NCT00120822

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

July 12, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

MalariaPregnancyFolic acidSulfadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

Folic acidDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primigravid pregnancy \> 15 weeks
  • Residence in study area
  • Informed consent

You may not qualify if:

  • Any serious underlying illness.
  • History of adverse reaction to sulfonamides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council, Laboratories

Banjul, PO Box 273, The Gambia

Location

MeSH Terms

Conditions

Malaria

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Brian Greenwood, MD

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Start

July 1, 2002

Study Completion

January 1, 2004

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

TH(1)