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| Name | Class |
|---|---|
| Addis Continental Institute of Public Health | OTHER |
| Brigham and Women's Hospital | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
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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:
Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodine Containing Multiple Micronutrient (UNIMMAP) | Experimental | UNIMMAP 1 tablet po once daily from birth to 6 months postpartum |
|
| Routine postnatal care | No Intervention | Routine postnatal care per Ethiopian Ministry of Health guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNIMMAP Multiple Micronutrient Supplement | Dietary Supplement | Iodine Containing Multiple Micronutrient Supplement once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| EEG Power | Absolute power of the alpha band | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Fc | EEG Functional Connectivity | 6 months |
| BMIC | Breast Milk Iodine Concentration at 3 month | 3 month post partum |
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To be eligible, women will be required to meet the following inclusion criteria:
Exclusion criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Lee, MD, MPH | Contact | 401-430-8015 | anne_cc_lee@brown.edu | |
| Kaitlin Mason, MPH, BSN | Contact | kaitlin_mason@brown.edu |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| University of South Carolina |
| OTHER |
| Boston Children's Hospital | OTHER |
Individually randomized controlled trial
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| Visual Evoked Potentials | P1 Latency | 6 months post partum |
| 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 | 3 months |
| Infant TSH | Thyroid Stimulating Hormone | 3 months |
| Neuromotor response | Generalized movement assessment (GMA) | 3 months |
| Neuromotor response | Hammersmith Infant Neurological Examination (HINE) | 6 months |
| Global development | Global Scales for Early Development (GSED) | 6 months |
| Eye Tracking | Cecile and MAAP visual attention tasks | 6 months |
| Breast milk B vitamin concentration | Breastmilk B-complex vitamin concentration | 6 months |
| Maternal anemia | Maternal hemoglobin | 6 months |