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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University
Harvard School of Public Health (HSPH)
Ifakara Health Institute
Muhimbili University of Health and Allied Sciences
Africa Academy for Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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