Status:
COMPLETED
The Effect of Folic Acid on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Kenya Medical Research Institute
Kenya Ministry of Health
Conditions:
Malaria
Eligibility:
FEMALE
15-45 years
Phase:
PHASE4
Brief 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, a...
Detailed Description
In malaria endemic areas in sub-Saharan Africa, pregnant women, especially primi- and secundi-gravidae, are more likely to have placental and peripheral parasitemia with Plasmodium falciparum than non...
Eligibility Criteria
Inclusion
- Parasitemia with a parasite density of ≥ 500 parasites/microliter
- Gestational age \> 16 weeks and \< 35 weeks
- Willingness to provide blood samples and participate in HIV counseling and testing
- Available for follow up for the entire study period
- Hemoglobin \> 7 g/dl
- Age 15-45 years
Exclusion
- Use of folate in the last 4 weeks
- Gestational age \<16 weeks or \>35 weeks
- History of an allergy to sulfonamides or other unknown drugs
- Intake of sulfa-containing drugs or 4-aminoquinolones in the previous month
- A urine test positive for sulfa-compounds
- Sickle cell disease
- Concomitant diseases needing treatment with co-trimoxazole or other sulfa-containing drug
- Hemoglobin \< 7 g/dl
- Severe malaria or any other serious medical condition requiring hospitalization and/or additional treatment. Clinical danger signs of severe malaria include prostration, impaired consciousness, respiratory distress, multiple convulsions, circulatory collapse, pulmonary oedema, abnormal bleeding, jaundice, and hemoglobinuria. Laboratory signs of severe malaria include severe anemia (hemoglobin \< 7 g/dl), hypoglycemia, acidosis, hyperlactataemia, hyperparasitaemia (a parasitemia \> 100,000 parasites/µl), and renal impairment
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00130065
Start Date
November 1 2003
End Date
February 1 2006
Last Update
September 27 2012
Active Locations (1)
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1
CDC/Kenya Medical Research Institute
Kisumu, Kenya