drugset / Trial / NCT00130065
The Effect of Folic Acid on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya
Phase 4
Completed
600 enrolled
Centers for Disease Control and Prevention
Kenya Medical Research Institute · collabKenya Ministry of Health · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2003-11
- Primary completion
- 2006-02
- Completion
- 2006-02
Publications
- Qi YP, Crider KS, Gutman J, Centeno-Tablante E, Fothergill A, Daniels K, Yeung LF, Mai CT, Mehta S, Williams JL, Finkelstein JL. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. Cochrane Database Syst Rev. 2026 Feb 18;2(2):CD014217. doi: 10.1002/14651858.CD014217.pub2.
- van Eijk AM, Ouma PO, Williamson J, Ter Kuile FO, Parise M, Otieno K, Hamel MJ, Ayisi JG, Kariuki S, Kager PA, Slutsker L. Plasma folate level and high-dose folate supplementation predict sulfadoxine-pyrimethamine treatment failure in pregnant women in Western kenya who have uncomplicated malaria. J Infect Dis. 2008 Nov 15;198(10):1550-3. doi: 10.1086/592715.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sulfadoxine-pyrimethamine | Small molecule | — | — |
| Subject | folic acid | Other / unclassified | 0.4 mg | — |
| Subject | folic acid | Other / unclassified | 5 mg | — |