Trial record 8 of 8 for:    "Congenital hypothyroidism"

The Effects of Iodized Salt on Cognitive Development in Ethiopia

This study has been completed.
Sponsor:
Collaborators:
MicroNutrient Initiative
Ethiopian Health and Nutrition Research Institute (EHNRI)
Information provided by (Responsible Party):
Grace S. Marquis, McGill University
ClinicalTrials.gov Identifier:
NCT01349634
First received: April 20, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Iodine Deficiency
Goiter
Cretinism
Other: Iodized salt

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 4800
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Months to 61 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349634

Locations
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H3A 2T5
Sponsors and Collaborators
McGill University
MicroNutrient Initiative
Ethiopian Health and Nutrition Research Institute (EHNRI)
Investigators
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
  More Information

No publications provided

Responsible Party: Grace S. Marquis, Associate Professor, Canadian Research Chair in Social and Environmental Aspects of Nutrition, McGill University
ClinicalTrials.gov Identifier: NCT01349634     History of Changes
Other Study ID Numbers: 10-1152-MCGUNI-01
Study First Received: April 20, 2011
Last Updated: May 9, 2014
Health Authority: Ethiopia: Ethical Review Committee
Ethiopia: Ethiopia Science and Technology Commission
Canada: Ethics Review Committee

Keywords provided by McGill University:
iodine
goiter
cretinism
child nutrition
cognition

ClinicalTrials.gov processed this record on September 18, 2014