Clinical trial NCT05901766: Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
Official title: Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Iodine Deficiency
Nutrition Poor
Development, Infant
Breastfeeding
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: Brigham and Women's Hospital
name: Johns Hopkins Bloomberg School of Public Health
name: University of South Carolina
First posted: 2023-06-13
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomized controlled trial
Primary purpose: TREATMENT

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 drop of 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 (IFA) and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Evoked Potentials
timeFrame: 6 months post partum
measure: BMIC
timeFrame: 1 month post partum
Secondary outcomes:
measure: EEG Fc
timeFrame: 6 months
measure: Infant HCAZ at 6 months
timeFrame: 6 months
measure: Infant UIC
timeFrame: 6 months
measure: Infant Tg
timeFrame: 6 months
measure: Infant TSH
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: