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Not yet recruitingNCT05901766EMECHATUpdated Sep 9, 2026

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

A Phase 4 interventional study of UNIMMAP Multiple Micronutrient Supplement in Iodine Deficiency, Nutrition Poor and Development, Infant, sponsored by Brown University. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Brown University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Iodine Deficiency
  • Nutrition Poor
  • Development, Infant
  • Breastfeeding
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 600 is above the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.

Browse Brown University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

To be eligible, women will be required to meet the following inclusion criteria:

  • 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,
  • Willingness to take a daily supplement of MMS for 6 months

Exclusion criteria include:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Iodine Containing Multiple Micronutrient (UNIMMAP)

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

    Dietary Supplement: UNIMMAP Multiple Micronutrient Supplement

  • No intervention
    Routine postnatal care

    Routine postnatal care per Ethiopian Ministry of Health guidelines

Interventions

  • Dietary supplementUNIMMAP Multiple Micronutrient Supplement

    Iodine Containing Multiple Micronutrient Supplement once daily

06

What researchers measure

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

  5. Infant UIC

    Infant Urine Iodine Concentration

    Time frame: 6 months

  6. Infant Tg

    Dried blood spot thyroglobulin

    Time frame: 3 months

  7. Infant TSH

    Thyroid Stimulating Hormone

    Time frame: 3 months

  8. Neuromotor response

    Generalized movement assessment (GMA)

    Time frame: 3 months

  9. Neuromotor response

    Hammersmith Infant Neurological Examination (HINE)

    Time frame: 6 months

  10. Global development

    Global Scales for Early Development (GSED)

    Time frame: 6 months

  11. Eye Tracking

    Cecile and MAAP visual attention tasks

    Time frame: 6 months

  12. Breast milk B vitamin concentration

    Breastmilk B-complex vitamin concentration

    Time frame: 6 months

  13. Maternal anemia

    Maternal hemoglobin

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.

Of 17 phase 4 interventional studies under Malnutrition, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2023
First posted
Jun 13, 2023
StartEst.
Nov 1, 2026
Primary completionEst.
Oct 4, 2027
CompletionEst.
Mar 31, 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
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
Responsible party
Anne Shee CC Lee (Levinger Family Professor of Pediatrics, Brown University) — Principal investigator
First posted
Jun 13, 2023
Start date
Nov 1, 2026 (estimated)
Primary completion
Oct 4, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Anne Lee, MD, MPH
Contact
anne_cc_lee@brown.edu
401-430-8015
Kaitlin Mason, MPH, BSN
Contact
kaitlin_mason@brown.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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