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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravid pregnancy > 15 weeks
- •Residence in study area
- •Informed consent
排除标准
- •Any serious underlying illness.
- •History of adverse reaction to sulfonamides
结局指标
主要结局
Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.
次要结局
- 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.
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine