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NCT Number: NCT06069856

Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Acceptability of formulation

    Time frame: At two months of taking each regimen

    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).

Secondary outcomes

  1. Most preferred formulation

    Time frame: At four months (after taking both regimens)

    To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.

  2. Side Effects of formulation

    Time frame: At two months of taking each regimen

    To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron

  3. Adherence

    Time frame: At two months of taking each regimen

    Percentage pill count of the number of supplements taken

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher R Sudfeld, ScD, ScM

CONTACT

[email protected]

Emily R Smith, ScD, MPH

CONTACT

[email protected]

202-994-3589

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

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

Registry information

Official study title

Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania

Acronym: MIFA-ACT

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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