Pregnancy RelatedPhase 3MMS-MAPNCT06079918

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

A Phase 3 study testing Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron and Multiple Micronutrient Supplements with 60 mg of elemental iron in people with Pregnancy Related, run by George Washington University at 1 site in Tanzania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. 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: Pregnancy Related
What is being tested?: Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron and Multiple Micronutrient Supplements with 60 mg of elemental iron
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,381 participants
Where: 1 siteTanzania
Study dates: 3 Mar 2025to Jun 2027
Phase: Phase 3
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

Attending first ANC visit at study clinics
Pregnant women < 20 weeks gestation by last menstrual period (LMP)
Aged ≥ 18 years old
Intending to stay in Dar es Salaam until 6 weeks post delivery
Provides informed consent

Who cannot join

Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
Concurrently enrolled in another nutritional clinical trial
Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily R Smith, ScD, MPH contact

202-994-3589

emilysmith@gwu.edu

Christopher R Sudfeld, ScD, ScM contact

csudfeld@hsph.harvard.edu

Tanzania1 site, 1 recruiting

Muhimbili University of Health and Allied Sciences
Dar es Salaam
Andrea Pembe, MD, 255-754-262-483, bpembe@muhas.ac.tz
Recruiting

Other trials in Tanzania

About this study

Official title: Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia

Conditions: Pregnancy Related
Being tested: Multiple Micronutrient Supplements with 30 mg of elemental iron, Multiple Micronutrient Supplements with 45 mg of elemental iron, Multiple Micronutrient Supplements with 60 mg of elemental iron
Keywords: Pregnancy, Multiple Micronutrient Supplementation, Iron, Anemia, Tanzania
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multiple Micronutrient Supplements with 30 mg of elemental ironDietary supplement
MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.
Multiple Micronutrient Supplements with 45 mg of elemental ironDietary supplement
MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
Multiple Micronutrient Supplements with 60 mg of elemental ironDietary supplement
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.

Study groups in NCT06079918
Study group	Role	What they receive
MMS with 30 mg iron	Active comparator	MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron Receives: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron
MMS with 45 mg iron	Experimental	MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients Receives: Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron
MMS with 60 mg iron	Experimental	MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients Receives: Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of pregnant women with third-trimester moderate or severe anemia
Defined as a hemoglobin concentration <10 g/dL.
Measured: 3rd trimester (weeks 28-42 of pregnancy)

Secondary outcomes (31)

Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Measured: 6 weeks postpartum
Proportion of pregnant women with anemia
Hb concentration < 11 g/dL
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of postpartum women with anemia
Hb concentration < 12 g/dL
Measured: 6 weeks postpartum
Maternal serum ferritin
Inflammation-adjusted serum ferritin
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of pregnant women with iron deficiency
Inflammation-adjusted serum ferritin < 15 ug/L
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of pregnant women with iron deficiency anemia
Anemia (Hb < 11 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L)
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with preeclampsia
Gestational hypertension and gestational proteinuria among participants without chronic hypertension or gestational proteinuria among participants with chronic hypertension (superimposed preeclampsia) or clinical diagnosis of preeclampsia by managing clinical team or development of severe features of preeclampsia even in the absence of proteinuria
Measured: From 20 weeks gestation through delivery
Proportion of women with antepartum bleeding
Self-reported or clinical diagnosis of bleeding from or into the genital tract
Measured: From 24 weeks gestation through delivery
Proportion of women with postpartum hemorrhage
Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage
Measured: From delivery through 42 days post delivery
Proportion of women with infection-related severe maternal outcomes
Severe infection-related such as hospitalization for infection, women presenting with WHO near-miss criteria to define organ system dysfunction, invasive procedure to treat the source of infection (vacuum aspiration, dilatation and curettage, wound debridement, drainage, laparotomy and lavage, other surgery), or maternal death from infection.
Measured: During pregnancy through 42 days postpartum
Proportion of women with pregnancy-related death
Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death
Measured: Pregnancy through 42 days of pregnancy termination
Proportion of women with symptoms consistent with depression
Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with symptoms consistent with depression
Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety
Measured: 6 weeks postpartum
Proportion of women with symptoms consistent with fatigue
FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue.
Measured: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with symptoms consistent with fatigue
FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue.
Measured: 6 weeks postpartum
Proportion of women with malaria infection
Based on HRP2 biomarker or rapid-diagnostic tests (RDTs)
Measured: Pregnancy through 42 days postpartum
Proportion of fetal deaths
A product of human conception, irrespective of the duration of the pregnancy, which, after expulsion or extraction, does not breath or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached
Measured: At pregnancy termination (weeks 1-42 of pregnancy)
Proportion of stillbirths
Fetal death ≥ 28 weeks gestation
Measured: At pregnancy termination (weeks 1-42 of pregnancy)
Birthweight
Continuous birthweight among live births
Measured: At birth
Proportion of live births with low birthweight
Live birth with birthweight < 2500 g
Measured: At birth
Gestational age at birth
Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births
Measured: At birth
Proportion of preterm live births
Live birth <37 weeks gestation (based on best obstetric estimate)
Measured: At birth
Birthweight for gestational age
Continuous centile based on INTERGROWTH-21st standard birth centile among live births
Measured: At birth
Proportion of small-for-gestational age live births (<10th percentile)
Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births
Measured: At birth
Proportion of small-for-gestational age live births (<3rd percentile)
Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births
Measured: At birth
Infant hemoglobin concentration
Continuous Hb concentration measured from capillary blood by complete blood count
Measured: At 6 weeks of age
Infant serum ferritin
Continuous inflammation adjusted serum ferritin
Measured: At 6 weeks of age
Proportion of infants with iron deficiency
Inflammation-adjusted serum ferritin < 20 ug/L
Measured: At 6 weeks of age
Proportion of neonatal deaths
Death of liveborn infant during the first 28 completed days of life
Measured: From birth to 28 days of age
Proportion of infant deaths < 42 days
Death of a live born infant during the first 42 completed days of life
Measured: From birth to 42 days of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 2025Jun 2027

First posted12 Oct 2023
Study start3 Mar 2025
Primary completionMar 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
More trials run by George Washington 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6,381 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06079918
Sponsor's protocol ID: MMS-MAP
Acronym: MMS-MAP
Status last verified: Jul 2026
First submitted: 25 Jul 2023
Last updated: 14 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Smith ER, Muhihi A, Wylie BJ, Mugusi S, Aboud S, Bakari M, Fawzi W, Kinyogoli S, Oakley EM, Pan Q, Sando MM, Brownlee VS, Pembe AB, Sudfeld CR, Masanja H. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Trials. 2025 Jun 14;26(1):206. doi: 10.1186/s13063-025-08906-7.
PubMed 40517226

Interested in taking part?

Emily R Smith, ScD, MPH

202-994-3589

emilysmith@gwu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
ClinicalTrials.gov ID: NCT06079918
Acronym / sponsor ID: MMS-MAP / MMS-MAP
Conditions: Pregnancy Related
Keywords: Pregnancy, Multiple Micronutrient Supplementation, Iron, Anemia, Tanzania
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 6,381 participants (estimated)
Lead sponsor: George Washington UniversityUniversity, hospital or other
Collaborators: Ifakara Health Institute, Harvard School of Public Health (HSPH), Muhimbili University of Health and Allied Sciences, Africa Academy for Public Health, Columbia University
Study start: 3 Mar 2025 (actual)
Primary completion: Mar 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 12 Oct 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MMS with 30 mg iron	Active comparator	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental ironMMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
MMS with 45 mg iron	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental ironMMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
MMS with 60 mg iron	Experimental	Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironMMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Attending first ANC visit at study clinics
Pregnant women < 20 weeks gestation by last menstrual period (LMP)
Aged ≥ 18 years old
Intending to stay in Dar es Salaam until 6 weeks post delivery
Provides informed consent

Key exclusion criteria (4 listed)

Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
Concurrently enrolled in another nutritional clinical trial
Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

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
Multiple Micronutrient Supplements with 30 mg of elemental ironMMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.	Dietary supplement	MMS with 30 mg iron
Multiple Micronutrient Supplements with 45 mg of elemental ironMMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.	Dietary supplement	MMS with 45 mg iron
Multiple Micronutrient Supplements with 60 mg of elemental ironMMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.	Dietary supplement	MMS with 60 mg iron

Primary outcome

Proportion of pregnant women with third-trimester moderate or severe anemia
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Defined as a hemoglobin concentration <10 g/dL.

31 secondary outcomes

Maternal hemoglobin concentration
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Maternal hemoglobin concentration
Time frame: 6 weeks postpartum
Proportion of pregnant women with anemia
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of postpartum women with anemia
Time frame: 6 weeks postpartum
Maternal serum ferritin
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of pregnant women with iron deficiency
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of pregnant women with iron deficiency anemia
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with preeclampsia
Time frame: From 20 weeks gestation through delivery
Proportion of women with antepartum bleeding
Time frame: From 24 weeks gestation through delivery
Proportion of women with postpartum hemorrhage
Time frame: From delivery through 42 days post delivery
Proportion of women with infection-related severe maternal outcomes
Time frame: During pregnancy through 42 days postpartum
Proportion of women with pregnancy-related death
Time frame: Pregnancy through 42 days of pregnancy termination
Proportion of women with symptoms consistent with depression
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with symptoms consistent with depression
Time frame: 6 weeks postpartum
Proportion of women with symptoms consistent with fatigue
Time frame: 3rd trimester (weeks 28-42 of pregnancy)
Proportion of women with symptoms consistent with fatigue
Time frame: 6 weeks postpartum
Proportion of women with malaria infection
Time frame: Pregnancy through 42 days postpartum
Proportion of fetal deaths
Time frame: At pregnancy termination (weeks 1-42 of pregnancy)
Proportion of stillbirths
Time frame: At pregnancy termination (weeks 1-42 of pregnancy)
Birthweight
Time frame: At birth
Proportion of live births with low birthweight
Time frame: At birth
Gestational age at birth
Time frame: At birth
Proportion of preterm live births
Time frame: At birth
Birthweight for gestational age
Time frame: At birth
Proportion of small-for-gestational age live births (<10th percentile)
Time frame: At birth
Proportion of small-for-gestational age live births (<3rd percentile)
Time frame: At birth
Infant hemoglobin concentration
Time frame: At 6 weeks of age
Infant serum ferritin
Time frame: At 6 weeks of age
Proportion of infants with iron deficiency
Time frame: At 6 weeks of age
Proportion of neonatal deaths
Time frame: From birth to 28 days of age
Proportion of infant deaths < 42 days
Time frame: From birth to 42 days of age

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 14 Jul 2026.
Derived from this study: PubMed 40517226Smith ER, Muhihi A, Wylie BJ, Mugusi S, Aboud S, Bakari M, Fawzi W, Kinyogoli S, Oakley EM, Pan Q, Sando MM, Brownlee VS, Pembe AB, Sudfeld CR, Masanja H. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Trials. 2025 Jun 14;26(1):206. doi: 10.1186/s13063-025-08906-7.

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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.

Emily R Smith, ScD, MPH contact

202-994-3589

emilysmith@gwu.edu

Christopher R Sudfeld, ScD, ScM contact

csudfeld@hsph.harvard.edu

Blair Wylie, MD, MPH principal investigator

Columbia University

Honorati Masanja, PhD principal investigator

Ifakara Health Institute

Alfa Muhihi, MD, MPH principal investigator

Africa Academy for Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Emily R Smith, ScD, MPH (202-994-3589, emilysmith@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of pregnant women with third-trimester moderate or severe anemia (time frame: 3rd trimester (weeks 28-42 of pregnancy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079918, which also lists 1 linked publication.

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 14 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.