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Relationship Between Folic Acid and Warfarin Metabolism and Effect

Primary Purpose

Folic Acid Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Folic acid

About this trial

This is an interventional treatment trial for Folic Acid Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients on chronic warfarin therapy Exclusion Criteria: Refusal to participate in the study

Sites / Locations

Hadassah Medical OrganizationRecruiting

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00162409

First Posted

September 11, 2005

Last Updated

October 28, 2008

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00162409

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Folic Acid Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Folic acid

Primary Outcome Measure Information:

Title

Warfarin pharmacokinetic prior to and following administration of folic acid

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients on chronic warfarin therapy Exclusion Criteria: Refusal to participate in the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoseph Caraco, MD

Phone

00 972 2 6778584

caraco@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoseph Caraco, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arik Tzukert, DMD

Phone

00 972 2 6776095

arik@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, PhD

Phone

00 972 2 6777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Yoseph Caraco, MD

12. IPD Sharing Statement

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Relationship Between Folic Acid and Warfarin Metabolism and Effect

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