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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069856
• Other study ID #: MMS IFA Crossover
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2025
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: George Washington University
• Contact: Emily R Smith, ScD, MPH
• Phone: +1 2029943589
• Email: emilysmith[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
George Washington University	Africa Academy for Public Health, Columbia University, Harvard School of Public Health (HSPH), Ifakara Health Institute, Muhimbili University of Health and Allied Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adherence	Pill count of the number of supplements remaining at the end of two months	At two months
Primary	Adherence	Pill count of the number of supplements remaining at the end of four months	At four months
Primary	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
Primary	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