Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

NCT06069856 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MIFA-ACT
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnancy Related

Keywords

Acceptability; Multiple Micronutrient Supplementation; Iron; IFA; Tanzania

Outcome Measures

Primary Outcomes (1)

• 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).

  At two months of taking each regimen

Secondary Outcomes (3)

• Most preferred formulation

  At four months (after taking both regimens)

• Side Effects of formulation

  At two months of taking each regimen

• Adherence

  At two months of taking each regimen

Study Arms (2)

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

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

Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

Interventions

Iron Folic Acid Tablets with 60 mg of iron 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

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 iron 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; MMS with 60 mg of iron first, then IFA with 60 mg of iron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): collaborator
• Africa Academy for Public Health: collaborator
• George Washington University: lead
• Ifakara Health Institute: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator
• Columbia University: collaborator

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Blair Wylie, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Honorati Masanja, PhD

  Ifakara Health Institute

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily R Smith, ScD, MPH

CONTACT

202-994-3589; emilysmith@gwu.edu

Christopher R Sudfeld, ScD, ScM

CONTACT

csudfeld@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open label)
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 6, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02