Anemia Clinical Trial
Official title:
Prenatal Iron Supplements: Safety and Efficacy in Tanzania
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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