Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Received Date † | August 12, 2005 | ||||||||||||
Last Updated Date | November 10, 2005 | ||||||||||||
Start Date † | November 2003 | ||||||||||||
Current Primary Outcome Measures † |
|
||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00130065 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
Effect of HIV serostatus on drug efficacy | ||||||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | The Effect of Folic Acid on Efficacy of Sulfadoxine-Pyrimethamine in Pregnant Women in Western Kenya | ||||||||||||
Official Title † | The Effect of Folic Acid Supplementation on Efficacy of Sulfadoxine-Pyrimethamine in Pregnant Women in Western Kenya | ||||||||||||
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, another drug that is routinely given to pregnant women in highly malarious areas, for prevention of the adverse effects of malaria during pregnancy. |
||||||||||||
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-pregnant women. Adverse consequences of malaria in pregnancy include maternal anemia, and low birth weight of the new born. Low birth weight is known to be the most important risk factor for infant mortality. Intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) during pregnancy can mitigate the adverse effects of malaria in pregnancy and is the current standard of care in areas of high malaria transmission in sub-Saharan Africa, as recommended by the World Health Organization. SP acts by inhibiting parasite enzymes in the metabolism of folic acid. However, in vitro studies indicate that folic acid can antagonize the antimalarial parasite activity of SP. Furthermore, in one West African study, supplementary folic acid compromised the antimalarial efficacy of SP in children with acute malaria aged 6 months to 12 years. Folic acid requirements are increased during pregnancy, and supplementation with folic acid in pregnancy is recommended. Although in most countries a daily supplementation of 400 to 600 micrograms is considered sufficient, for logistical reasons the daily recommended dose in Kenya is 5 mg of folic acid during pregnancy. It is unknown whether folic acid supplementation might compromise the efficacy of IPT with SP in pregnant women living in malaria endemic areas. Several studies have shown that HIV-seropositive pregnant women have a higher risk of malaria than HIV-seronegative pregnant women. In addition, HIV-infected women are more likely to be anemic compared with HIV-uninfected women. A few studies have also shown that HIV-seropositive women do not appear to respond as well to IPT with SP compared to HIV-seronegative pregnant women. In a recent study in pregnant women in Zimbabwe, HIV-infection was a negative predictor of serum folate, and the authors suggested this may be because of reduced intake and absorption, and increased catabolism in HIV-infected pregnant women. Because HIV-seropositive women as a group may have a different folic acid status (and a potential different reaction to folic acid supplementation) than HIV-seronegative women, it is important to assess HIV-status in study participants. It is also important to confirm that no difference exists between HIV-seropositive and HIV-seronegative women in efficacy of SP for clearance of peripheral parasitemia. Comparison: Parasitemic pregnant women are randomized to receive either SP with folic acid 5 mg, or SP with folic acid 0.4 mg, or SP and placebo. The placebo and the folic acid 0.4 mg are given for two weeks, and then are replaced by folic acid 5 mg. |
||||||||||||
Study Phase | Phase IV | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||||||
Condition † | Malaria | ||||||||||||
Intervention † |
|
||||||||||||
Study Arms / Comparison Groups | |||||||||||||
Publications * | 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. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | 600 | ||||||||||||
Completion Date | November 2005 | ||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
Gender | Female | ||||||||||||
Ages | 15 Years to 45 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | Kenya | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00130065 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | UR6-CCU018970 | ||||||||||||
Study Sponsor † | Centers for Disease Control and Prevention | ||||||||||||
Collaborators †† |
|
||||||||||||
Investigators † |
|
||||||||||||
Information Provided By | Centers for Disease Control and Prevention | ||||||||||||
Verification Date | November 2005 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |