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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Iodine Containing Multiple Micronutrient Supplement once daily
Visual Evoked Potentials
P1 Latency
Time frame: 6 months post partum
BMIC
Breast Milk Iodine Concentration at 1 month
Time frame: 1 month post partum
EEG Fc
EEG Functional Connectivity
Time frame: 6 months
Infant HCAZ at 6 months
Infant head circumference Z-score
Time frame: 6 months
Infant UIC
Infant Urine Iodine Concentration
Time frame: 6 months
Infant Tg
Dried blood spot thyroglobulin
Time frame: 6 months
Infant TSH
Thyroid Stimulating Hormone
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.