Estimating habitual iodine intake and prevalence of inadequacy from spot urine in cross-sectional studies: a modeling analysis to determine the required sample size.

BACKGROUND: The habitual/usual iodine intake and the prevalence of iodine inadequacy may be estimated from spot urinary iodine concentrations in cross-sectional studies by collecting a repeat spot urine in a subgroup of the study population and accounting for within-person variability in iodine intake. However, guidance on the required overall sample size (N) and the replicate rate (n) is lacking. OBJECTIVES: To determine the sample size (N) and replicate rate (n) needed to estimate the prevalence of iodine inadequacy in cross-sectional studies. METHODS: We used data from local observational studies conducted in women 17-49 y old in Switzerland (N = 308), South Africa (N = 154), and Tanzania (N = 190). All participants collected 2 spot urine samples. We calculated the iodine intake using urinary iodine concentrations and accounted for urine volume using urinary creatinine concentration. For each study population, we estimated the habitual iodine intake distribution and determined the prevalence of iodine intake below the average requirement using the Statistical Program to Assess habitual Dietary Exposure (SPADE). We used the obtained model parameters in power analyzes and estimated the prevalence of iodine inadequacy for different sample sizes (N = 400, 600, and 900) and replicate rates (n = 50, 100, 200, 400, 600, and 900). RESULTS: The estimated prevalence (95% CI) of inadequate iodine intake was 21% (15, 28%), 5.1% (1.3, 8.7%), and 8.2% (3.4, 13%) for Swiss, South African, and Tanzanian women, respectively. An N of 400 women, with a repeated measure (n) in 100 women, achieved a satisfactory precision of the prevalence estimate in all study populations. Increasing the replicate rate (n) improved the precision more effectively than increasing the N of the study. CONCLUSIONS: The sample size for cross-sectional studies aiming to assess the prevalence of inadequate iodine intake depend on the expected prevalence, the overall variance in intake, and the study design. However, an N of 400 participants with a repeated measure of 25% may be used as guidance when planning observational studies applying simple random sampling. This trial was registered at clinicaltrials.gov as NCT03731312.

Seasonal effects on urinary iodine concentrations in women of reproductive age: An observational study in Tanzania and South Africa.

BACKGROUND: Iodine intake in populations is usually assessed by measuring urinary iodine concentrations (UICs) in spot samples. Hot climate conditions may reduce urine volume, thus leading to overestimations of UIC and thereby masking inadequate iodine intake. OBJECTIVES: We investigated the effects of season on UICs in 2 populations exposed to high-temperature climates. METHODS: In this observational study, we examined women (18-49 years) in Tanzania (ncold = 206; nhot = 179) and South Africa (ncold = 157; nhot = 126) during cold and hot seasons. From each woman in both seasons, we obtained two 24-hour urine collections and 2 spot urine samples, as well as salt, water, and cow's milk samples. We measured the urine volume, UIC, and urinary creatinine concentration (UCC). The 24-hour urinary iodine excretion (UIE) was calculated and used to estimate the iodine intake. We used linear mixed-effects models to test for differences between seasons. RESULTS: In Tanzanian women, we observed no seasonal effect on the urine volume, 24-hour UIE, 24-hour UIC, spot UIC, spot UIC:UCC ratio, or salt iodine concentration. In South African women, the median 24-hour urine volume was 1.40 L (IQR, 0.96-2.05 L) in the winter and 15% lower in the summer (P < 0.001). The median 24-hour UIE was 184 µg/day (IQR, 109-267 µg/day) in the winter and 34% lower in the summer (P < 0.001), indicating a lower iodine intake. As a result, UICs did not significantly differ between seasons in 24-hour collections and spot samples, whereas the spot UIC:UCC ratio differed by 21% (P < 0.001) and reflected the lower iodine intake. In both study populations, the within- and between-person variabilities in urine volume, 24-hour UICs, and spot UICs were higher than the variability between seasons. CONCLUSIONS: Spot UIC may slightly overestimate the iodine intake in hot temperatures due to concentrated urine, and methods to correct for urine volume may be considered. Local seasonal differences in iodine intakes may also occur in some populations. This trial was registered at http://www.clinicaltrials.gov as NCT03215680.

Tanzania national survey on iodine deficiency: impact after twelve years of salt iodation.

BACKGROUND: In many low-income countries, children are at high risk of iodine deficiency disorders, including brain damage. In the early 1990s, Tanzania, a country that previously suffered from moderate to severe iodine deficiency, adopted universal salt iodation (USI) as an intervention strategy, but its impact remained unknown. METHODS: We report on the first national survey in mainland Tanzania, conducted in 2004 to assess the extent to which iodated salt was used and its apparent impact on the total goitre prevalence (TGP) and urinary iodine concentrations (UIC) among the schoolchildren after USI was initiated. In 2004, a cross-sectional goitre survey was conducted; covering 140,758 schoolchildren aged 6 - 18 years were graded for goitre according to new WHO goitre classification system. Comparisons were made with district surveys conducted throughout most of the country during the 1980s and 90s. 131,941 salt samples from households were tested for iodine using rapid field test kits. UIC was determined spectrophotometrically using the ammonium persulfate digestion method in 4523 sub-sampled children. RESULTS: 83.6% (95% CI: 83.4 - 83.8) of salt samples tested positive for iodine. Whereas the TGP was about 25% on average in the earlier surveys, it was 6.9% (95%CI: 6.8-7.0) in 2004. The TGP for the younger children, 6-9 years old, was 4.2% (95%CI: 4.0-4.4), n = 41,965. In the 27 goitre-endemic districts, TGP decreased from 61% (1980s) to 12.3% (2004). The median UIC was 204 (95% CF: 192-215) microg/L. Only 25% of children had UIC <100 microg/L and 35% were > or = 300 microg/L, indicating low and excess iodine intake, respectively. CONCLUSION: Our study demonstrates a marked improvement in iodine nutrition in Tanzania, twelve years after the initiation of salt iodation programme. The challenge in sustaining IDD elimination in Tanzania is now two-fold: to better reach the areas with low coverage of iodated salt, and to reduce iodine intake in areas where it is excessive. Particular attention is needed in improving quality control at production level and perhaps the national salt iodation regulations may need to be reviewed.

Improved salt iodation methods for small-scale salt producers in low-resource settings in Tanzania.

BACKGROUND: Universal salt iodation will prevent iodine deficiency disorders (IDD). Globally, salt-iodation technologies mostly target large and medium-scale salt-producers. Since most producers in low-income countries are small-scale, we examined and improved the performance of hand and knapsack-sprayers used locally in Tanzania. METHODS: We studied three salt facilities on the Bagamoyo coast, investigating procedures for preparing potassium-iodate solution, salt spraying and mixing. Different concentrations of solution were prepared and tested using different iodation methods, with the aim of attaining correct and homogeneous iodine levels under real-life conditions. Levels achieved by manual mixing were compared to those achieved by machine mixing. RESULTS: The overall median iodation level in samples of salt iodated using previously existing methods was 10.6 ppm (range 1.1 - 110.0 ppm), with much higher levels in the top than the bottom layers of the salt bags, p < 0.0001. Experimentation using knapsack-sprayers and manual mixing led to the reliable achievement of levels (60.9 ppm +/- 7.4) that fell within the recommended range of 40 - 80 ppm. The improved methods yielded homogenous iodine concentrations in all layers of salt-bags (p = 0.58) with 96% of the samples (n = 45) falling within 40 - 80 ppm compared to only 9% (n = 45) before the experiment and training (p < 0.0001). For knapsack-spraying, a machine mixer improved the iodine levels and homogeneity slightly compared to manual mixing (p = 0.05). CONCLUSION: Supervised, standardized salt iodation procedures adapted to local circumstances can yield homogeneous iodine levels within the required range, overcoming a major obstacle to universal salt iodation.

Remaining challenges in Tanzania's efforts to eliminate iodine deficiency.

OBJECTIVE: To determine iodine levels in salt and iodine deficiency prevalence in school-aged children in 16 districts in Tanzania with previous severe iodine deficiency. DESIGN: A cross-sectional study in schoolchildren. Systematic probability sampling was used to select schools and subjects for goitre assessment and urinary iodine determination. SETTING: Sixteen districts randomly selected from the 27 categorised as severely iodine-deficient in Tanzania. SUBJECTS: The study population was primary-school children aged 6-18 years who were examined for goitre prevalence and urinary iodine concentration (UIC). Salt samples from schoolchildren's homes and from shops were tested for iodine content. RESULTS: The study revealed that 83.3% of households (n=21,160) in the surveyed districts used iodised salt. Also, 94% of sampled shops (n=397) sold iodised salt, with a median iodine level of 37.0 ppm (range 4.2-240 ppm). Median UIC in 2089 schoolchildren was 235.0 microg l(-1) and 9.3% had UIC values below 50 microg l(-1). The overall unweighted mean visible and total goitre prevalence was 6.7% and 24.3%, respectively (n=16,222). The age group 6-12 years had the lowest goitre prevalence (3.6% visible and 18.0% total goitre, n=7147). The total goitre prevalence had decreased significantly in all districts from an unweighted mean of 65.4% in the 1980s to 24.3% in 1999 (P<0.05). We believe this difference was also biologically significant. ConclusionThese findings indicate that iodine deficiency is largely eliminated in the 16 districts categorised as severely iodine-deficient in Tanzania, and that the iodine content of salt purchased from shops is highly variable.