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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.
In iodine-deficient countries or regions that have inadequate iodized salt distribution, WHO recommends choosing one of two methods to improve iodine intakes in breastfeeding infants:
Method 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother Method 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.
The mountains of southern Morocco are areas of iodine deficiency. Although the government has been promoting iodization of salt, there are hundreds of small salt producers in the mountains who do not have the funding or infrastructure to iodize their salt, and thus many rural populations still are consuming non-iodized locally-produced salt. At the study site, a 2009 pilot survey of urinary iodine has found that the population in this region is moderately iodine sufficient.
Thus, according to WHO, breastfeeding women and/or their infants should be provided with oral iodine supplementation. But which of the above supplementation methods is preferable? Controlled studies clearly demonstrate that iodine repletion in moderate-to severely iodine deficient school-age children increases insulin-like growth factor (IGF)-1 and insulin-like growth factor binding protein (IGFBP)-3 concentrations and improves somatic growth (height and weight). But whether supplying adequate iodine to iodine deficient infants improves their somatic growth has not been tested.
Therefore, the study hypotheses are: In Moroccan infants who are breastfeeding, method 2 will be more efficacious than method 1 in:
The study design will be a double-blind, randomized controlled intervention trial in southern Morocco lasting 1 year. Healthy mother-infant pairs (n=240) who are breastfeeding will be recruited while the infant is >1 mo of age. They will be divided into two groups as follows:
1) method 1: mother receives 400 mg of iodine as oral iodized oil + infant receives placebo capsule; or 2) method 2: mother receives placebo capsule + infant receives 100 mg oral iodized oil.
The outcomes will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodized oil to mother | Experimental | 400 mg iodine as iodized oil to breastfeeding mother |
|
| Iodized oil to infant | Active Comparator | 100 mg of iodine as iodized oil to infant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodized oil | Dietary Supplement | 400 mg of iodine vs 100 mg of iodine as iodized oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant height and weight | 1st year after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Infant head circumference | 1st year after birth | |
| Thyroid hormone concentrations | 1st year after birth | |
| Urinary iodine concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Zimmermann, MD | Swiss Federal Institute of Technology Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semilila Faculty of Sciences | Marrakesh | Marrakech | Morocco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24622750 | Derived | Bouhouch RR, Bouhouch S, Cherkaoui M, Aboussad A, Stinca S, Haldimann M, Andersson M, Zimmermann MB. Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 Mar;2(3):197-209. doi: 10.1016/S2213-8587(13)70155-4. Epub 2013 Nov 22. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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| 1st year after birth |
| Infant development score | 1st year after birth |
| Biological Products |
| D045424 | Complex Mixtures |