- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162409
Relationship Between Folic Acid and Warfarin Metabolism and Effect
The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yoseph Caraco, MD
- Phone Number: 00 972 2 6778584
- Email: caraco@hadassah.org.il
Study Locations
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Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
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Principal Investigator:
- Yoseph Caraco, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients on chronic warfarin therapy
Exclusion Criteria:
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Warfarin pharmacokinetic prior to and following administration of folic acid
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Warfarin dose requirement prior to and following the administration of folic acid.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yc19552-HMO-CTIL
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