Prenatal Iron Supplements: Safety and Efficacy in Tanzania (MAL1)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prenatal Iron Supplements: Safety and Efficacy in Tanzania|
- Incidence of placental malaria [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]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.
- Placental malaria parasite density [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]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.
- Infant birth weight [ Time Frame: Delivery ] [ Designated as safety issue: No ]Continuous measurement
- Maternal hemoglobin [ Time Frame: Delivery ] [ Designated as safety issue: No ]Continuous measurement
- Low birth weight [ Time Frame: Delivery ] [ Designated as safety issue: No ]Low birth weight will be defined as birth weight less than 2500 grams.
- Maternal malaria infection [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
- Maternal anemia [ Time Frame: Delivery ] [ Designated as safety issue: No ]Anemia will be defined as hemoglobin less than 11 g/dl. Severe anemia will be defined as less than 8.5 g/dl.
|Study Start Date:||September 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Iron||
Dietary Supplement: Iron
Daily oral dose of 60 mg from enrollment until delivery
|Placebo Comparator: Placebo||
Daily oral dose from enrollment until delivery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119612
|Muhimbili University of Health And Allied Sciences|
|Dar es Salaam, Tanzania, PO BOX 65001|
|Principal Investigator:||Wafaie W Fawzi, MD, DrPH||Harvard School of Public Health|
|Principal Investigator:||Zul Premji, MD, MSC, PhD||Muhimbili University of Health and Allied Sciences|