Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Summary

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Conditions

• Pregnancy Related

Interventions

DIETARY_SUPPLEMENT

Multiple Micronutrient Supplements with 30 mg of elemental iron

MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.

DIETARY_SUPPLEMENT

Multiple Micronutrient Supplements with 45 mg of elemental iron

MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.

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 for one month.

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

• Blair Wylie, MD, MPH · Columbia University

• Honorati Masanja, PhD · Ifakara Health Institute

• Alfa Muhihi, PhD · Africa Academy for Public Health

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

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

• Christopher R Sudfeld, ScD, ScM · Harvard University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-26

Primary Completion

2026-06-24

Completion

2026-06-24

Countries

• Tanzania

Study Locations