Prenatal Iron Supplements: Safety and Efficacy in Tanzania
- Conditions
- MalariaAnemia
- Interventions
- Dietary Supplement: IronOther: Placebo
- Registration Number
- NCT01119612
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief Summary
The purpose of this study is to determine safety and efficacy of prenatal iron supplementation in an area of high malaria burden among women who are not anemic or iron deficient.
- Detailed Description
Iron deficiency anemia and malaria are urgent public health problems in sub-Saharan Africa, including Tanzania. There is a paucity of good quality randomized trials assessing the safety and efficacy of iron supplementation in pregnancy, and its effects on perinatal health outcomes. Prenatal iron supplementation is recommended based on its demonstrated benefit in preventing and treating maternal anemia. There is limited data on the efficacy of iron supplementation on pregnancy outcomes, including birth weight. There are also concerns regarding the use of iron supplementation, particularly among non-anemic women. In particular, there is a lack of research on the safety and efficacy of prenatal iron supplementation in developing regions, characterized by extensive burden of iron deficiency, malaria, and other endemic infectious diseases. Evidence from randomized controlled trials is urgently needed to examine the safety and efficacy of iron supplements among pregnant women in malaria endemic regions, particularly among women who are not anemic.
NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1500
- at or before 27 weeks of gestation
- primigravida or secundigravidae
- not anemic (defined as Hb<8.5 g/dL)
- not iron deficient (defined as serum ferritin <12 μg/L)
- HIV-uninfected
- intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.
- After 27 weeks gestation
- not primigravida or secundigravidae
- anemic
- iron deficient
- HIV-infected
- High iron stores at baseline (i.e., serum ferritin >200 μg/L)
- do not intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron Iron - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Infant birth weight Delivery Continuous measurement
Maternal hemoglobin Delivery Continuous measurement
Placental malaria parasite density Delivery Placental malaria parasite density will be defined as number of parasites per μL of blood or 200 white blood cells; the latter will be converted to a count per μL of blood assuming a count of 8000 WBC/μL.
Incidence of placental malaria Delivery Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
- Secondary Outcome Measures
Name Time Method Maternal malaria infection During pregnancy Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
Maternal anemia Delivery Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.
Low birth weight Delivery Low birth weight will be defined as birth weight less than 2500 grams.
Trial Locations
- Locations (1)
Muhimbili University of Health And Allied Sciences
🇹🇿Dar es Salaam, Tanzania