Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• Attending first ANC visit at study clinics
• Pregnant women \< 20 weeks gestation by last menstrual period (LMP)
• Aged ≥ 18 years old
• Intending to stay in Dar es Salaam until 6 weeks post delivery
• Provides informed consent
Locations
Other Locations
United Republic of Tanzania
Muhimbili University of Health and Allied Sciences
RECRUITING
Dar Es Salaam
Contact Information
Primary
Emily R Smith, ScD, MPH
emilysmith@gwu.edu
202-994-3589
Backup
Christopher R Sudfeld, ScD, ScM
csudfeld@hsph.harvard.edu
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 6381
Treatments
Active_comparator: MMS with 30 mg iron
MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
Experimental: MMS with 45 mg iron
MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Experimental: MMS with 60 mg iron
MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Related Therapeutic Areas
Sponsors
Collaborators: Muhimbili University of Health and Allied Sciences, Columbia University, Harvard School of Public Health (HSPH), Ifakara Health Institute, Africa Academy for Public Health
Leads: George Washington University