NCT01115478

Malaria in Pregnancy: Nutrition and Immunologic Effects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malaria
• Low Birth Weight
• Anemia
• Perinatal Mortality

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin A	Daily oral dose of 2500 IU from enrollment until delivery
DIETARY_SUPPLEMENT	Zinc	Daily oral dose of 25 mg from enrollment until delivery
OTHER	Placebo	Daily oral dose from enrollment until delivery

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-05-04
• Last updated: 2015-04-24

Locations

1 site across 1 country: Tanzania