Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Folic Acid Supplementation in Gambian Primigravidae

This study has been completed.
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
Department of State for Health and Social Welfare, The Gambia
Information provided by:
Gates Malaria Partnership Identifier:
First received: July 12, 2005
Last updated: July 18, 2005
Last verified: July 2005
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
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.

Resource links provided by NLM:

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Clearance of malaria parasitemia in parasitemic pregnant women 14 days after treatment with sulfadoxine-pyrimethamine.

Secondary Outcome Measures:
  • 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


Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00120822

Medical Research Council, Laboratories
Banjul, Gambia, PO Box 273
Sponsors and Collaborators
Gates Malaria Partnership
London School of Hygiene and Tropical Medicine
Medical Research Council Unit, The Gambia
Department of State for Health and Social Welfare, The Gambia
Study Chair: Brian Greenwood, MD London School of Hygiene and Tropical Medicine
  More Information 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:
Folic acid

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Folic Acid
Vitamin B Complex
Fanasil, pyrimethamine drug combination
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016