Relationship Between Folic Acid and Warfarin Metabolism and Effect - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 11, 2005

Last Updated Date

October 28, 2008

Start Date ^†

August 2001

Current Primary Outcome Measures ^†

Warfarin pharmacokinetic prior to and following administration of folic acid
Warfarin dose requirement prior to and following the administration of folic acid.

Original Primary Outcome Measures ^†

Warfarin pharmacokinetic prior to and following administration of folic acid
Warfarin dose requirement prior to and following the administration of folic acid.

Change History

Complete list of historical versions of study NCT00162409 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Relationship Between Folic Acid and Warfarin Metabolism and Effect

Official Title ^†

The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.

Brief 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^†

Folic Acid Deficiency

Intervention ^†

Drug: Folic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

400

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients on chronic warfarin therapy

Exclusion Criteria:

Refusal to participate in the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162409

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Investigators ^†

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.