Relationship Between Folic Acid and Warfarin Metabolism and Effect
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Folic Acid Deficiency
Intervention: Folic acid (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Yoseph Caraco, MD, Principal Investigator, Affiliation: Hadassah Medical Organization
Overall contact:
Yoseph Caraco, MD, Phone: 00 972 2 6778584, Email: caraco@hadassah.org.il
Summary
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.
Clinical Details
Official title: The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Warfarin pharmacokinetic prior to and following administration of folic acidWarfarin dose requirement prior to and following the administration of folic acid.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients on chronic warfarin therapy
Exclusion Criteria:
- Refusal to participate in the study
Locations and Contacts
Yoseph Caraco, MD, Phone: 00 972 2 6778584, Email: caraco@hadassah.org.il
Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Yoseph Caraco, MD, Principal Investigator
Additional Information
Starting date: August 2001
Last updated: October 28, 2008
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