Folic Acid Supplementation in Gambian Primigravidae

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00120822
First received: July 12, 2005
Last updated: July 18, 2005
Last verified: July 2005
  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.

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00120822

Locations
Gambia
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
Investigators
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
Fanasil, pyrimethamine drug combination
Sulfadoxine
Pyrimethamine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014