A Study of the Effect of Folic Acid Supplementation on the Anti-malarial Action of Sulfadoxine-pyrimethamine When Used for Intermittent Preventive Treatment in Gambian Primigravidae.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.
Study Overview
Brief Summary
Supplementation with folic acid and iron is recommended for pregnant women in order to prevent them from developing anemia. In malaria endemic areas of Africa, the World Health Organization (WHO) now recommends that pregnant women should also be given sulfadoxine-pyrimethamine (SP) once a month after quickening to protect them against malaria which is especially harmful during pregnancy. However, folic acid is an antagonist of SP so there is a possibility that giving folic acid with SP could interfere with the ability of the latter to provide protection against malaria. To investigate this possibility Gambian primigravidae with malaria parasitemia have been given SP and folic acid at the same time or on separate occasions two weeks apart and the ability of SP to cure the malaria infection investigated.
Detailed Description
Objective
The objective of this study is to determine if administration of folic acid to pregnant women at the same time as sulfadoxine-pyrimethamine (SP) is given to prevent malaria interferes with the protective effect of the SP.
Study area
The study was carried out in 14 mother and child health (MCH) clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country. In this area malaria is highly seasonal with an entomological inoculation rate of 10-50 infectious bites per year.
Study population
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primigravid pregnancy > 15 weeks
- •Residence in study area
- •Informed consent
Exclusion Criteria
- •Any serious underlying illness.
- •History of adverse reaction to sulfonamides
Outcomes
Primary Outcomes
Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.
Secondary Outcomes
- The mean haemoglobin 14 days after administration of a single dose of sulfadoxine-pyrimethamine to pregnant women.
- The prevalence of malaria parasitemia 14 days after administration of a dose of sulfadoxine-pyrimethamine to pregnant women.
Investigators
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine