Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069869
• Other study ID #: MMS Dose Crossover
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2025
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• 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 cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• 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 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 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:
• 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.
• 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.
• 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.

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 MMS formulations	To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).	At one month
Secondary	Most preferred MMS formulation	To assess participated reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking them which supplement they like the best.	At three months
Secondary	Side effects of MMS formulations	To assess the occurance of side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires	At one month
Secondary	Adherence	Pill count of the number of supplements remaining at the end of one month	At one month
Secondary	Least preferred MMS formulation	To assess participated reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking them which supplement they like the least.	At three months