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

Brown University

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Dietary Supplement: UNIMAP Multiple Micronutrient Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05901766

2021P002634

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 years to 2 weeks old

Volunteers: Accepts Healthy Volunteers

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
• Infant with 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Iodine Containing Multiple Micronutrient (UNIMAP)

Experimental group

Description:

UNIMAP 1 tablet po once daily from birth to 6 months postpartum

Treatment:

Dietary Supplement: UNIMAP Multiple Micronutrient Supplement

Routine postnatal care

No Intervention group

Description:

Routine postnatal care per Ethiopian Ministry of Health guidelines