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Active, Not Recruiting

NCT Number: NCT06069869

Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

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 Dar es Salaam 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

Multiple Micronutrient Supplements with 30 mg of elemental iron

Dietary Supplement

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.

Multiple Micronutrient Supplements with 45 mg of elemental iron

Dietary Supplement

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.

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 for one month.

Primary outcomes

  1. Acceptability of MMS formulations

    Time frame: At one month of taking each regimen, up to 3 months

    Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

Secondary outcomes

  1. Most preferred MMS formulation

    Time frame: At three months (after taking all three regimens)

    Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best.

  2. Least preferred MMS formulation

    Time frame: At three months (after taking all three regimens)

    Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the least.

  3. Identification of MMS iron dosage

    Time frame: At three months (after taking all three regimens)

    Percentage of participants that correctly identify their iron dose treatment order

  4. Side effects of MMS formulations

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period

  5. Adherence

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period

Other outcomes

  1. Diarrhea

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported diarrhea symptoms during each intervention period

  2. Heartburn

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported heartburn symptoms during each intervention period

  3. Constipation

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported constipation symptoms during each intervention period

  4. Vomiting

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported vomiting during each intervention period

  5. Nausea

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported nausea symptoms during each intervention period

  6. Leg cramps

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported leg cramp symptoms during each intervention period

  7. Lower back/pelvic pain

    Time frame: At one month of taking each regimen, up to 3 months

    The percentage of patients with self-reported lower back/pelvic painsymptoms during each intervention period

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) Iron Dosages During Pregnancy in Tanzania

Acronym: MID-ACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
May 8, 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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