Relationship Between Folic Acid and Warfarin Metabolism and Effect

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00162409
• Collaborator: (none)
• Enrollment: 400
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Folic Acid Deficiency	Drug: Folic acid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Folic Acid Concentration and Folic Acid Supplementation on Warfarin Pharmacokinetic and Warfarin Dose Requirement at Steady State.
• Study Start Date: Aug 1, 2001

Outcome Measures

Primary Outcome Measures

1. Warfarin pharmacokinetic prior to and following administration of folic acid []

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients on chronic warfarin therapy

Exclusion Criteria:

• Refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162409
• Other Study ID Numbers: yc19552-HMO-CTIL
• First Posted: Sep 13, 2005
• Last Update Posted: Oct 29, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Folic Acid Deficiency; Folic Acid

Study Results

No Results Posted as of Oct 29, 2008