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Folic Acid Supplementation in Gambian Primigravidae

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120822
First Posted: July 19, 2005
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council Unit, The Gambia
Department of State for Health and Social Welfare, The Gambia
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  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
Intervention Model: Single Group Assignment
Masking: Double
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 Brian Greenwood, London School of Hygiene and Tropical Medicine:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120822


Locations
Gambia
Medical Research Council, Laboratories
Banjul, Gambia, PO Box 273
Sponsors and Collaborators
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

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00120822     History of Changes
Other Study ID Numbers: ITCRVG27a
First Submitted: July 12, 2005
First Posted: July 19, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria
Pregnancy
Folic acid
Sulfadoxine-pyrimethamine

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Folic Acid
Vitamin B Complex
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents


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