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Relationship Between Folic Acid and Warfarin Metabolism and Effect

NCT ID: NCT00162409

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Brief Summary

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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

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Conditions

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Folic Acid Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Folic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients on chronic warfarin therapy

Exclusion Criteria

* Refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Yoseph Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yoseph Caraco, MD

Role: CONTACT

Phone: 00 972 2 6778584

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

Other Identifiers

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yc19552-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id