The Effect of Folic Acid on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya
NCT00130065 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2012-09-27
Summary
The purpose of this study is to determine whether folic acid, which is often routinely given to pregnant women to prevent birth defects and anemia, affects the efficacy of sulfadoxine-pyrimethamine, another drug that is routinely given to pregnant women in highly malarious areas, for prevention of the adverse effects of malaria during pregnancy.
Conditions
Interventions
- DRUG
-
Sulfadoxine-pyrimethamine/folic acid
- DRUG
-
Sulfadoxine-pyrimethamine/placebo
Sponsors & Collaborators
-
Kenya Medical Research Institute
collaborator OTHER -
Kenya Ministry of Health
collaborator OTHER_GOV -
Centers for Disease Control and Prevention
lead FED
Principal Investigators
-
Annemieke Van Eijk, M.D., Ph.D. · Centers for Disease Control and Prevention, Kenya Medical Research Institiute
-
Monica Parise, M.D. · Centers for Disease Control and Prevention
-
Laurence Slutsker, M.D. · Centers for Disease Control and Prevention, Kenya Medical Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-30
- Primary Completion
- 2006-02-28
- Completion
- 2006-02-28
Countries
- Kenya
Study Locations
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