The Effect of Folic Acid on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Kenya Medical Research Institute; Kenya Ministry of Health
• Treatments: Fanasil, pyrimethamine drug combination; Folic Acid; Pyrimethamine; Sulfadoxine; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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