Status:

NOT_YET_RECRUITING

Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

Lead Sponsor:

George Washington University

Collaborating Sponsors:

Ifakara Health Institute

Harvard School of Public Health (HSPH)

Conditions:

Pregnancy Related

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT06069856

Start Date

January 1 2026

End Date

July 1 2026

Last Update

June 24 2025

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