Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover 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.

Conditions

• Pregnancy Related

Interventions

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.

Sponsors & Collaborators

• Ifakara Health Institute

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Muhimbili University of Health and Allied Sciences

  collaborator OTHER

• Africa Academy for Public Health

  collaborator OTHER

• Columbia University

  collaborator OTHER

• George Washington University

  lead OTHER

Principal Investigators

• Christopher R Sudfeld, ScD, ScM · Harvard University

• Blair Wylie, MD, MPH · Columbia University

• Honorati Masanja, PhD · Ifakara Health Institute

• Alfa Muhihi, PhD · Africa Academy of Public Health

• Andrea Pembe, MD, MMed, PhD, FCOG · Muhimbili University of Health and Allied Sciences

• Emily R Smith, ScD, MPH · The George Washington University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2026-09-01

Completion

2026-12-31