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Recruiting NCT06079918

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

Phase III Interventional Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Dietary supplement Multiple Micronutrient Supplements with 30 mg of elemental iron
    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.
  • Dietary supplement Multiple Micronutrient Supplements with 45 mg of elemental iron
    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.
  • Dietary supplement Multiple Micronutrient Supplements with 60 mg of elemental iron
    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 outcome measures

  • Proportion of pregnant women with third-trimester moderate or severe anemia [Time frame: 3rd trimester (weeks 28-42 of pregnancy)]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Tanzania · 1 center
  • Muhimbili University of Health and Allied Sciences — Dar es Salaam

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. 20 PMID 40517226

Identifiers

NCT: NCT06079918 · MMS-MAP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗