Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

NCT06069869 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: MID-ACT
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acceptability; Multiple Micronutrient Supplementation; Iron; Tanzania

Outcome Measures

Primary Outcomes (1)

• Acceptability of MMS formulations

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

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

Secondary Outcomes (5)

• Most preferred MMS formulation

  At three months (after taking all three regimens)

• Least preferred MMS formulation

  At three months (after taking all three regimens)

• Identification of MMS iron dosage

  At three months (after taking all three regimens)

• Side effects of MMS formulations

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

• Adherence

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

Other Outcomes (7)

• Diarrhea

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

• Heartburn

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

• Constipation

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

Study Arms (6)

MM 30mg; then MMS 45mg; then MMS 60mg

EXPERIMENTAL

Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MM 30mg; then MMS 60mg; then MMS 45mg

EXPERIMENTAL

Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MM 45mg; then MMS 30mg; then MMS 60mg

EXPERIMENTAL

Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MM 45 mg; then MMS 60mg; then MMS 30mg

EXPERIMENTAL

Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MM 60mg; then MMS 30mg; then MMS 45mg

EXPERIMENTAL

Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MM 60mg; then MMS 45mg; then MMS 30mg

EXPERIMENTAL

Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

Interventions

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.

MM 30mg; then MMS 45mg; then MMS 60mg; MM 30mg; then MMS 60mg; then MMS 45mg; MM 45 mg; then MMS 60mg; then MMS 30mg; MM 45mg; then MMS 30mg; then MMS 60mg; MM 60mg; then MMS 30mg; then MMS 45mg; MM 60mg; then MMS 45mg; then MMS 30mg

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.

MM 30mg; then MMS 45mg; then MMS 60mg; MM 30mg; then MMS 60mg; then MMS 45mg; MM 45 mg; then MMS 60mg; then MMS 30mg; MM 45mg; then MMS 30mg; then MMS 60mg; MM 60mg; then MMS 30mg; then MMS 45mg; MM 60mg; then MMS 45mg; then MMS 30mg

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.

MM 30mg; then MMS 45mg; then MMS 60mg; MM 30mg; then MMS 60mg; then MMS 45mg; MM 45 mg; then MMS 60mg; then MMS 30mg; MM 45mg; then MMS 30mg; then MMS 60mg; MM 60mg; then MMS 30mg; then MMS 45mg; MM 60mg; then MMS 45mg; then MMS 30mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Study Officials

• Blair Wylie, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Honorati Masanja, PhD

  Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

• Alfa Muhihi, PhD

  Africa Academy for Public Health

  PRINCIPAL INVESTIGATOR

• Andreas Pembe, MD, MMed, PhD, FCOG

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

• Emily R Smith, ScD, MPH

  The George Washington University

  PRINCIPAL INVESTIGATOR

• Christopher R Sudfeld, ScD, ScM

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 6, 2023
• Study Start: September 26, 2025
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

TA (1)