Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial (MID-ACT)

Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MM 30mg; then MMS 45mg; then MMS 60mg; 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; 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.; 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 for one month.; 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 for one month.
Experimental: MM 30mg; then MMS 60mg; then MMS 45mg; 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; 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.; 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 for one month.; 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 for one month.
Experimental: MM 45mg; then MMS 30mg; then MMS 60mg; 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; 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.; 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 for one month.; 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 for one month.
Experimental: MM 45 mg; then MMS 60mg; then MMS 30mg; 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; 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.; 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 for one month.; 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 for one month.
Experimental: MM 60mg; then MMS 30mg; then MMS 45mg; 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; 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.; 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 for one month.; 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 for one month.
Experimental: MM 60mg; then MMS 45mg; then MMS 30mg; 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; 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.; 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 for one month.; 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 for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Most preferred MMS formulation	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.	At three months (after taking all three regimens)
Least preferred MMS formulation	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.	At three months (after taking all three regimens)
Identification of MMS iron dosage	Percentage of participants that correctly identify their iron dose treatment order	At three months (after taking all three regimens)
Side effects of MMS formulations	The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period	At one month of taking each regimen, up to 3 months
Adherence	The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period	At one month of taking each regimen, up to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea	The percentage of patients with self-reported diarrhea symptoms during each intervention period	At one month of taking each regimen, up to 3 months
Heartburn	The percentage of patients with self-reported heartburn symptoms during each intervention period	At one month of taking each regimen, up to 3 months
Constipation	The percentage of patients with self-reported constipation symptoms during each intervention period	At one month of taking each regimen, up to 3 months
Vomiting	The percentage of patients with self-reported vomiting during each intervention period	At one month of taking each regimen, up to 3 months
Nausea	The percentage of patients with self-reported nausea symptoms during each intervention period	At one month of taking each regimen, up to 3 months
Leg cramps	The percentage of patients with self-reported leg cramp symptoms during each intervention period	At one month of taking each regimen, up to 3 months
Lower back/pelvic pain	The percentage of patients with self-reported lower back/pelvic painsymptoms during each intervention period	At one month of taking each regimen, up to 3 months

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Columbia University; Harvard School of Public Health (HSPH); Ifakara Health Institute; Muhimbili University of Health and Allied Sciences; Africa Academy for Public Health
• Investigators: Principal Investigator: Honorati Masanja, PhD, Ifakara Health Institute; Principal Investigator: Blair Wylie, MD, MPH, Columbia University; Principal Investigator: Emily R Smith, ScD, MPH, The George Washington University; Principal Investigator: Christopher R Sudfeld, ScD, ScM, Harvard University; 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

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2025
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Iron; Tanzania; Acceptability; Multiple Micronutrient Supplementation
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Iron; Micronutrients; Trace Elements
• Other Study ID Numbers: MID-ACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: deidentified analytical dataset supporting published research
• IPD Sharing Time Frame: The deidentified analytical dataset supporting published research may be made available anytime after the date of publication and will be avialable indefinitely.
• IPD Sharing Access Criteria: The deidentified analytical dataset supporting published research may be made available following a reasonable request submitted to the study team and completion of relevant ethical approvals and data transfer agreements
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No