Prenatal Iron Supplements: Safety and Efficacy in Tanzania (MAL1)

President and Fellows of Harvard College

Status

Completed

Conditions

Anemia

Malaria

Treatments

Dietary Supplement: Iron

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01119612

HD061232

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.