Folic Acid Supplementation in Gambian Primigravidae
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Folic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | 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. |
- Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.
- The prevalence of malaria parasitemia 14 days after administration of a dose of sulfadoxine-pyrimethamine to pregnant women.
- The mean haemoglobin 14 days after administration of a single dose of sulfadoxine-pyrimethamine to pregnant women.
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | January 2004 |
Show Detailed Description Eligibility| Genders Eligible for Study: | 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
Contacts and Locations| Gambia | |
| Medical Research Council, Laboratories | |
| Banjul, Gambia, PO Box 273 | |
| Study Chair: | Brian Greenwood, MD | London School of Hygiene and Tropical Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00120822 History of Changes |
| Other Study ID Numbers: | ITCRVG27a |
| Study First Received: | July 12, 2005 |
| Last Updated: | July 18, 2005 |
| Health Authority: | Gambia: Department of State for Health and Social Welfare |
Keywords provided by Gates Malaria Partnership:
|
Malaria Pregnancy Folic acid Sulfadoxine-pyrimethamine |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Folic Acid Vitamin B Complex Hematinics Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Hematologic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on May 19, 2013