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...
Date First Received: September 11, 2005
Last Updated: October 28, 2008
Verified by: Hadassah Medical Organization, October 2008
Clinical Trial Phase: N/A | Start Date: August 2001
Overall Status: Recruiting
Estimated Enrollment: 400
Brief Summary
Official Title: “The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Intervention(s) in this Clinical Trial
- Drug: Folic acid
Outcome Measures for this Clinical Trial
Primary Measures
- Warfarin pharmacokinetic prior to and following administration of folic acid
- Warfarin dose requirement prior to and following the administration of folic acid.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients on chronic warfarin therapy
Exclusion Criteria:
- Refusal to participate in the study
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hadassah Medical Organization
Overall Clinical Trial Officials and Contacts
Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization
Overall Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162409
Study ID Number: yc19552-HMO-CTIL
ClinicalTrials.gov Identifier: NCT00162409
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Clinical Trials Authorship and Review
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