Anemia Clinical Trial
Official title:
Malaria in Pregnancy: Nutrition and Immunologic Effects
The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.
Malaria accounts for a major proportion of the disease burden in Tanzania with 14 to 18
million new malaria cases being reported each year resulting in 100,000-125,000 deaths.
Malaria results in impaired productivity for those between 15-55 years and lost learning
opportunities in the 5-25 year age group. Dar es Salaam is characterized as an area with
endemic and perennial malaria, with transmission occurring during the entire year. P.
falciparum accounts for more than 95% of malaria infections. A number of interventions have
contributed to reducing the burden of the disease in some settings in Tanzania and beyond,
including vector control measures, bed nets, and prophylaxis and treatment of malaria.
However, malaria remains a serious problem among pregnant women and children. We will
examine the efficacy of micronutrient supplements as a means of enhancing immune response to
malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. If
successful, such a low-cost intervention would be added to the armamentarium against this
disease.
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: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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