Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency. The main questions it aims to answer are: What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? How do iodine and iron interact with each other to affect thyroid function in the mother during pregnancy and lactation? Participants will be randomized to receive a daily iodine-containing multiple micronutrient tablet for 6 months after birth, or routine care. Mothers will provide a breast milk sample and drop of blood at 1 and 6 months. Infants will provide a urine sample and drop of blood at 1 and 6 months of age, and a developmental assessment including an Electroencephalogram at 6 months of age. Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.

Official Title
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Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment

Conditions
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Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding

Intervention / Treatment
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* Dietary Supplement: UNIMAP Multiple Micronutrient Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intention to breast feed at least 3 months Birth weight >2000g Exclusion Criteria: Intention to primarily feed by alternative sources (formula, animal milk) Multiple pregnancy Major congenital anomalies Infants with severe morbidity or developmental disorder Mother with HIV or chronic renal disease Plan to move out of study catchment area Does not agree to follow up or EEG/VEP

Ages Eligible for Study
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Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individually randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodine Containing Multiple Micronutrient (UNIMAP)<br>UNIMAP 1 tablet po once daily from birth to 6 months postpartum | Dietary Supplement: UNIMAP Multiple Micronutrient Supplement<br>* Iodine Containing Multiple Micronutrient Supplement once daily<br>|
| No Intervention: Routine care<br>Routine clinical care includes recommendation for iron folic acid for women with anemia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Evoked Potentials | P1 Latency | 6 months post partum | 
| BMIC | Breast Milk Iodine Concentration at 1 month | 1 month post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG Fc | EEG Functional Connectivity | 6 months | 
| Infant HCAZ at 6 months | Infant head circumference Z-score | 6 months | 
| Infant UIC | Infant Urine Iodine Concentration | 6 months | 
| Infant Tg | Dried blood spot thyroglobulin | 6 months | 
| Infant TSH | Thyroid Stimulating Hormone | 6 months |