The Effects of Iodized Salt on Cognitive Development in Ethiopia

NCT01349634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5704

Last updated 2016-06-09

No results posted yet for this study

Summary

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.

Conditions

  • Iodine Deficiency
  • Goiter
  • Cretinism

Interventions

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.

Sponsors & Collaborators

  • Micronutrient Initiative

    collaborator OTHER
  • Ethiopian Health and Nutrition Research Institute

    collaborator OTHER
  • McGill University

    lead OTHER

Principal Investigators

  • Grace S Marquis, PhD · McGill University

  • Frances Aboud, PhD · McGill University

  • Aregash Samuel, MSc · Ethiopian Health and Nutrition Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
61 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349634 on ClinicalTrials.gov