- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349634
The Effects of Iodized Salt on Cognitive Development in Ethiopia
A Study to Measure the Effect of Switching the Salt Supply From Non-iodized to Iodized on Cognitive Development in Ethiopia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
MATERIALS AND METHODS Sample size was estimated on the basis of the Bayley Scales of Infant and Toddler Development III (Bayley) where the mean is 100 and the standard deviation is 15. Using an effect size of 0.20 standard deviation, a beta of .05 and power of .80, and accommodating for clustering within villages and attrition, the investigators require a sample size of 800 for each group (intervention and control). Severely anemic children (< 8 mg/L) will be referred for treatment and not included in the study.
In this longitudinal study the investigators will recruit 3200 6-mo old infants and 1600 children from each of two other age groups: 18-, and 60-months (inclusion criteria) and their mothers. The exclusion criteria: severe anemia (hemoglobin < 8g/dL). If children are too disabled to take a cognitive test, this will be noted but no cognitive testing administered.
From six zones around Bahir Dar, the investigators will randomly select 60 districts. Half will be assigned randomly to start receiving iodized salt in July 2011; the other half will receive iodized salt as it becomes available in the market. From each district, 1-2 villages will be randomly selected for recruiting 30 children from each age group. It is assumed that with a pregnancy rate of 3.7%, approximately 166 children are born every year in a village of 4500, and 13 are born every month. So within 3 months, starting in May 2011, 30 children of each age could be recruited.
With the help of Health Extension Workers, trained field workers will identify the participants : children of eligible age. Mothers will provide written consent for themselves and their children to participate.
Mothers will be interviewed at baseline and endline concerning the family's economic and demographic information, child's health and diet, and opportunities for stimulation of children (Home Observation for Measurement of the Environment Inventory; Center for Epidemiologic Studies Depression Scale symptom scores). Children's nutritional status will be measured with a food frequency questionnaire, length/height, weight, blood indicators for thyroid function (thyroglobulin, thyroxin, triiodothyronine) and iron status (hemoglobin, ferritin, soluble transferrin receptor), and inflammation (C-reactive protein), goiter, and urinary iodine. A maximum of 10 mL will be collected for blood by venipuncture. Finally, trained assistants will administer the Bayley Scales of Infant and Toddler Development III (cognitive, language, and fine motor scales) to children under-3 years and two Wechsler Preschool and Primary School Intelligence test subscales and School Readiness test for 60-month olds. Salt will be collected at various places of purchase and in households to test for iodine content (first qualitatively, then quantitatively if iodized) at baseline and at the end of the study. All data collection will be done at home or a convenient site in the village.
Conversion of diet into iodine content will be done based on food composition table. Anthropometric data will be converted to standardized scores using the new World Health Organization reference curves, using World Health Organization's software Anthro v. 2 for children up to 60 months of age.
Analyses will compare the nutritional and developmental outcomes of two groups who differ in iodized salt exposure, covarying confounders such as mother's education, family assets, child's sex, and adjusting for clustering. Developmental scores will be derived for the Bayley subtests, and the Wechsler Preschool and Primary School Intelligence test. These tests typically assign 1 point for every correct answer and 0 points for incorrect answers; the summed continuous scores are then used for analysis. Potential confounds include the Home Observation for Measurement of the Environment Inventory and Center for Epidemiologic Studies Depression Scale symptom scores, which also are calculated as the sum of individual item points. Laboratory analyses will be conducted to determine hemoglobin, ferritin, soluble transferrin receptor, thyroglobulin, thyroxin, and triiodothyronine from blood samples, and iodine excretion from urine samples. Analyses of salt will also indicate whether salt consumed by participants in the intervention districts has the required ppm of iodine and more than salt consumed in control districts. If households in the control sites have higher than expected levels of iodine, this will be recorded and included in the analyses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
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Montreal, Quebec, Canada, H3A 2T5
- McGill University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children within 15 days of 6, 18, and 60 months
Exclusion Criteria:
- severe cognitive impairment so child cannot respond to Bayley Scales of Infant and Toddler Development III test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cognitive development at 6 mo
Time Frame: 6 months
|
Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales
|
6 months
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Cognitive development at 18 mo
Time Frame: 18 months
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Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales
|
18 months
|
cognitive development at 60 mo
Time Frame: 60 months
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two Wechsler Preschool and Primary School Intelligence subscales plus a School Readiness test
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nutritional status at 6 mo
Time Frame: 6 months
|
weight, length/height, iodine and iron status
|
6 months
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nutritional status at 18 mo
Time Frame: 18 months
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weight, length/height, iodine and iron status
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18 months
|
nutritional status at 60 mo
Time Frame: 60 months
|
weight, length/height, iodine and iron status
|
60 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aregash Samuel, MSc, Ethiopian Health and Nutrition Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1152-MCGUNI-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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