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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06069869
Other study ID # MMS Dose Crossover
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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