The Effects of Iodized Salt on Cognitive Development in Ethiopia

NCT01349634 | Completed

• 1 other identifier: 10-1152-MCGUNI-01
• Study Type: interventional
• Target: 5,704
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

iodine; goiter; cretinism; child nutrition; cognition

Outcome Measures

Primary Outcomes (3)

• cognitive development at 6 mo

  Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales

  6 months

• Cognitive development at 18 mo

  Bayley Scales of Infant and Toddler Development III cognitive, language, and fine motor scales

  18 months

• cognitive development at 60 mo

  two Wechsler Preschool and Primary School Intelligence subscales plus a School Readiness test

  60 months

Secondary Outcomes (3)

• nutritional status at 6 mo

  6 months

• nutritional status at 18 mo

  18 months

• nutritional status at 60 mo

  60 months

Study Arms (2)

Comparison group

NO INTERVENTION

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.

Early delivery of iodized salt

EXPERIMENTAL

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

Interventions

Iodized salt OTHER

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.

Early delivery of iodized salt

Eligibility Criteria

• Age: 5 Months - 61 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children within 15 days of 6, 18, and 60 months

You may not qualify if:

• severe cognitive impairment so child cannot respond to Bayley Scales of Infant and Toddler Development III test

Sponsors & Collaborators

• McGill University: lead
• Micronutrient Initiative: collaborator
• Ethiopian Health and Nutrition Research Institute: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H3A 2T5, Canada

Location

MeSH Terms

Conditions

Goiter; Congenital Hypothyroidism

Interventions

iodized salt

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypothyroidism

Study Officials

• Grace S Marquis, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Frances Aboud, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Aregash Samuel, MSc

  Ethiopian Health and Nutrition Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Canadian Research Chair in Social and Environmental Aspects of Nutrition

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: May 6, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

CA (1)