Malaria in Pregnancy: Nutrition and Immunologic Effects (MAL2)

President and Fellows of Harvard College

Status: Completed

Conditions: Anemia; Perinatal Mortality; Malaria; Low Birth Weight

Treatments: Dietary Supplement: Zinc; Dietary Supplement: Vitamin A; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01115478

HD57941-01A2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primigravida or secundigravidae
• At or before 13 weeks of gestation
• HIV-negative
• Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter

Exclusion criteria

• Not primigravida or secundigravidae
• After 13 weeks of gestation
• HIV-positive
• Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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2,500 participants in 4 patient groups, including a placebo group

Vitamin A

Active Comparator group

Treatment:

Dietary Supplement: Vitamin A

Zinc

Active Comparator group

Treatment:

Dietary Supplement: Zinc

Vitamin A + Zinc

Active Comparator group

Treatment:

Dietary Supplement: Vitamin A

Dietary Supplement: Zinc

Placebo

Placebo Comparator group

Treatment:

Other: Placebo