Pregnancy RelatedPhase 3MIFA-ACTNCT06069856
Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial
A Phase 3 study testing Iron Folic Acid Tablets with 60 mg of iron and Multiple Micronutrient Supplements with 60 mg of elemental iron in people with Pregnancy Related, run by George Washington University.
Trial summary
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. 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?
- Iron Folic Acid Tablets with 60 mg of 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
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2027to Dec 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 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Christopher R Sudfeld, ScD, ScM contact
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- Iron Folic Acid Tablets with 60 mg of iron, Multiple Micronutrient Supplements with 60 mg of elemental iron
- Keywords
- Acceptability, Multiple Micronutrient Supplementation, Iron, IFA, Tanzania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Folic Acid Tablets with 60 mg of ironDietary supplement
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
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.
| Study group | Role | What they receive |
|---|---|---|
| MMS with 60 mg of iron first, then IFA with 60 mg of iron | Experimental | 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 Receives: Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron |
| IFA with 60 mg of iron first, then MMS with 60 mg of iron | Experimental | 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 Receives: Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron; 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.
Acceptability of formulation
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).
Measured: At two months of taking each regimen
Secondary outcomes (3)
Most preferred formulation
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.
Measured: At four months (after taking both regimens)
Side Effects of formulation
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
Measured: At two months of taking each regimen
Adherence
Percentage pill count of the number of supplements taken
Measured: At two months of taking each regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jun 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, 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
- Responsible party
- Principal investigator, Emily Smith, George Washington University
- Investigators
- Blair Wylie, MD, MPH, Principal investigator, Columbia UniversityHonorati Masanja, PhD, Principal investigator, Ifakara Health InstituteAlfa Muhihi, PhD, Principal investigator, Africa Academy of Public HealthAndrea Pembe, MD, MMed, PhD, FCOG, Principal investigator, Muhimbili University of Health and Allied SciencesEmily R Smith, ScD, MPH, Principal investigator, The George Washington UniversityChristopher R Sudfeld, ScD, ScM, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069856
- Sponsor's protocol ID
- MIFA-ACT
- Acronym
- MIFA-ACT
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania
- ClinicalTrials.gov ID
- NCT06069856
- Acronym / sponsor ID
- MIFA-ACT / MIFA-ACT
- Conditions
- Pregnancy Related
- Keywords
- Acceptability, Multiple Micronutrient Supplementation, Iron, IFA, Tanzania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 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
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMS with 60 mg of iron first, then IFA with 60 mg of iron | Experimental | Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironWomen 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 |
| IFA with 60 mg of iron first, then MMS with 60 mg of iron | Experimental | Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron, Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental ironWomen 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 |
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 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Iron Folic Acid Tablets with 60 mg of ironIFA 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 | IFA with 60 mg of iron first, then MMS with 60 mg of iron, MMS with 60 mg of iron first, then IFA with 60 mg of 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. | Dietary supplement | IFA with 60 mg of iron first, then MMS with 60 mg of iron, MMS with 60 mg of iron first, then IFA with 60 mg of iron |
Primary outcome
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).
3 secondary outcomes
Most preferred formulation
Time frame: At four months (after taking both regimens)
Side Effects of formulation
Time frame: At two months of taking each regimen
Adherence
Time frame: At two months of taking each regimen
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 4 Jun 2026.
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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.
Christopher R Sudfeld, ScD, ScM contact
Blair Wylie, MD, MPH principal investigator
Columbia University
Honorati Masanja, PhD principal investigator
Ifakara Health Institute
Alfa Muhihi, PhD principal investigator
Africa Academy of Public Health
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron Folic Acid Tablets with 60 mg of iron and Multiple Micronutrient Supplements with 60 mg of elemental iron in people with Pregnancy Related, run by George Washington University.
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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Acceptability of formulation (time frame: At two months of taking each regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.