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Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia

ConditionsIodine DeficiencyNutrition PoorDevelopment, InfantBreastfeeding
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBrown University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • UNIMMAP Multiple Micronutrient Supplement

    Dietary supplement

    Iodine Containing Multiple Micronutrient Supplement once daily

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Iodine Containing Multiple Micronutrient (UNIMMAP)Experimental treatment 1 intervention
Group B: Routine postnatal careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

EEG Power

Absolute power of the alpha band

Time frame
6 months

Secondary outcomes

1

EEG Fc

EEG Functional Connectivity

Time frame
6 months
2

BMIC

Breast Milk Iodine Concentration at 3 month

Time frame
3 month post partum
3

Visual Evoked Potentials

P1 Latency

Time frame
6 months post partum
4

Infant HCAZ at 6 months

Infant head circumference Z-score

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Addis Continental Institute of Public Health

Collaborator

Brigham and Women's Hospital

Collaborator

Johns Hopkins Bloomberg School of Public Health

Collaborator

University of South Carolina

Collaborator

Boston Children's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: