NCT06079918

Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,381 (estimated)
• Sponsor: George Washington University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
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 from the time of randomization until delivery.
DIETARY_SUPPLEMENT	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 from the time of randomization until delivery.
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 until delivery.

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2023-10-12
• Last updated: 2025-07-01

Locations

1 site across 1 country: Tanzania