Relationship Between Folic Acid and Warfarin Metabolism and Effect

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, October 2008

First Received: September 11, 2005 Last Updated: October 28, 2008 History of Changes

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00162409

Purpose

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	Intervention
Folic Acid Deficiency	Drug: Folic acid

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Dietary Supplements

Drug Information available for: Folic acid Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment:	400
Study Start Date:	August 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients on chronic warfarin therapy

Exclusion Criteria:

Refusal to participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162409

Contacts

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: Yoseph Caraco, MD

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization

More Information

No publications provided

Study ID Numbers:	yc19552-HMO-CTIL
Study First Received:	September 11, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00162409 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Vitamin B Complex
Anticoagulants
Avitaminosis
Hematinics
Folate
Trace Elements
Warfarin
Folinic Acid

Vitamin B9
Folic Acid
Malnutrition
Folic Acid Deficiency
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

Additional relevant MeSH terms:

Anticoagulants
Vitamin B Complex
Vitamin B Deficiency
Hematinics
Avitaminosis
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Warfarin

Pharmacologic Actions
Folic Acid
Malnutrition
Folic Acid Deficiency
Therapeutic Uses
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

ClinicalTrials.gov processed this record on September 11, 2009