between the median urinary iodine concentration of girls (212.6JlglI) and boys (219.3JlglI). Iodine deficiency was higher in the Mountains (median of 99.30Jlg/l) than in the Lowlands (median of 256.0 ug/l). Similar results were obtained from the women of childbearing age where the median urinary iodine excretion was 280.IJlglI, which also indicates a more than adequate iodine intake according to the WHOIUNICEFIICCIDD (2001) report. The median urinary iodine concentrations ranged from 124.8Jlgll (Thabatseka) to 381.6Jlg/l (Mohaleshoek) in the different districts indicating adequate to excessive iodine intake. This median urinary iodine concentration was higher in the Lowlands (329.9JlglI) than in the Mountains (182.6Jlgll), and was higher in non-pregnant women (283JlglI) than in pregnant women (212Jlg/l). The median urinary iodine concentration of 21.5 percent of the children and 17.9 percent of women was in the severe to mild iodine deficiency ranges. The median urinary iodine concentrations of very few children (10.1 % and 21%) and women (9.8% and 17.9%), which were lower than the cut off points of 20 percent and 50 percent respectively, were lower than 50Jlgli and l Ouug/l respectively, indicating that IDD has been eliminated as a public health problem. More than one third of the children (36%) and almost half of the women (47.2%) had urinary iodine concentrations in the excessive iodine intake range. Although not statistically significant, of the women who were in the adequate intake range, more (20.3%) used adequately iodised salt than non-iodised salt (13.3%). 130 Goitre grade 0 and 1 goitre were prevalent among the children. The prevalence of goitre in children for the whole country was 10.7 percent, which indicates mild IDD (WHOIUNICEFIICCIDD, 2001). This prevalence ranged from 6.6 percent to 22.6 percent in the different districts indicating mild to moderate IDD (elimination of IDD is indicated by the prevalence less than 5%). IDD was observed more in females (14.0%) than in males (7.0%) and was less (4.3%) in children aged 8 than in children aged 12 years (12.9%). In women, goitre 0, 1 and 2 were prevalent and the prevalence of goitre for the whole country was 19.4 percent, which indicates mild iodine deficiency. This prevalence ranged from 6.7 percent (Thabatseka district) to 36.7 percent (Berea district) and indicates mild to severe iodine deficiency according to the WHOIUNICEFIICCIDD (2001). Similar to the results of the children, IDD in women was observed more in the Mountains (17.7%) than in the Lowlands (14.3%). The prevalence of goitre also increased with age from the age group of 15 to 19 (17.3%) to the age group of 20 to 25 (22 %) and decreased in the age group of 26 to 30 (18.4%). There was a significant relationship between the goitre grade of the women and salt iodine content, where 6.7 percent of the women with grade 2 goitre used non iodised salt rather than adequately iodised salt (1.1%). The responses on the programmatic indicators of sustainability indicated that the iodisation program in Lesotho has attained 4 indicators instead of 8 or more. 86.9 percent (which is slightly lower than the recommended 90%) of salt samples were adequately iodised at household level. Therefore salt iodisation and the programmatic indicators do not reach the WHOIUNICEFIICCIDD (2001) sustainability goals. Only the urinary iodine excretion reached sustainability goals indicating that salt iodisation program in Lesotho requires additional programmatic inputs before it can be considered as sustainable. 131 CHAPTER 5:DISCUSSION 5.1 INTRODUCTION In this chapter the important observations from the results on salt iodisation, urinary iodine concentration, thyroid size, and sustainability of the salt iodisation program will be discussed. Where possible the results obtained in this study are compared to the results of other relevant studies of a similar nature, as reported in the literature available. Throughout the discussion, the trends and differences that were observed in the previous studies conducted in Lesotho and the present study will be highlighted in order to interpret the findings and identify possible reasons for changes, or lack thereof. 5.2 LIMITATIONS OF THE STUDY The limitations of this study were as follows: 1. An inspection and palpation method, which is less reliable especially when goitres are small, was used instead of ultrasonography to assess the thyroid size of both women and children. This was because ultrasonography, which is a more precise and objective measurement, is not available in the country. It has, however, been indicated that in the absence of ultrasonography, inspection and palpation provides information on the prevalence of goitre in a population. Therefore palpation in the present study was used to give an indication of the prevalence of goitre to track progress not as an impact of salt iodisation on the thyroid size. 2. Thyroid stimulating hormone (TSH) in neonates, which has an additional advantage of highlighting the fact that iodine deficiency directly affects the developing brain, was not assessed in the study. TSH assays are not available in the country. 3. The use of goitrogenic foods as well as the nutritional status of the women and children, were not investigated during the study, due to limited funds. The investigation is important because studies have shown that goitrogenic food and water- borne goitrogens can aggravate goitre. General malnutrition and deficiency of iron, selenium and vitamin A also exacerbate JDD. Although iodine intake has not been 132 investigated in Lesotho, studies have indicated persisting mild to severe IDD while the use of iodised salt was increasing. Therefore it would have been of benefit to investigate the role of goitrogens and micronutrient deficiencies in the prevalence of IDD in Lesotho. 4. Due to limited funds, iodine intake was also not investigated. The use of iodine containing supplements, herbal medicines and iodine rich substances affect the iodine status of a person. Despite the limitations, the methods used in the present study were the recommended methods to measure the indicators, which are used in monitoring and evaluating IDD control programs. For impact indicators, WHOIUNICEFIICCIDD (2001) indicates that goitre assessment by palpation or ultrasound remains a component of surveys to establish the baseline severity of IDD. Neonatal TSH may playa role if a country already has in place a screening program for hypothyroidism. 5.3 mE SELECTED SAMPLE Primary school children were selected as a target group based on international recommendations. They are considered a convenient test group because they are accessible, reflect the current status of iodine nutrition in the community and are a major priority for prompt correction ofIDD (Dunn & Van der Haar, 1990, p.24). A potential disadvantage to the use of this group is that children from the most disadvantaged communities may not attend school (Department of Health, South Africa, 2000). For this reason, the WHOIUNICEFIICCIDD (2001) has indicated that if the proportion of children attending school is less than 50 percent, school children may not be a representative group. The government of Lesotho introduced free primary education in 2000 and this increased school attendance from 67 percent (in 1999) to 89 percent (Ministry of Education, 2002) hence the present study was school based. The preferred group for IDD surveillance is, however, school children aged 6 to 12 years (WHOIUNICEFIICCIDD, 2001) or optionally 8 to 10 years (Sullivan et al., 2000, p.3). Based on these international recommendations children aged 8 to 12 years were the target group in the present study. Children aged 8 years rather than 6 years 133 were selected in order to eliminate measurement errors as it has been stated that the smaller the child, the smaller the thyroid and the more difficult it is to perform palpation accurately (WHOIUNICEFIICCIDD,2001). Women of childbearing age were also selected in the present study because it has been shown that pregnant and lactating women are of concern during IDD surveillance (WHOIUNICEFIICCIDD,2001). In particular, pregnant women are a prime target group for IDD control activities because they are especially sensitive to marginal iodine deficiency and their iodine status is crucial because of the susceptibility of the developing foetus to IDD (Amoa & Rubiang, 2000). Also, goitrogenesis occurring in both the mother and foetus can be directly correlated to the degree of iodine restriction of the mother (Glinoer & Delange, 2000). Therefore, when iodine supplementation is provided early during pregnancy and maintained throughout, it allows for the correction and almost complete prevention of both maternal and foetal goitrogenesis. However, the total number of pregnant women in the present study was small (64). The results obtained are therefore not representative of the situation in Lesotho, but nevertheless provide some indication of the iodine status in pregnant women. A survey of iodine nutrition in pregnant women to prevent the occasional risk of intellectual impairment should be considered in future studies. Iodine is essential for women of childbearing age because the damage done to the brain in early pregnancy can occur before the woman is even aware that she is pregnant (WHO, 1995). Therefore screening women aged 15 to 44 years provides an opportunity to establish the iodine status of a group that is particularly crucial because of the susceptibility of the developing foetus to iodine deficiency. Women aged between 15 to 30 years were, however, selected in this study based on the fact that, after age 30, goitre rates are no longer reliable indicators of current iodine intake (WHOIUNICEFIICCIDD, 2001). The primary school children and the women of child bearing age were both taken as the study target groups because in Lesotho, school children receive lunch at school through various feeding programs (Ministry of Education, 2002). It has been indicated that if school children have diets that are significantly different from those of adults in the household, there is a 134 necessity to survey both school children and women (Sullivan et aI., 2000, p.3). This is due to the fact that if school children receive meals through their school, their dietary intake of iodine may differ from women of childbearing age whose primary source of food is from the home. Ifonly one nationally representative survey is needed, a single 30-cluster survey at the national level can be performed, and within each cluster, it is recommended that 30 urine specimens be collected (Sullivan et al., 2000, p.12). Based on these recommendations 31 clusters were included in the survey, and in each cluster 30 urine samples were collected from the selected school children and women. The same children and women were also palpated and 30 salt samples were collected from the women. At entry point level, 3 salt samples were not collected (107 instead of 110 salt samples were collected). This is because salt samples did not pass through the entry points every day, therefore at the Maseru border post, to avoid spending more than enough time, only 47 salt samples were collected instead of 50. The identification numbers of some of the collected urine samples were duplicated making it impossible to identify the samples. Out of 1860 urine samples collected, 24 (18 for children and 6 for women) were not included for analysis. Also, out of 930 data sheets for the children, 3 were discarded because the recorded ages were not within the recommendation. It is therefore suggested that during the study, field workers should be identified and be given the task of collecting salt at the border gate only from the first day of data collection. It is also suggested that when the sample size is large, at least two people should recheck (after they have been checked by the supervisors) the samples and questionnaires for proper labeling and recording. However, the response rate was high enough (more than 98%) to draw valid conclusions and make recommendations based on the findings. 5.4 SALT IODISATION The median iodine concentration of salt at the point of entry of 36.2ppm (ranging from 30.5ppm to 55.4ppm in the different entry points) (p=0.024) is lower than the legal limit of 40ppm to 60ppm specified in the universal salt iodisation legislation for Lesotho. Only 25.2 percent complied with the legal requirements. Lesotho does not produce salt and almost all of the salt entering the country comes from South Africa where it is obtained from production 135 sites and wholesalers. A minimal loss of iodine is expected to occur from producers and wholesalers in South Africa to entry points in Lesotho. This is based on the fact that a study in India showed that small iodine losses of 9 to 10 percent occurred within 15 to 20 days after packaging in polythene bags where after the iodine content remained constant for 300 days (Chauhan et al., 1992). This initial loss of iodine is due to partial draining of iodised brine adhering to the crystal surface of salt crystals and then sticking to sides of the polythene bags. Many studies have also shown that KI03, which is used to iodise salt in South Africa, is more stable than KI. Therefore the low mean iodine concentration obtained at entry point level shows under-iodisation of salt by the producers. Similar results confirming under- iodisation were obtained in South Africa where the mean iodine concentration of fine and coarse salt at the production site was 30ppm, which ranged from 1 to 55 ppm and only 25.6 percent of producer's salt complied with the legal requirement of 40 to 60ppm of iodine (Jooste, 2001). At retail level, 33.3 percent of the salt samples complied with the legal requirements of 40 to 60ppm of iodine in salt, which is low but higher than at entry point level. Also, the median iodine concentration of 37.3ppm (ranging from 12.4-50.2ppm in the different districts) (p=0.010) was lower than the legal specifications of iodisation at 40 to 60ppm and slightly higher than at entry point level. This is possibly due to the cross-sectional design of the sampling frame at the different levels, and to the very large differences between the minimum and the maximum content of iodine within and between the brands. At entry point level, the iodine content between different brands ranged from only 19.7ppm to 56.3ppm while at retail level the range was 7.2ppm to 152.8ppm, which is very wide. A recent study in Lesotho also indicated a variation of 9 to 76ppm among the brands and 12 to 76ppm within the brands at retail level (Sebotsa et al., 2002). This variation is expected at household level where there are different storage conditions. At retail level, the large variation implies non-uniformity in salt iodisation. The median iodine concentration in household salt of38.5ppm (ranging from 29.2-43.2ppm in the different districts) was slightly higher than at retail level. These findings were not expected because some loss of iodine occurs during distribution between the retailer and the household and through different storage conditions at household level. In Tanzania, large iodine losses 136 were found to have occurred during distribution (Sundqvist et al., 1998). Also, a recent study indicated that most households in Lesotho store salt in uncovered containers such as bottles, cups, mugs and tins thus exposing salt to high temperatures, moisture and heat (Sebotsa et al., 2002). The moisture content of salt, impurities in the salt, atmospheric humidity, light and heat affect the stability of iodised salt (Ranganathan & Rao, 1986). A large variation in the iodine concentration of salt (0-686.5ppm) at household level implies both non-uniformity in salt iodisation at the production site and the different storage conditions of salt by households. Similarly, a quantitative study conducted in the country indicated a variation in iodine levels among brands ranging from 0 to 97ppm and within brands ranging from 7 to 97ppm at household level (Sebotsa et al., 2002). Other similar studies have also shown large variations in iodine levels, for example in Kenya the iodine content for the Kensalt brand ranged from 6.2 to 386.9mg/kg (Muture & Wainaina, 1994). In South Africa there was iodine content range of 7ppm to 40 ppm within brands and 0 to 80ppm between brands (Jooste et al., 1998). Although the median and individual iodine levels varied in the present study, the high values did not reach potentially toxic levels and therefore did not pose a public health threat. With the daily per capita salt intake of 3 to 10grams per day (Bureau of Statistics, 2001) the mean iodine concentration at household level is equivalent to a mean daily iodine intake of 135.9Ilg to 4531lg. This mean iodine appears to be safe when considering the expected iodine losses of 20 percent during the preparation of food (WHO, 1996). High levels of iodine intake, particularly during the introduction of a salt iodisation program, increase the risk of adverse effects. The most common serious complication observed in areas of endemic goitre during salt iodisation is a transient increase in IllI (Stanbury et al., 1998). For example, the introduction of iodised salt in Zimbabwe doubled the incidence of IIH during the first 1 to 2 years of the program (Todd et ai, 1995). However, the benefits of correcting iodine deficiency through salt iodisation far outweigh the risk ofIllI (Baltisberger et al., 1995; Delange, 1998). The median iodine concentration in the Lowlands (37.3ppm at retail level and 40.2ppm at household level) (p=0.045) was higher than that in the Mountains (28.3ppm at retail level and 137 33.1ppm at household level) (pPEND1X3: The Lesotho legislation OIi universal salt iodisation L£SOTHO LESOTHO Government Gazette Extraordinary Vol. XLIV Wednesday - 10tb March, 1999 No.16 CONTENTS No. LEGAL NOTICES 13 Lesotho Iodization Regula.tion. 1999 . L.i)"'1'-' 14 Medical, Dental and Pharmacy (Decrees) . 453 (Amendment) Regulation, 1999 15 Lesotho Fund for Community Development Notice, 1999 454 16 Lesotho Fund for Community Development Regulations ... 455 1999 17 Declaration of a selected Development Area (Plot i'T'J... . .... 464 No. Misc Plan 1/99 Phomolong Maseru South Urban Area) Notice, 1999 . Published by the Aurhority of His Majesty the King Price: 90 Lisente 195 LEGAL NOTICE NO. 13 of 1999 Lesotho Iodization Regulations, 1999 Pursuant. to section 71 of the Public Health Order 1970 I, I, VO\"A BUL-\.NE Minister of Heal'h, make the following Regulations:- Citation and commencement 1. These Regulations may be cited as Lesotho Salt Iodization Regulations, 1999, and shall come into operation on the date of publication in the Gazette. Interpretation In these Regulations, unless the context requires otherwise, "food grade salt" means salt containing not less than 97% crystalline sodium chloride on a dry matter basis, including table salt and coarse salt; "impermeable packaging material" means material which may consist of one or more of the following substances: low density polyethylene, high polyethylene, woven polypropylene or similar materials, and includes polyccated cardboard; "iodated salt" means food grade salt or other salt intended for human and animal consumption to which between 40 and 60 ppm (mg/kg) iodine in the form (I potassium iodate has been added: "low sedn m salt" means salt containing Jess than 67% sodium chloride; "the Orde!" means the Pubhc Health Order, 1970, Order No. 12 of 1970, and any expression to which a meaning has been assigned in the Order shall bear that meaning; "table salt" means salt that contains no more than 4% moisture and 40-60 ppm (rng/l g) fluoride and not less than 98.4% sodium chloride in its water free state. Requirements , .-\ manufact.ircr shall ensure that- (a) taco grade salt or other salt intended for human or animal consumption which is imported into Lesotho shall contain between 40 and 60 ppm (mg/kg) iodine and labeled "iodated salt"; (b) iodated salt is to be packed in sealed impermeable packaging material with a lining of high density polypropylene; Cc) the care of iodation is to be indicated en the bbclot the product together witn other information such ns lot or batch number. manufacture date, cxr.iration date of the SJ]t and net weight thereto. {:Indom check tests 1) Health Inspectors shall conduct rnd administer random check tests at retail 196 level to monitor salt iodine quality and levels. 2) Customs and Excise officials shall conduct random check tests at all ports of entry into Lesotho to morutor salt iodine levels on all imported salt. Offences 5. (1) 1\0 person shall - (a) import into Lesotho; or (b) sell, food grade or other salt intended for human or animal consumption unless iodine has been added thereto. (2) A person who contravenes the provisions of sub-regulation (1) commits an offence and is liable on conviction to a fine not exceeding one thousand maloti or imprisonment for a period not exceeding one year, or both fine and imprisonment. (3) In addition to a fine or imprisonment imposed under sub-regulation (2), the 1:-1ealth :(nspectors shall confiscate such salt. E6.xemptiTonhsese Regulations shall not apply to food grade salt or other salt intended [or- (a) use in the mmmfacture of compound food stuffs which is packed in bags of 20 kg or more and labeled "non-iodated salt"; or eb) (:xperimenting purposes DATED: V. Bulane Minister of Health NOTE 1. Order :\0.12 of 1970 " 197 APPENDIX 4: The legislation on salt iodisation in South Af r ica Act 54 of 1972 G.N.R.996/1995 FOODSTUFFS, COMESTIC~ AND DISINFECTANTS REQULATJONS 7 July 1995 No. R.996: REGULATIONS RELATING TO SALT Th~ Minister of Health has, in terms of section 15 (1) of the Foodstuffs, Cosmetics and Dis infectants Act, 1972 (Act No. 54 of 1972), made the regulations in the schedule. SCHEDULE Definitions I. h these regulations "the Act" means the Foodstuffs, Cosmetics and Disinfectants Act 1972 (Act No. 54 Jf 1972), and any expression to which a meaning has been assigned in the Act shall bear that meaning and, unless the context indicates otherwise - "food grade salt' means salt containing not less than 97% crystalline sodium chloride on a dry matter basis, including table salt; "impermeable packaging material' means material which may consist of one or more of the following substances; Low density polyethylene, high density polyethylene, woven polypropylene or similar materials, and includes polycoated c 1 rdboard; " iodated salt' means food grade salt or other salt intended for use in or on foodstuffs to which between 40 and 60ppm (mg/kg) iodine in the form of potassium iodate has been added; (, low sodium salt' means salt containing less than 67% sodiumchloride; and ," table salt" .means salt that contains no more than 4% moisture and 50 ppm (mg/kg) fluoride and not less than 98,4% crystalline sodium chloride in its water-free state. Requirements 2. (I) No person shall sell food grade salt or other salt intended for use in or on foodstuffs unless iodine has been added thereto. (2) Food grade salt or other salt intended for use in or on foodstuffs which is imported shall contain between 40 and 60 ppm (mg/kg) iodine on entering the Republic of South Africa. (3) Food grade salt or other salt intended for use in or on foodstuffs which is exported from the Republic of South Africa may contain more than 60ppm (mg/kg) iodine. (4) Iodated salt shall be packed in sealed impermeable packaging material (5) The label of iodated salt shall contain the word "iodated salt" as part of the name of the product. (6) Wherever possible the date of iodation shall be indicated on the label of the product. 198 Act 54 of 1972 G.N.R.996/1995 FOODSTUFFS, COSMETICS AND DlSINFECTANTS REGULATIONS Exemptions 3. These regulations shall not apply to__ (a) food grade salt or other salt intended for use In the manufacture of compound foodstuffs which is packed in bags of20 kg or more and which is labeled "non - iodated salt"; . (b) salt available at pharmacies in packages of 1kg or less which are labeled "non - iodated salt "; and © low sodium salt as defined in regulation 1. Repeal 4. Regulation 41 (1) to (10) of the regulations promulgated under the repealed Foods Drugs and Disinfectants Act. 1929 (Act No. 13 of 1929), and published under Govern.nent Notice Nol R.2519 of I 0 December 1954, as amended by Govenllnent Notices Nos. 1618 of5 October 1962 and R295 of 4 March 1966, is hereby repealed. Comm('ncerncnt 5. These regulations shall come into operation on J December 1995. 199 APPENDIX 5: List of villages/clusters and borde.' posts included in the study RURAL VILLAGES DISTRICT ZONE CLUSTER VILLAGE BUTHABUTHE FOOTHilL 0] .31 BOIKETSISO .. DlSTRICT ZONE CLUSTER V1LLAGE 08.34 HAMPSHE , 11.27 HARAMOLOI LOWLAND ,*~_6 HALECHESA , 1LER-m-E ---,.--FOOTHILL 06_.2__J___ L-H-.A MALEFANE-- DI~;TR1CT ZONE CLUSTER VILLAGE ----- J 8.3] HA MALEFETSANE BEREA -LOWLAND 21.25 HA FUSI FOOTHILL 16.37 SETORONG(SEKUTUNG) .'--. Dl~;TRICT ZONE CLUSTER VILLAGE 29.27 LERALLENG -- LOWLAND 32.J6 HANQOSA 34.23 KOLBERE+ MASERU FOOTHILL LEHLAKENG -- 37.40 HANCHAKE MOUNTAll'· 34.15 LIKOTOPONG - {PSHATLELLA)'-'--- '--. r .-I D1STRlCT ZONE CLUSTER VILLAGE I - 38.4 HAMASOETSA I 40.06 HA RAMOKHELEMAF~rENG LOWLAND 42.28 HAKONOTE , 200 -r DISTRICT ZONE CLUSTER VILLAGE 45.05 HA MOLETSANE LOWLAND MOHALE'S HOEK MOUNTAlN 50.13 HA SEBLLl DISTRlCT ZONE CLUSTER VlLLAGE QUTIllNG MOUNTAIN 55.34 SEKHELE S.RVALLEY 52.16 HALEKETE ---- - DISTRICT ZONE CLUSTER VLLLAGE A'S NEK MOUNTAIN 59.46 LIKONYELENG ,....._- DISTRICT ZONE CLUSTER VIlLGAGE I MOKHOTLONG \.10UNTAlN 65.24 MALINGOANENG 600.30 MATOMANENG THABA- TSEKA MOUNTAIN 62.13 BOKHOASA 201 URBAN ViLLAGES DISTRICT CLUSTER VLLLAGE LERIBE : MAPUTSOE 12.59 HANYENYE DISTRICT CLUSTER VLLLAGES 1---. 23.20 BOCHABELA MASERU 25.30 HA TSOLO 27.03 UPPER THA..\t1AE ~_._'--- 28.06 PHOMOLONG MAFLTENG 44 29 MATHENENG _MO.HALE'S HOEK 1 47. .44 STADllfM AREA List of boarder post/entry points r~tricts Boarder Number of salt samples to I post/entry point be collected I I Maser~ Maseru bridge 50 -'. Lenbc Maputsoe 20 Buthabi.the Monontsa 10 r--:--' Mokhotlong Sani-top 10 Qachasnek Qachasnek 10 Mafeterig Vanrooyen 10 -- 202 APPENDIX G: Data sheets and stickers EVALUATION 01~IDD CONTROL PROGRAM IN LESOTHO 2002 HOUSEHOLD DATA SHEET 1. J nterviewer's code number------------- 001-2 2. Identifica tion numJc:r------------------- 00DD3-6 3. l>istrict--------------·--------------------- 007008 4. Ecological zone-------------------------- 09 5. Cluster number--------------------------- 0010-11 6. Vi Ilage------------------------------- 012 7. l'lame------------··--------- 8. Age 0013-14 9. Pregnant? Yes == J 015 No=~. 10C.oitre grade (observer 1) 016 Il. Goitre grade (observer 2) 017 12S.alt sam ple number---------------------- ODOOOOOI8-24 13B.rand of salt--------------------- .-------- 14T.ype of salt 1. coarse 025 2. fine 15. L'rine samp Ie numb er-------------------- 00000 D 026-32 16U. rine iodine contcnt---------------------- 000033-36 17S.alt iodine contenl------------------------ 000037-40 . I 203 EVALIJATION Of (DO CONTROL PROGRAM IN LESOTHO 2002 SCHOOL DATA SHEET 1. In terviewer's code numbcr--------------- 0 D 1-2 2. Jdentification number-----------------··--- D D D D 3-6 3. Dlstrict··--------------··---------------------- D D 7-8 4. Ecological zone---------------------------- 09 5. Cluster number------------------ .---------- 0 D 10-11 6. School-------------------------------··--t~--- 0 12 7 Na In e--- ---- ---,-- ------ ----- --- - ---------- --- 8. Age DD13-14 9. Cender F = 1 J'\1 = 2 lO. Goitre glade (observer 1) II.Goitre grade (observer 2) 12. Urine sample number- D D DOD 0 D 18-24 13. Urine iodine content-------- D [JD 025-28 204 EVAL1JATI08 OF IDD CONTROL PROGRAM' IN LESOTHO 2002 RETAIL DATA SHEET 1. Sample number-------------------·------- DO[JDDDI-6 2. '0 is tri ct-------------------- ------------- ..-- 007-8 3. Ecological zone ..---- ..-------------------- 09 4. Cl us ter number---- ..-..-------------------- DOlO-II 5. Retailer number-v- ---------------- 012 6. .iJ, and 0:: 'la It------- .....-.------------------- 7. r- 'ype of salt 1. coarse 2. fille 013 8. Salt iodine content--------------· ------ ..-- 000014-17 205 EVALUATION OF JDD CONTROL PROGRAM IN LESOTHO 2002 ENTR Y POINT DATA SHEET 9. Sample number-------------------------- 0001-3 10Border post------------------------------- 004-5 11 Entry point number--------------------- 06 12. Brand of salt------------------- ----------- 13. Type of salt l . coarse [4 2. fine 07 1:,. Sa It iod ine content--------------··--------- o lJ 0 [J8-11 206 Stickera Ior Iabeling of samples at household level _Stickers for salt !:amples (white coloured) Name ofvillage····-·······--· Cluster 1:0-···--····-·······-·· Jd no··--·- .--------- ----------- Age----- ..- .--------- ..---------- Sample 110-------------------- Stickers for urine samples (pink coloured) Name of village--------------- Cluster 110---------------------- Id no---- ..----------------------- Age----------------------------- Sample no--------------------- L----. ~ Stickers for labeling of samples at school level Sticker; for urine sample~: ( ellow coloured) Name of ..;chool-------------- Cluster no-------------------- Id 110---.·. --------------------- Age----· - ..------------------- Gender .. ------- ...----------- Sample IlJ------------------- Stickers for' labeling of samples at retail level Stickers for salt samples (white coloured) Retailer 110---------------------- Cluster 110----------------------- Brand -------------------------- Type---------------------------- Sample 110---------------------- ----.--------------.--.---- Stickers for labeling of samples at entry point level Stickers for salt samples white coloured) Entry point no---------------- Brand ---.------------------- --- Type-- ---------------------- --- Sample 110-------------------- L-- ----------- 207 APPENDIX 7: Questionnaire on programmatic indicators of sustainability A QUE[iTIONNAlRE INDICATING THE PROGRAMATIC INDICATORS 2002 Do any of the following programmatic indicators exist in the country? i. ~n effective, functional national body responsible to the government for the national program for the elimination oflDD. YIN Conlrnents----------------------------------------------------- ..-------------------------------------- -------------------------------------------------------------------------------------------------------- 2. Evidence of political commitment of universal salt iodisation and the elimination J:IDD YIN CO" .nlents----- -------------- ----------------------------------..-------------..-------------- -------- ----_.------------------------------------------------------------------------------------------------- 3. Appointment of a responsible \-xecu tive officer for the lDD elimination program YIN Corrlments---------------------------------··-------------------------------------------------------- ---_ .. _------------------------------------------------------------------------------------------------- 4. Legislation or regulations on universal salt iodisation YIN COl nITIents----- --------.------------ --------------------------. --------------- ---------------------- -----~------_._---------------------------------------------------------------------------------------- 5. Commitment to assessment and reassessment of progress in the elimination of JDD with access to laboratories able to provide accurate data on salt and urinary Iodine YIN Cornments------------------------------------------------------------------------------------------ ---_._----------------------------------~-------------------------------------------------------------- 208 6. A program of public education and social mobilization on the importance ofIDD and the consumption of icdised salt YIN Co In Inen ts->- -- -- --- -- --. - --- -- ----- -- ---- ---- --- ---- --- -- -- ------------ -- ---- -- --- -- -- ----- -------- ----- ..-~----------------------------------------------------------------------------------------------- 7. Regular data on salt iodine at the factory, retail and household level YIN COlTmen ts-··- ..--..--- -- -_..- .---- ----- ------ -..----- ----- -- -- ------------- --------- --- -- ---- --- -------- -----~._--------------------_ .._-------------------------------------------- .._--------------------------- 8. Regular laboratory data on urinary iodine in school aged with appropriate sampling for higher risk areas YIN Co IT tn en ts ---------------- ----- ----- --- --- ----------- --- -- ----- -- ..--- ----- ------- -------- --- --- ----- -_ .. -- ---- - ---- -- ---- -- ------ --- ------ --- -- ---- - _ .. -- -- -------_ .._- .._-_.,- - --- ---- ..---- ---- -- --- -- -- -- - ---- 9. Cooperation from the salt industry in maintenance of quality control YIN COI1U nen ts ---------- -- -- ----- -- ----- ---- -- ------- -- -- --- ..------ ------ -- --- -- ---- --- -- ---- --- -- ------ ----- _. ---------------_ ....._---------------------------------------_ .._------_ ..------------------- .._------ 10. A database for recording of results or regular monitoring procedures, particularly :e'r salt iodine, urinary iodine and if available, neonatal TSH, with mandatory p.iblic reporting. YIN Comments---------------------------------··-------------------------------------------------------- ------------------------------------------------------------------------------------------------------- Adapted from WHO/lNICBF/lCCIDD (2001) 209 I' 'I 1,' l < Y • ..- ...... & ENDIX 8: Method used to determine rb« iodine content of salt I " (EXIJacl from: The lJse ofIodized Salt in the Prevention of Iodine Deficiency Disorders - A handbook of uronitoring and qu lli~y control. New Delhi, UNICEPIROSCA, 11)89) AZ.l Principle The iodmc content in iodized salt contaming potassium iodate is estimated by a process called iodomctric titration. Pre'! iodine reacts with sodium thiosulphate solution as follows: 2 Na2Sp3 + 12 --> 2 Na! + Na2S406 Sodium Iodine Sodium Sodium thiosulphate iodide tetrathionatc Sulphuric acid is . ddcd Ir, il solution of iodized sail liberating iodine, which is titrated with sodium thiosulpha:c. Sterr h is used as an cxtc-nr.l indicator. The potassium iodide solution is added to keep the iodine in the d .ssolvcd state. I. I. A2.2 Preparation of reagents II' Dissolve 1.24 g sodium thiosulphate crystals (Na2S20).5H10) in I L boiled, double-distilled j'1 water. This volume, is sufficient for testing 200 salt samples. Store in a cool, dark place. Properly stored, IIIG solution can l»: kept for It few months. Standardize· he sodium thiosulphate solution every I three months using standard potassium iodate solution. I To 1)0 mi doublc-r'istillcd water add 6.0 1111 concentrated sulphuric acid (H2S04) slowly. Add il oiled, double-distilled ...s.ter to make 100 11.1. This volume is sufficient for 100 salt samples. Store '1 a cool dark place. The iolution may bl! kept indefinitely. 'aution: To avoid violent and dangerous reaction always add the acid t() water, never water to :1 reid! Stir the solution \' IJ le adding. e 3. Potassium iodide (KI, AR) 1.1 Dissolve lOa g Kl in I Litre of double-distilled water. This volume is sufficient for testing 200 'alt samples. Store in a ('oJI, dark place. Properly stored, the solution may be kept for 6 months. r,I 1,1 4. Soluble ChCIIli..:21 starch ,I Dissolve rcngcnt-j.r.rdc sodium chloride (NaCl) crystals in 100 ml boiled, double-distilled water. hile stirring,' add Nae until no more dissolves. Heat the contents of the beaker till excess salt issolves. While cooling the NaCI crystals will form on the sides of the beaker. When it is completely ooied, decant the supernatant into a clean bottle. This can be stored for 3 to 4 weeks. ,I issolve I g of chemical starch in 10 ml boiling double-distilled water. Continue to boil till it " omp\etcly dissolves. Add the saturated NaCI solution to make 100 ml starch solution. This volume . sufficient Ior testing 20 salt samples. Prepare fresh starch solution every day since starch solution '1IIlJot bé stored. " ~... ",'" ....... ,. 210 1------------ -.---- ----.---------.--- ~, . t·} "I~ ; (". - ;. i I "lo '!ilI s~.: r '.'- . I:. :~:;:f]: f.... 'Ot \. L .,~Ii ,.\" A2.3 Laboratory procedure The procedure is as follows: I. Carefully weigh 109 of the salt to be tested; 2, Pour the salt into a 50 ml measuring cylinder; 3. Slowly add boiled, double-distilled water; 4. Shake to dissolve the salt completely; 5. Add more water to make 50 ml; 6. Pour the salt solution (50ml) into a conieal tlask with stopper; 7. Pipelle out I nl: of 2 .ti sulphuric acid and add this to the salt solution; 8. Pipelle out 5 ml of 10% potassium iodide and add this to the salt solution; (Do not pipette acid or KI by mouth!) 9. The solution turns yellow. Close the flask with the stopper and put it in the dark for 10 minutes, A closed box, cupboard or drawer may be used; ol ./ 10. Pour 0.OO5N sodium thiosulphate solution into a burette; ,I,I I II. Adjust the level in the burette to "0"; II 12. After JO minutes, take the flask out of the dark box; 13. Shaking the flask, titrate the solution in the flask with sodium thiosulphate from the burette; 14. Slop titration as soon as the solution turns pale (becomes very light yellow); lo 15. ,Add a few drops (I to 5 ml) of I% starch solution to the flask; ." 16. The solution turns deep purple; 17. Continue titration until the purple coloration disappears and the solution becomes colourless: 18. Note the burette reading: 19. From the attached table, read the iodine content of the sample in parts per million J, I , 1 , I .i I" ,! I I- j ~ (:I1 n ~~j 1'. 'I I 211 A2A RCl'or!ing Iodine testing is easy and takes only about twenty minutes per sample. Maintaining accurate records is as important as the testing itself. The results are to be recorded in a register indicating: .. date of testing . *' sample number, * batch number of the salt, * date of iodization, * source of sample, *' date of sampling, and finally, *' level of iodine il' the sample. Daily reports of the findings are made and the supervisor is to be alerted if the iodine content IS less than the prescribed level. Your report will lead to action to protect the consumer. Delay on your part will delay these actions al d harm the consumer. 0\ list of laboratory equipment and reagents required for analysis of Iodized salt and available as a f~ ndard kit through UNICEF Copenhagen is attached. iIl!, jl ,I. ·1 I I i' I ... 1 I 212 ~----------- Io.a. _ ------------------ ,\" , ,. 'I. .- '! ... ~'" .... _: I·', IODINE CONTENT (IN PARTS l'EI{ MILLION) . ' .Burette , Parts 'peL. ! Reading" , itmiilionJ c, '"J'Readi~g jIllon' F:' 1~ __ ~ 4------- __~I ------4-~----~~~~----~"~'--~~~:~'----'~-~I o 0.0 4.0 42.3 8.0 84.6 0.1 1.1 4.1 43.4 8.1 85.7 0.2 2 1 4,2 44.4 8.2 86.8 0.3 3.2 4.3 45.5 8.3 87.R 0.4 4.3 4.4 46.6 8.4 88.9 0.5 5.3 4.5 47.6 8.5 89.9 0.6 6,3 4.6 48.7 8,6 91.0 0.7 7.4 4.7 49.7 8.7 92.0 1~--~-:_~-----1f------~_:.I; I· ~:~ ~_ ;~:~- __ C--'-_:-:'~----!'-'--~-~-:~----111.0 10.6 5.0 52.9 9.0 95.2 l. i j 1.6 5.1 54.0 9.1 96.3 l.2 12.7 I 5.2 55.0 9.2 97.3 1.3 13.8 5.3 56.1 9.3 98.4 lA 14S 5.4 57.1 YA 99.5 :.5 15.9 5.5 5S.2 9.5 100.5 I..J 16.9 5.6 59.2 9.6 101.6 I 7 18.0 5.7 60.3 9.7 102.6 1.8 19.0 ~ 5.8 61.4 'J.8 J03.7 I 1.9 20.1 5.9 62.4 9.9 104.7 I_. 1-- -11 ------I--·------ilt--------j------......jl2.0 21.2 I 6.0 63.52.1 22.2 6.1 64.5 2.2 23.3 6.2 65.6 2.3 24.3 I 6..3 66.7 2.4 25.4 6.4 67.7 2.5 26.5 6.5· 68.8 2.6 27.5 l 6.6 69.8 .t 2.7 2R.6 6.7 70.9 • 2.8 2'.1.6 e.a 71.9 2.9 30.7 6.9 73.0 1~-------1--------!1 ---it-------~------ll 3,0 31.7 I 7.0 74.1 3.1 3H 3.2 33.9 i 3.3 34.9 3.4 36.(1 3.5 37.0 3.6 I38.1 ' II 3.7 39.1 II 'II 3.8 40.2 I1 3.9lk_==~=, -L_=:--4l.3 =JL=. =--=========~== ... 213 APPENDIX 9: Data collection guide and supervisors' checklist DATA COLLECTION GUIDE (For all field workers) HOUSEHOLD LEVEL (30 salt samples and 30 urine samples per cluster) 1. Report yourself to the chief 2. Identify the center of the village 3. Spin a bottle and take a direction of the top of the bottle 4. Then count the number of houses in that line from the center to the edge and choose one bouse at random as the starting point 5. Visit each household in that direction. If the age of a woman is older than 30 or younger than 15 go to the next household 6. Ifthere are more than one women between the age 15 and 30 choose one woman at random for urine sample and palpation (Labell piece of paper and put it together with unlabelled paper in a tin ask the women to pick up the papers. The woman with a labeled paper is the one to be included in the study) 7. In each household explain briefly the purpose and procedures of the study, hand in the consent form and explain where necessary. Collect the form after it has been signed 8. Assess for exclusion criteria (This is done only by the nurses) 9. Palpate the woman according to the standardized procedure (This is done only by the nutritionists) and record the information in the household data sheet 10. Hand in the bottle and ask for urine sample (ask the woman to half fill the bottle). Check if the bottle is properly closed, label the bottle and record in tile household data sheet 11. Put bottle of urine in the cooler bag (do not expose urine sample to direct sunlight). Pack the bottles in an upright position 12. Ask for salt used in the household, mix the salt and put three to four teaspoons in the plastic bag. Ensure that the plastic is tightly closed. Label the sample using the appropriate sticker and record in the household data sheet (do not expose salt sample to direct sunlight) 13. Thank the woman for her corporation and participation and inform her about the fe ed back. SCHOOL LEVEL (30 urine samples per cluster) 1. Report to the principal 2. Ask for children aged 8 to 12 years and for assistance from class teachers 3. Explain the purpose and procedure of the study and collect the previously given consent forms (before data collection day) 4. Assess for exclusion criteria (This is done only by the nurses) 5. Separate children by gender 214 6. Gi ve all the chi Idren numbered pieces of paper and put duplicates in the two tins- one for girls and the other for boys 7. Mix and pick up 15 pieces of paper from each tin and call the numbers 8. Palpate the selected children using the standardized procedure (This is done only by the nutritionists) and record in the school data sheet. Give the selected children plastic bottles and ask for urine sample (ask the children to half fill the bottle). Check if the bottle is properly closed. Label the bottle and record in the school data sheet 9. Put the urine sample in the cooier bag (do not expose urine sample to direct sunlight). Pack the bottles in an upright position. l O. Thank the teachers and children for their assistance, corporation and participation and inform them about the feedback RET AlL LEVEL (6 salt samples / cluster) 1. Ask the chief and write the names of all the retailers on the pieces of paper and put in á tin. Mix and ask the chief to pick two pieces. Then visit the selected retailers 2. Purchase three different brands of salt available in the first shop 3. Co to the second shop and purchase again three brands of salt not available in the first shop or otherwise purchase any brands available 4. 1abel the samples and record in the consolidated retail cluster data sheet ENTRY LEVEL (minimum of lOsalt samples. *check entry point list) J. Report to the head of Customs office and ask for assistance 2. Purchase "if necessary" different brands from the first vehicle 3. Purchase different brands from the second vehicle until you have collected enough. Label the samples and record in the entry point data sheet 215 Checklist for supervisors (for each duster) 1. E;1.5Ure that you have enough equipment every morning 2. Check that samples are labeled correctly and correspond with the data sheet after each field visit 3. After each field visit ensure that urine samples are refrigerated in the laboratory at the hospital and salt samples are packed in boxes l)istrict------------------------------- Eco logica I zone--------------------- C Ius ter n0-------- ------ -------------- Village- ---------------------- ..------- Schoo 1-·-- ----- --------------. -- ..----- Number of salt samples from household level---------------- Number of salt samples from retaillevel------------------- Number of salt samples from entry point~----------------- Total number of salt samples --------------------------- Number of urine samples from pregnant women------------- Number of urine samples from other womcfI----------------- Number af urine samples from school children-------------- Total number of urine samples collected---------------------- Are all samples labeled? Yes / No Is the expected number of samples collected? Yes/No 216 lf no wha t action has been taken--------------------------------------------------- Do information 011 the sticker correspond with data sheet? Yes / No If no whit action has been taken------------------------------------------------------------------- Con1ment'i------"------------··--:.------------------------------------------------------------------------ ----- ----- ...- ._ ----_ .._------ --- -_ ...--- --- ---- ------- --- ---- --------------- --- ------------_ ... -- ---- --------- ---- ---------_ ..- ~-_..._-_ ..------_ .....--_.~......._------------------------------------------------------_ .. ---------------- Name of supervisor------------------------------··- Signature of supervisor---------------------------- Date-----··-------------------------------------------- 217 , ft 1 . THE TASKS OF THE RESEARCHER The task 0 f the researcher was to plan and organize for the study, train and supervise the field workers ard compile a report. A brief description of the task of the researcher is as follows: (i) Planning and organising • Using the population census '~ata obtained from Bereau of Statistics, the researcher selected the number of clusters ill each district and ecological zones. The researcher explained the selection methodology to the Statistitian who selected the villages. o Plan the evaluation and monitoring of the salt iodisation program co Collect and review relevant information. • Write the proposal to UNICEF and send it through FNCO. fil Organize a meeting with the IDD control and micronutrient task forces for briefing and support. • Write lettors to Ministry of Education, Local government and Customs for approval of the study. • Collect all materials to be used in the study. and arrange with laboratories in all the districts for storage of urine samples until collected for forwarding to central laboratory. If; Develop data sheets, stickers for labelling (Appendix 6), a questionnaire (Appendix 7), data collection guidelines and supervisors' checklist (Appendix 9) 4 J.ec::uit the 24 field workers. • Al range for a: pilot study and compile information and recommendations obtained. • Develop and send Gonsent forms to selected schools. • Arrange for transport of urine and salt samples from Maseru to Cape Town for chemical analysis. • Develop ê·. questionnaire on programmatic indicators and ask the Director of FNCO to complete the questionnaire. Interview format used. 218 (ii) Training, and supervising • Train field workers using the data collection guide (Appendix 9) on random sampling, urine and salt sample collection, labelling and recording of information on the data sheets and stickers. • Teach supervisors (nutritionists) how to supervise during field work, follow the data collection guidelines and till in the supervisors' checklist. o Supervise each team alternatively to ensure that both fieldworkers and supervisors are doing the work efficiently. During this supervisory visits, the researcher also collected data • Check all the samples and data sheets during field visits (alternative supervisory visits) and, on arrival from the field, take to the central point for completion. • Pack urine and salt samples in batches for transport to Cape Town. Spend a week in Cape Town involved in chemical analysis of the samples · " 219 """~ " " '". - , APPENDIX 10: Method used to determine the iodine content of urine samples IC method described in this Appendix is.to be published in a report based on ajoint HO/UNICEF/ICCrDD cor,sultationAssessment of the Iodine Deficiency Disorders and their imination: A Guide/or Programme Managers which was held in Geneva, May, 1999 Method A.,using ammonium persullate -lCCLDD Recommended Method 'ineiole rine is digested with ammonium persulfatc. iodide is catalyst in the reduction of eerie ammonium r Ifatc (yellow) to eerous form (colorless), and is detected by rate of color disappearance (Sandell- olthoff reaction). bujOJUcnt eating block (vented fume hood not necessary), colorimeter, thermometer, test tubes (13 x 100 mm) agent flasks and boul es, pipettes, balance. ~gents Ammonium persullate (analytical grade) As20) Nael 112S04 Cc(Nl-4)4( S04)4'2Hi) Deionized I-ha Kla) blutions Anunoruum persulfate, 1.0 M. Dissolve 114.1 g H2N20gSz in 1:120 then make up to 500 ml Witll1120. Store away from Iig b.t. StabJe for at least one month. 5 N H S04: Slowly add 139 ml eoncenlrated (36~) H2S04 to about 700 ml deionized water (careful2 _ this generates heatl) and when cool, adjust with deionized water to a final volume of I litre. Arsenious acid solution. lo a 2000 ml Erlenmeyer flask, place 20 g AszO) and 50 g NaCl, then slowly add 400 ml 5 ~ H2S04. Add water to about I litre, heat gently to dissolve, cool to room temperature, dilute with water to 2 litres, filter, and store in dark bottle away from light at room temperature. The solution is stable fur months. Cerie ammonium rulfate solution. Dissolve 48 g eerie ammonium sulfate in 1 litre 3.5 ~ l-hS04 (3.5 N H S04 is made by slowly adding 97 ml eoncentrared (36 W H2S04 to about 800 ml deionized2 , water (care/ill - this generates heat!), and when cool, adjusting with deionized water to final volwne of 1 litre). Store in a dark bottle away from light at room temperature. The solution is stable for months. Standard iodine SI )jution, I ug iodine/ml (7.9 1lO101l1): Dissolve 0.168 mg KlO) in deionized water to a final volume of 100 inl.' (1.68 mg KlO) contains 1.0 mg iodine; KlO) is preferred over Kl because . )~ is more stable, but Kl has been used by some laboratories without apparent problems). It may be more convenient to make a more concentrated solution, e.g., 10 or 100 mg iodine/ml, then dilute to I ug/rnl. Store in a dark bottle. The solution is stable for months. Useful standards are 20,50, 100, 150, 200, and 300 f.--glL. 220 ~~E.C;'l~~.~. ~~;: . - _.~. _.;1 ,~:,,m. -;~--,inu~~- k~~-,~.-,.,.!.l",*,l,i.~1U\W :4WS~Ur£llbU+,,~jq>fi,)l,' -:6'- .......... :"'"~.~!"''-'~....'".'.:."c • -- _ -. ~_.- • ····,.-'rf ! 'cdur~ Mix urine lo suspend sediment. Pipette 250 )J.l of each urine sample into a 13 x 100 mm test tube. Pipette each iodine standard into a test 1111}<.:then add I !2() as needed to make a final vol urne of 250 Ill. Duplicate iodine standards and a set or internal unnc i.tandards should be included in each assay. i\.dd I ml. L.O M ammonium persullate to each tube. Ileal all tubes for 60 minutes at 100" C. Cool tubes to room t'~11pcrature. t Add 2.5 ml arsenious acid solution. Mix by inversion or vortex. Let stand for 15 minutes. 1 Add 300 III of eerie ammonium sulfate solution to each tube (quickly mixing) at 15-30 second ~ intervals between successive lubes. A stopwatch should be used for this. With practice a 15 second interval is convenient. Allow to sit at room .ernperature. Exactly 30 minutes after addition of eerie ammonium sulfate to the 1 I' first tube, read its absorbance at420 nm and read successive tubes at the same interval used lo add the ,! eerie ammonium sulfate. 1 ~ !' ulation of results struct a standard curve on graph paper by plotting iodine concentration of each standard on the issa against its optical density at 405 ug/L (OD40S) on the ordinale. I, ! ! ~.~ This rs modified fron former Method A by substituting ammonium persullate Ior chloric acid (more ! tOXIC) as digestani. ii Since the digestion proccdure has no specific end point, it is essential to run blanks and standards I witll each assay lo allow (or variations in heating, time, etc. I The exact tcmpcraturr , heating time, and cooling time may vary. However, within each assay, the intcrval bctwcc n thc tl1lC of addition of eerie ammonium sulfate and the time of the reading must be t''1C same :k-r ill: surnpk s, standards, and blanks. Will). the lougor eerie z~llnonjUtl1 sulfate incubation and with 15 second interval additions orCAS, up to ~20 tubes can be ll:ui in a single assay. Ihc volumes and proportions of sample and reagents can be varied to achieve different concentrations Jr a different curve shape, if conditions warrant it. If different tube sizes are used, corresponding size holes in the heating block arc also needed. Ir necessary, this method could probably be applied without a heating block, using a water, oil, or ~ánd bath, but this is Dot recommended. It is essential that all tubes are uniformly heated and that the cmpcraturc be constant within the range Jescribed above. fest tubes can be reused if they are carefully washed to eliminate any iodine contamination. Various steps of this procedure are suitable for automation. For example, the colorimetric readings pan be done ill microtiter plates with a scanner, and the standard curves plotted and read on a simple ~esk computer. Terences between the urinary iodine method in this document and the ICCIDD method following tiou of Iodine deficiency Disorders control program ' h We refer to your letter dated S' of January 2002. As Local gavemmenl we ensure the well being of the public and therefore support ail activities working towards this goal. We therefore approve that the task forces conduct the mentioned study and guarantee you will get all the support you need from us. We wish you all the best. 228 G. P. 139 SAVINGRAM FROM: DIRECTOR EDUCATION TO: DURECTOR: FNCO -. SIGNJCJ>: (Full Sit~m NAME: M.THULO (Mrs) FaENO .. (Typed) (Receiving Min./Dept.) DATE: 8 JANUARY 2002 RE: EVALUATION OF IODINE DEFICIENCY DISORDERS CONTROL PROGRAM With reference to your letter dated 5 January 2002. Education office approves the conduction of such study, which will hopefully benefit the country. Our office will offer you support throughout the whole exercise .: 229 .r, ,,,,,!:II G. P. 139 SAVINGRAM FROM: DIRECfOR CUSTOMS TO: DIRECTOR: FNCO NAME: S.TSOEU (MR.) FaE NO . (Typed)! (Receiving Min./Dept.) DATE: 10 JANUARY;t002 RE: Evaluation of Iodine deficiency Disorders control program Please refer to your letter dated 5th January 2002. We are pleased that you have planned to conduct the evaluation of the salt iodisation program. Customs approves such activity and will ensure that you receive the support from the customs officers. We appreciate all your efforts to plan and implement activities, which are of benefit lo the population in Lesotho. 230 )" ~ :.:. _* ,111.;"" l~ " SUMMARY OF TIlE THESIS The broad range of disorders in a population caused by an inadequate dietary supply of iodine was denoted as iodine deficiency disorders (JDD), which include endemic goitre, hypothyroidism, cretinism and congenital anomalies. When iodine deficiency is widespread, mental retardation impedes national human resource development. Despite the known effective control measures, 130 WHO member states have a significant JDD problem. Severe to mild JDD have been reported in Lesotho since 1960. The most cost-effective and sustainable intervention to eliminate JDD is the iodisation of all edible salt. However, several countries with long standing salt iodisation programs have reported declining levels of urinary iodine. In Lesotho, the legislation on universal salt iodisation was promulgated in 2000. Therefore the aim of the study was to evaluate the salt iodisation program in Lesotho in terms of process, impact and sustainability indicators. A 30 cluster national survey was conducted where the proportion to population size method was administered. In each cluster, 30 women aged 15 to 30 years, and 30 primary school children aged 8 to 12 years, were randomly selected. The selected women and children were palpated and thyroid size graded according to WHOIUNICEFIICCJDD (2001) criteria and urine samples collected. 30 salt samples were collected from these selected women, 6 samples from 2 randomly selected retailers in each cluster, and 107 samples collected from all the commercial entry points in the country. The salt samples were analysed using the iodometric titration method while urine samples were analysed using the method using ammonium persulfate according to WHOIUNICEFIICCJDD (2001) recommendations. This analysis was performed at the Medical Research Council in Cape Town (South Africa) where the Coefficient of Variation for urinary iodine analysis was 7.7 at a concentration of IOug/l, and was 2.7 at a concentration of 70ppm for titration method of salt analysis. The statistical analysis was done using the SAS program at the University of the Free State (South Africa). A total of927 children and 930 women who were palpated, and 912 children and 924 women who gave urine samples, were included in the analysis of the results. 930 salt samples from 231 household level, 186 from retail level and 107 from entry point level were analysed. 3 salt samples from entry point, 18 and 6 data sheets for urinary iodine of women and children respectively were not included during statistical analysis. The median iodine concentration of salt was 36.2ppm (ranging from 30.5-55.4ppm in the different entry points), 37.3ppm (ranging from 12.4-50.2ppm in the different districts) and 38.5ppm (ranging from 29.2-43.2ppm in the different districts) at entry point, retail level and household level respectively. At household level only 1.6 percent used non iodised salt and 86.9 percent used adequately iodised salt. The analysis of the urine samples showed that the median urinary excretion was 214.7flg/1 (ranging from 62.9flg/1 to 302.6flg/l in the different districts) for the children and 280.1flg/ (ranging from 124.8flg/1 to 381.6flg/l in the different districts) for the women, indicating more than adequate iodine intake according to the WHOIUNICEFIICCIDD (2001) report. The median iodine concentration was higher in boys (219.3flg/l) than in girls (212.6flg/I), higher in the Lowlands (256.0 flg/l in children and 329.9 ug/l in women) than in the Mountains (99.30flg/l for children and 182.6flg/1 in women) and higher in non-pregnant women (283.0 ug/l) than in pregnant women (212.1 ug/l). In the whole country, the prevalence of goitre was 10.7 percent (ranging from 6.6% to 22.6 % in the different district) in children and 19.4 percent (ranging from 6.7% to 36.7% in the different districts) in women, which indicates mild IDD (WHOIUNICEFIICCIDD, 2001). IDD were observed more in females (14.0%) than in males (7.0%) and was less (4.3%) in children aged 8 than in children aged 12 years (12.9%). In women IDD increased with age from the age group of 15 to 19 (17.3%) to the age group of 20 to 25 (22 %) and decreased in the age group of 26 to 30 (18.4%). Similar to urinary iodine results, IDD was observed more in the Mountains (17.7% for women and 18.1% for children) than in the Lowlands (14.3% for women and 6.7% for children). Only the urinary iodine excretion reached the WHOIUNICEFIICCIDD (2001) sustainability goals. At household level, 86.9 percent of the households, which is slightly lower than the recommendation of at least 90 percent, use adequately iodised salt. Out of 10 programmatic indicators of sustainability, only 4 indicators have been attained by the salt iodisation program in Lesotho. According to the WHOIUNICEFIICCIDD (2001) at least 8 of the programmatic indicators should be attained for sustainable elimination ofIDD. 232 The study demonstrates a major achievement in the household use of iodised salt and adequately iodised salt. However, salt is not iodised according to the legislation on universal salt iodisation in Lesotho due to under iodisation and non- uniformity of salt iodisation at the production site. Iodine deficiency has been eliminated as a public health problem in Lesotho and this is due to the introduction of the legislation on universal salt iodisation. This study highlighted the effectiveness of iodised salt in increasing urinary iodine concentration. Iodine deficiency increased with age and was higher in girls than in boys, and higher in the Mountains than in the Lowlands. IDD elimination in Lesotho will be sustainable if more than 90 percent of the households use adequately iodised salt and the programmatic indicators such as commitment to reassessment, political commitment, implementation of social mobilization program and reqular monitoring are achieved by the IDD control task force. The administrative structure and activities of the IDD control task force need to be revised and strengthened for the sustainable elimination ofIDD. The terms of reference of the committee should be revised, budgets for the activities be drawn, new members added and trained and responsibilities given to each member. Awareness campaigns, which will start at policy makers' level, should be initiated. Law enforcement should be an integral part of the salt iodisation program. Effective regular monitoring of salt iodine content at all levels with special attention to iodisation of coarse salt is recommended together with periodic evaluation of the iodisation program. Key words: goitre, urinary iodine concentration, iodine deficiency disorders, salt iodisation, sustainability, monitoring and evaluation 233