Iodine DeficiencyPhase 4EMECHATNCT05901766
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
A Phase 4 study testing UNIMMAP Multiple Micronutrient Supplement in people with Iodine Deficiency and Nutrition Poor, run by Brown University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Nutrition Poor, Development, Infant
- What is being tested?
- UNIMMAP Multiple Micronutrient Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kaitlin Mason, MPH, BSN contact
About this study
Official title: Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment
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:
Read more
- What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?
- What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
- 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.
- Conditions
- Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
- Being tested
- UNIMMAP Multiple Micronutrient Supplement
- Medical subject headings
- Malnutrition, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNIMMAP Multiple Micronutrient SupplementDietary supplement
Iodine Containing Multiple Micronutrient Supplement once daily
| Study group | Role | What they receive |
|---|---|---|
| Iodine Containing Multiple Micronutrient (UNIMMAP) | Experimental | UNIMMAP 1 tablet po once daily from birth to 6 months postpartum Receives: Dietary Supplement: UNIMMAP Multiple Micronutrient Supplement |
| Routine postnatal care | No intervention | Routine postnatal care per Ethiopian Ministry of Health guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Power
Absolute power of the alpha band
Measured: 6 months
Secondary outcomes (13)
EEG Fc
EEG Functional Connectivity
Measured: 6 months
BMIC
Breast Milk Iodine Concentration at 3 month
Measured: 3 month post partum
Visual Evoked Potentials
P1 Latency
Measured: 6 months post partum
Infant HCAZ at 6 months
Infant head circumference Z-score
Measured: 6 months
Infant UIC
Infant Urine Iodine Concentration
Measured: 6 months
Infant Tg
Dried blood spot thyroglobulin
Measured: 3 months
Infant TSH
Thyroid Stimulating Hormone
Measured: 3 months
Neuromotor response
Generalized movement assessment (GMA)
Measured: 3 months
Neuromotor response
Hammersmith Infant Neurological Examination (HINE)
Measured: 6 months
Global development
Global Scales for Early Development (GSED)
Measured: 6 months
Eye Tracking
Cecile and MAAP visual attention tasks
Measured: 6 months
Breast milk B vitamin concentration
Breastmilk B-complex vitamin concentration
Measured: 6 months
Maternal anemia
Maternal hemoglobin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Nov 2026 (estimated)
- Primary completion4 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Anne Shee CC Lee, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901766
- Sponsor's protocol ID
- 2021P002634
- Acronym
- EMECHAT
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment
- ClinicalTrials.gov ID
- NCT05901766
- Acronym / sponsor ID
- EMECHAT / 2021P002634
- Conditions
- Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- 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
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?
- What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individually randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Iodine Containing Multiple Micronutrient (UNIMMAP) | Experimental | Dietary Supplement: UNIMMAP Multiple Micronutrient SupplementUNIMMAP 1 tablet po once daily from birth to 6 months postpartum |
| Routine postnatal care | No intervention | –Routine postnatal care per Ethiopian Ministry of Health guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNIMMAP Multiple Micronutrient SupplementIodine Containing Multiple Micronutrient Supplement once daily | Dietary supplement | Iodine Containing Multiple Micronutrient (UNIMMAP) |
Primary outcome
EEG Power
Time frame: 6 months
Absolute power of the alpha band
13 secondary outcomes
EEG Fc
Time frame: 6 months
BMIC
Time frame: 3 month post partum
Visual Evoked Potentials
Time frame: 6 months post partum
Infant HCAZ at 6 months
Time frame: 6 months
Infant UIC
Time frame: 6 months
Infant Tg
Time frame: 3 months
Infant TSH
Time frame: 3 months
Neuromotor response
Time frame: 3 months
Neuromotor response
Time frame: 6 months
Global development
Time frame: 6 months
Eye Tracking
Time frame: 6 months
Breast milk B vitamin concentration
Time frame: 6 months
Maternal anemia
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaitlin Mason, MPH, BSN contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing UNIMMAP Multiple Micronutrient Supplement in people with Iodine Deficiency and Nutrition Poor, run by Brown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Lee, MD, MPH (401-430-8015, anne_cc_lee@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Power (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.