Micronutrient supplements to prevent anemia in pregnant women 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
This study tests whether different amounts of iron in micronutrient supplements can help prevent anemia in pregnant women in Tanzania.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 6381 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | George Washington University Academic / other |
| Locations | 1 site (Dar es Salaam) |
| Trial ID | NCT06079918 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of multiple micronutrient supplements (MMS) with varying iron content in preventing moderate to severe anemia among pregnant women in Tanzania. Participants will be randomly assigned to receive MMS containing either 30 mg, 45 mg, or 60 mg of elemental iron. The study aims to determine the optimal iron dosage for maternal health, providing critical data for health policy in Tanzania. The trial will involve pregnant women attending their first antenatal care visit and will track their health outcomes until six weeks post-delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women under 20 weeks gestation, aged 18 years or older, who are planning to stay in Dar es Salaam until six weeks after delivery.
Not a fit: Patients with severe anemia, sickle cell disease, or those currently enrolled in another nutritional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal health and reduced anemia rates among pregnant women in Tanzania.
How similar studies have performed: Previous studies on micronutrient supplementation have shown promising results, indicating that this approach could be effective, though this specific dosage comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dar es Salaam
- Muhimbili University of Health and Allied Sciences — Dar es Salaam, Tanzania (Recruiting)
Study contacts
- Principal investigator: Blair Wylie, MD, MPH — Columbia University
- Study coordinator: Emily R Smith, ScD, MPH
- Email: emilysmith@gwu.edu
- Phone: 202-994-3589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.