Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130065
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-08-12
Brief Title:
The Effect of Folic Acid on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
The Effect of Folic Acid Supplementation on Efficacy of Sulfadoxine-pyrimethamine in Pregnant Women in Western Kenya
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 04 mg or SP and placebo The placebo and the folic acid 04 mg are given for two weeks and then are replaced by folic acid 5 mg
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 04 mg or SP and placebo The placebo and the folic acid 04 mg are given for two weeks and then are replaced by folic acid 5 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UR6-CCU018970 | None | None | None |