Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

NCT06079918 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6381

Last updated 2025-07-01

No results posted yet for this study

Summary

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

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 from the time of randomization until delivery.

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 from the time of randomization until delivery.

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 until delivery.

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, MD, MPH · Africa Academy for Public Health

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

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

  • Christopher R Sudfeld, ScD, ScM · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06079918 on ClinicalTrials.gov