Relationship Between Folic Acid and Warfarin Metabolism and Effect
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00162409|
Recruitment Status : Unknown
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : September 13, 2005
Last Update Posted : October 29, 2008
Folic acid supplementation has been shown previously to be associated with enhanced formation of p-HPPH from phenytoin, a metabolic pathway which is predominantly mediated through the activity of CYP2C9.
The metabolism of S warfarin, the more active enantiomer of warfarin, is also mediated predominantly through the activity of CYP2C9.
The purpose of the present study was to examine the relationship between folic acid concentration and warfarin pharmacokinetic as well as warfarin dose requirement among patients treated by warfarin. In addition the effect of folic acid supplementation (5 mg/d) for 3 weeks on warfarin pharmacokinetic and warfarin dose requirement will be evaluated in the second part of the study.
|Condition or disease||Intervention/treatment||Phase|
|Folic Acid Deficiency||Drug: Folic acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.|
|Study Start Date :||August 2001|
- Warfarin pharmacokinetic prior to and following administration of folic acid
- Warfarin dose requirement prior to and following the administration of folic acid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162409
|Contact: Yoseph Caraco, MD||00 972 2 email@example.com|
|Hadassah Medical Organization||Recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Yoseph Caraco, MD|
|Principal Investigator:||Yoseph Caraco, MD||Hadassah Medical Organization|