Relationship Between Folic Acid and Warfarin Metabolism and Effect

Folic Acid Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00162409
• Other study ID #: yc19552-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2005
• Last updated: October 28, 2008
• Start date: August 2001

Study information

• Verified date: October 2008
• Source: Hadassah Medical Organization
• Contact: Yoseph Caraco, MD
• Phone: 00 972 2 6778584
• Email: caraco[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients on chronic warfarin therapy

Exclusion Criteria:

• Refusal to participate in the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Folic Acid Deficiency

Intervention

Drug:
• Folic acid

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Warfarin pharmacokinetic prior to and following administration of folic acid
Primary	Warfarin dose requirement prior to and following the administration of folic acid.