Breastfeeding, Development, Infant, Iodine Deficiency, Nutrition Poor
Conditions
Brief summary
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: 1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? 2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? 3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation? 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.
Interventions
DIETARY_SUPPLEMENTUNIMMAP Multiple Micronutrient Supplement
Iodine Containing Multiple Micronutrient Supplement once daily
Sponsors
Brown University
Addis Continental Institute of Public Health
Brigham and Women's Hospital
Johns Hopkins Bloomberg School of Public Health
University of South Carolina
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Individually randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible, women will be required to meet the following inclusion criteria: * Maternal age 18 years or above, singleton pregnancy, * data available on Last Menstrual Period (LMP) or early ultrasound, * Intention to exclusively feed breastmilk for 4 to 6 months, * Intention to stay in the study catchment area for at least 6 months, * Willingness to take a daily supplement of MMS for 6 months
Exclusion criteria
include: * Severe maternal morbidity (postpartum eclampsia, postpartum hemorrhage), * Maternal condition leading to inability for infant to directly/exclusively breastfeed (maternal mastectomy, or other breast surgery), * Breast cancer, * Tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG Power | 6 months | Absolute power of the alpha band |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG Fc | 6 months | EEG Functional Connectivity |
| BMIC | 3 month post partum | Breast Milk Iodine Concentration at 3 month |
| Visual Evoked Potentials | 6 months post partum | P1 Latency |
| Infant HCAZ at 6 months | 6 months | Infant head circumference Z-score |
| Infant UIC | 6 months | Infant Urine Iodine Concentration |
| Infant Tg | 3 months | Dried blood spot thyroglobulin |
| Infant TSH | 3 months | Thyroid Stimulating Hormone |
| Neuromotor response | 3 months | Generalized movement assessment (GMA) |
| Global development | 6 months | Global Scales for Early Development (GSED) |
| Eye Tracking | 6 months | Cecile and MAAP visual attention tasks |
| Breast milk B vitamin concentration | 6 months | Breastmilk B-complex vitamin concentration |
| Maternal anemia | 6 months | Maternal hemoglobin |
Contacts
CONTACTAnne Lee, MD, MPH
CONTACTKaitlin Mason, MPH, BSN
Outcome results
None listed