Iodine Deficiency Clinical Trial
— INSIGHTOfficial title:
Iodized Oil Supplementation During Infancy
In iodine-deficient countries or regions that have inadequate iodized salt distribution, the World Health Organization (WHO) recommends choosing one of two methods to improve iodine intakes in breastfeeding infants: 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother, or 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the infant. However, the relative efficacy of these two methods of providing iodine to the newborn has never been directly compared. Whether the first method of iodine supplementation to the breast feeding mother can significantly improve iodine supply and maintain normal thyroid function in her infant remains unclear. This study will directly compare these two strategies. The hypothesis is that the two strategies will be equally effective in providing iodine to the newborn.
Status | Completed |
Enrollment | 241 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 40 Years |
Eligibility |
Inclusion Criteria: - breastfeeding term infant Exclusion Criteria: - not breastfeeding - major medical illnesses |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Morocco | Semilila Faculty of Sciences | Marrakech |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology |
Morocco,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infant height and weight | 1st year after birth | No | |
Secondary | Infant head circumference | 1st year after birth | No | |
Secondary | Thyroid hormone concentrations | 1st year after birth | Yes | |
Secondary | Urinary iodine concentrations | 1st year after birth | No | |
Secondary | Infant development score | 1st year after birth | No |
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