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Recruiting Phase 3 NCT06079918

NCT06079918 Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

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Clinical Trial Summary
NCT ID NCT06079918
Status Recruiting
Phase Phase 3
Sponsor George Washington University
Condition Pregnancy Related
Study Type INTERVENTIONAL
Enrollment 6,381 participants
Start Date 2025-03-03
Primary Completion 2027-03

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Multiple Micronutrient Supplements with 30 mg of elemental ironMultiple Micronutrient Supplements with 45 mg of elemental ironMultiple Micronutrient Supplements with 60 mg of elemental iron

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 6,381 participants in total. It began in 2025-03-03 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Severe anemia (defined as hemoglobin \< 8.5 g/dL per Tanzania standard of care) * Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC * Concurrently enrolled in another nutritional clinical trial * Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Contact & Investigator

Central Contact

Emily R Smith, ScD, MPH

✉ emilysmith@gwu.edu

📞 202-994-3589

Principal Investigator

Blair Wylie, MD, MPH

PRINCIPAL INVESTIGATOR

Columbia University

Frequently Asked Questions

Who can join the NCT06079918 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06079918 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 6,381 participants.

Is NCT06079918 currently recruiting?

Yes, NCT06079918 is actively recruiting participants. Contact the research team at emilysmith@gwu.edu for enrollment information.

Where is the NCT06079918 trial being conducted?

This trial is being conducted at Dar es Salaam, Tanzania.

Who is sponsoring the NCT06079918 clinical trial?

NCT06079918 is sponsored by George Washington University. The principal investigator is Blair Wylie, MD, MPH at Columbia University. The trial plans to enroll 6,381 participants.

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