Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

NCT ID: NCT06069856

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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This is an 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.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.

Study Groups

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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

Group Type EXPERIMENTAL

Iron Folic Acid Tablets with 60 mg of iron

Intervention Type DIETARY_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 iron

Intervention Type 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.

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

Group Type EXPERIMENTAL

Iron Folic Acid Tablets with 60 mg of iron

Intervention Type DIETARY_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 iron

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ifakara Health Institute

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Africa Academy for Public Health

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Emily Smith

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blair Wylie, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Honorati Masanja, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Institute

Alfa Muhihi, PhD

Role: PRINCIPAL_INVESTIGATOR

Africa Academy of Public Health

Andrea Pembe, MD, MMed, PhD, FCOG

Role: PRINCIPAL_INVESTIGATOR

Muhimbili University of Health and Allied Sciences

Emily R Smith, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Christopher R Sudfeld, ScD, ScM

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Central Contacts

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Emily R Smith, ScD, MPH

Role: CONTACT

202-994-3589

Christopher R Sudfeld, ScD, ScM

Role: CONTACT

Other Identifiers

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MIFA-ACT

Identifier Type: -

Identifier Source: org_study_id

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