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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Dietary supplement: Iron Folic Acid Tablets with 60 mg of iron; Dietary supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Emily R Smith, ScD, MPH; Phone Number: +1 2029943589; Email: emilysmith@gwu.edu
• Study Contact Backup: Name: Christopher R Sudfeld, ScD, ScM; Email: csudfeld@hsph.harvard.edu

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 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 and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
• Concurrent participation in other nutritional supplementation trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMS with 60 mg of iron first, then IFA with 60 mg of iron; Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months	Dietary supplement: Iron Folic Acid Tablets with 60 mg of iron; 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; 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 from the time of randomization.
Experimental: IFA with 60 mg of iron first, then MMS with 60 mg of iron; Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months	Dietary supplement: Iron Folic Acid Tablets with 60 mg of iron; 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; 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 from the time of randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of formulation	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).	At two months
Acceptability of formulation	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).	At four months
Most preferred formulation	To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking them which supplement they like the best.	At two months
Most preferred formulation	To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking them which supplement they like the best.	At four months
Side Effects of formulation	To assess the occurrence of side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using questionnaires.	At two months
Side Effects of formulation	To assess the occurrence of side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using questionnaires.	At four months
Adherence	Pill count of the number of supplements remaining at the end of two months	At two months
Adherence	Pill count of the number of supplements remaining at the end of four months	At four months
Least preferred formulation	To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking them which supplement they like the least.	At two months
Least preferred formulation	To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking them which supplement they like the least.	At four 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: Alfa Muhihi, PhD, Africa Academy of Public Health; Principal Investigator: Andrea 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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

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): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Iron; Tanzania; Acceptability; IFA; Multiple Micronutrient Supplementation
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Vitamins; Vitamin B Complex; Hematinics; Micronutrients; Trace Elements; Folic Acid; Iron
• Other Study ID Numbers: MMS IFA Crossover

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No