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Relationship Between Folic Acid and Warfarin Metabolism and Effect

H

Hadassah Medical Center

Status

Unknown

Conditions

Folic Acid Deficiency

Treatments

Drug: Folic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00162409
yc19552-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients on chronic warfarin therapy

Exclusion criteria

  • Refusal to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Yoseph Caraco, MD

Data sourced from clinicaltrials.gov

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