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

Study acronym: EMECHAT
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Start date: May 1, 2026 to Nov 1, 2026
    • Study title expanded, about 3 words
    v9
  2. Primary completion pushed from Dec 30, 2026 to Oct 4, 2027v8 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Study completion pushed from Apr 1, 2027 to Mar 31, 2028
    • Interventions: UNIMAP Multiple Micronutrient Supplement (Dietary Supplement) to UNIMMAP Multiple Micronutrient Supplement (Dietary Supplement)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 5 to 13
    • Collaborators: 4 to 5
  3. Start date: Jan 1, 2026 to May 1, 2026v7
  4. Primary completion date: Jan 1, 2026 to Dec 30, 2026
    • Start date: May 1, 2025 to Jan 1, 2026
    • Study completion date: Jan 1, 2026 to Apr 1, 2027
    v6
  5. Primary and study completion dates: Jan 2026 to Jan 1, 2026
    • Start date: May 2025 to May 1, 2025
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Lead sponsor: Brigham and Women's Hospital to Brown University
    • Start date: Nov 2024 to May 2025
    • Collaborators: 1 to 4
    • Eligibility criteria expanded, about 2 words
    v4
  2. Start date: May 2024 to Nov 2024
    • Primary and study completion dates: Nov 2025 to Jan 2026
    • Collaborators expanded, about 7 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05901766
Lead Sponsor Brown University
Collaborators: 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
Conditions
(from sponsor)		 Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
Related terms Breast Feeding, Malnutrition
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov