The Effects of Iodized Salt on Cognitive Development in Ethiopia
Many school children in Ethiopia and their mothers are known to be iodine deficient. Prevalence in the Amhara region is around 29%. Micronutrient Initiative, a development organization based in Ottawa, plans to help iodize the salt by providing iodization machines and iodine to the salt producers in Lake Afdira where salt is produced and distributed to the population of Ethiopia. Although it is generally assumed that iodine is important for cognitive development, very few studies examining the effects of iodized salt have been conducted. Studies using a single dose of iodine capsules with children 6 to 12 years showed mixed outcomes with approximately 25% yielding positive outcomes for the intervention children. Sixty districts in Amhara will be randomly selected and randomly assigned so that half receive early delivery of iodized salt. Approximately 6200 mothers and their children 6-, 18-, or 60-months old will be recruited from 1-2 villages in each of the 60 districts, with the help of government-paid Health Extension Workers, for a 12-mo longitudinal study starting in May 2011, prior to the introduction of iodized salt. These same mothers and children will be visited 12 months later for repeated measures. Measures include nutritional status such as height and hemoglobin, along with iodine sufficiency (e.g., goitre, urinary iodine, thyroglobulin), and child development (Bayley Scales of Infant and Toddler Development III, Wechsler Preschool and Primary School Intelligence test for older children). Comparisons will be made within and between groups to determine whether iodized salt has an effect on children's mental development.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Study to Measure the Effect of Switching the Salt Supply From Non-iodized to Iodized on Cognitive Development in Ethiopia|
- cognitive development at 6 mo [ Time Frame: 6 months ] [ Designated as safety issue: No ]Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales
- Cognitive development at 18 mo [ Time Frame: 18 months ] [ Designated as safety issue: No ]Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales
- cognitive development at 60 mo [ Time Frame: 60 months ] [ Designated as safety issue: No ]two Wechsler Preschool and Primary School Intelligence subscales plus a School Readiness test
- nutritional status at 6 mo [ Time Frame: 6 months ] [ Designated as safety issue: No ]weight, length/height, iodine and iron status
- nutritional status at 18 mo [ Time Frame: 18 months ] [ Designated as safety issue: No ]weight, length/height, iodine and iron status
- nutritional status at 60 mo [ Time Frame: 60 months ] [ Designated as safety issue: No ]weight, length/height, iodine and iron status
|Study Start Date:||October 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
No Intervention: Comparison group
This arm will use the salt that is on the open market, which is primarily non-iodized salt. Iodized salt may enter in these communities through the normal trade route. No active interference with salt trade will occur in these communities.
Experimental: Early delivery of iodized salt
Iodized salt that is produced nationally for the open market (which meets only about 10% of national needs) will be directed to these communities through the normal trade system or by direct delivery to the communities.
Other: Iodized salt
salt for human consumption is fortified at the national level with iodine. The experimental group will receive iodized salt early. the comparison group will receive it by market forces. presently there is only enough iodized salt to meet 10% of the countries needs, and is targeted mainly to urban areas.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01349634
|Montreal, Quebec, Canada, H3A 2T5|
|Principal Investigator:||Grace S Marquis, PhD||McGill University|
|Principal Investigator:||Frances Aboud, PhD||McGill University|
|Principal Investigator:||Aregash Samuel, MSc||Ethiopian Health and Nutrition Research Institute|