Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial (MIFA-ACT)

June 3, 2026 updated by: Emily Smith, George Washington University

Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania

This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Attending first ANC visit at the study clinic
  • Pregnant women ≤ 15 weeks of gestation
  • Aged ≥ 18 years
  • Intending to stay in the study area for the duration of study
  • Provides informed consent

Exclusion Criteria:

  • Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
  • Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
  • Concurrent participation in other nutritional supplementation trial
  • Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MMS with 60 mg of iron first, then IFA with 60 mg of iron
Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
Dietary supplement: Iron Folic Acid Tablets with 60 mg of iron
IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization
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.
Experimental: IFA with 60 mg of iron first, then MMS with 60 mg of iron
Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months
Dietary supplement: Iron Folic Acid Tablets with 60 mg of iron
IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of formulation
Time Frame: At two months of taking each regimen
To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).
At two months of taking each regimen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Most preferred formulation
Time Frame: At four months (after taking both regimens)
To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.
At four months (after taking both regimens)
Side Effects of formulation
Time Frame: At two months of taking each regimen
To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron
At two months of taking each regimen
Adherence
Time Frame: At two months of taking each regimen
Percentage pill count of the number of supplements taken
At two months of taking each regimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Collaborators

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

Investigators

  • Principal Investigator: Honorati Masanja, PhD, Ifakara Health Institute
  • Principal Investigator: Blair Wylie, MD, MPH, Columbia University
  • Principal Investigator: Alfa Muhihi, PhD, Africa Academy of Public Health
  • Principal Investigator: Andrea Pembe, MD, MMed, PhD, FCOG, Muhimbili University of Health and Allied Sciences
  • Principal Investigator: Emily R Smith, ScD, MPH, The George Washington University
  • Principal Investigator: Christopher R Sudfeld, ScD, ScM, Harvard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIFA-ACT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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