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NCT Number: NCT06079918

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

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. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

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Key information

Conditions

Pregnancy Related Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location status: Recruiting

Location contact

Andrea Pembe, MD

CONTACT

[email protected]

255-754-262-483

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Multiple Micronutrient Supplements with 30 mg of elemental iron

Dietary 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 iron

Dietary 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 iron

Dietary 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maternal hemoglobin concentration

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Continuous hemoglobin concentration measured from venous blood by complete blood count

  2. Maternal hemoglobin concentration

    Time frame: 6 weeks postpartum

    Continuous hemoglobin concentration measured from venous blood by complete blood count

  3. Proportion of pregnant women with anemia

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Hb concentration < 11 g/dL

  4. Proportion of postpartum women with anemia

    Time frame: 6 weeks postpartum

    Hb concentration < 12 g/dL

  5. Maternal serum ferritin

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Inflammation-adjusted serum ferritin

  6. Proportion of pregnant women with iron deficiency

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Inflammation-adjusted serum ferritin < 15 ug/L

  7. Proportion of pregnant women with iron deficiency anemia

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Anemia (Hb < 11 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L)

  8. Proportion of women with preeclampsia

    Time frame: From 20 weeks gestation through delivery

    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

  9. Proportion of women with antepartum bleeding

    Time frame: From 24 weeks gestation through delivery

    Self-reported or clinical diagnosis of bleeding from or into the genital tract

  10. Proportion of women with postpartum hemorrhage

    Time frame: From delivery through 42 days post delivery

    Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage

  11. Proportion of women with infection-related severe maternal outcomes

    Time frame: During pregnancy through 42 days postpartum

    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.

  12. Proportion of women with pregnancy-related death

    Time frame: Pregnancy through 42 days of pregnancy termination

    Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death

  13. Proportion of women with symptoms consistent with depression

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety

  14. Proportion of women with symptoms consistent with depression

    Time frame: 6 weeks postpartum

    Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher scores consistent with depression and anxiety

  15. Proportion of women with symptoms consistent with fatigue

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue.

  16. Proportion of women with symptoms consistent with fatigue

    Time frame: 6 weeks postpartum

    FACIT assessment score ranging from 0 to 52, with lower scores consistent with fatigue.

  17. Proportion of women with malaria infection

    Time frame: Pregnancy through 42 days postpartum

    Based on HRP2 biomarker or rapid-diagnostic tests (RDTs)

  18. Proportion of fetal deaths

    Time frame: At pregnancy termination (weeks 1-42 of pregnancy)

    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

  19. Proportion of stillbirths

    Time frame: At pregnancy termination (weeks 1-42 of pregnancy)

    Fetal death ≥ 28 weeks gestation

  20. Birthweight

    Time frame: At birth

    Continuous birthweight among live births

  21. Proportion of live births with low birthweight

    Time frame: At birth

    Live birth with birthweight < 2500 g

  22. Gestational age at birth

    Time frame: At birth

    Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births

  23. Proportion of preterm live births

    Time frame: At birth

    Live birth <37 weeks gestation (based on best obstetric estimate)

  24. Birthweight for gestational age

    Time frame: At birth

    Continuous centile based on INTERGROWTH-21st standard birth centile among live births

  25. Proportion of small-for-gestational age live births (<10th percentile)

    Time frame: At birth

    Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births

  26. Proportion of small-for-gestational age live births (<3rd percentile)

    Time frame: At birth

    Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births

  27. Infant hemoglobin concentration

    Time frame: At 6 weeks of age

    Continuous Hb concentration measured from capillary blood by complete blood count

  28. Infant serum ferritin

    Time frame: At 6 weeks of age

    Continuous inflammation adjusted serum ferritin

  29. Proportion of infants with iron deficiency

    Time frame: At 6 weeks of age

    Inflammation-adjusted serum ferritin < 20 ug/L

  30. Proportion of neonatal deaths

    Time frame: From birth to 28 days of age

    Death of liveborn infant during the first 28 completed days of life

  31. Proportion of infant deaths < 42 days

    Time frame: From birth to 42 days of age

    Death of a live born infant during the first 42 completed days of life

Other outcomes

  1. Percent adherence

    Time frame: During pregnancy (up to week 42)

    The percentage of days a pregnant woman takes a MMS pill out of the total number of days from randomization to delivery

  2. Diarrhea

    Time frame: During pregnancy (up to week 42)

    Self-reported any diarrhea symptoms during the intervention period

  3. Heartburn

    Time frame: During pregnancy (up to week 42)

    Self-reported any heartburn symptoms during the intervention period

  4. Constipation

    Time frame: During pregnancy (up to week 42)

    Self-reported any constipation symptoms during the intervention period

  5. Vomiting

    Time frame: During pregnancy (up to week 42)

    Self-reported any vomiting symptoms during the intervention period

  6. Nausea

    Time frame: During pregnancy (up to week 42)

    Self-reported any nausea symptoms during the intervention period

  7. Leg Cramps

    Time frame: During pregnancy (up to week 42)

    Self-reported any leg cramps during the intervention period

  8. Low back/pelvic pain

    Time frame: During pregnancy (up to week 42)

    Self-reported any low back/pelvic pain during the intervention period

  9. Maternal blood lead concentration

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Continuous blood lead concentration measured from whole blood

  10. Maternal plasma zinc concentration

    Time frame: 3rd trimester (weeks 28-42 of pregnancy)

    Continuous zinc concentration measured from plasma

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher R Sudfeld, ScD, ScM

CONTACT

[email protected]

Emily R Smith, ScD, MPH

CONTACT

[email protected]

202-994-3589

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Africa Academy for Public Health
  • Columbia University
  • Harvard School of Public Health (HSPH)
  • Ifakara Health Institute
  • Muhimbili University of Health and Allied Sciences

Registry information

Official study 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

Acronym: MMS-MAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 12, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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