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Relationship Between Folic Acid and Warfarin Metabolism and Effect - Article


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Valproic Acid Injection

Depacon; Valproate Sodium


Clinical Trial: Relationship Between Folic Acid and Warfarin Metabolism and Effect

This study is currently recruiting patients.
Verified by Hadassah Medical Organization August 2004

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00162409

Purpose

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 enantioner 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 Intervention
Folic Acid Deficiency
  Drug: Folic acid

MedlinePlus related topics:  Folic Acid

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

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

Further Study Details: 
Primary Outcomes: Warfarin pharmacokinetic prior to and following administration of folic acid; Warfarin dose requirement prior to and following the administration of folic acid.
Expected Total Enrollment:  400

Study start: August 2001

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Refusal to participate in the study

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00162409

Yoseph Caraco, MD      00 972 2 6778584    caraco@hadassah.org.il

Israel
      Hadassah Medical Organization, Jerusalem,  Israel; Recruiting
Arik Tzukert, DMD  00 972 2 6776095    arik@hadassah.org.il 
Hadas Lemberg, PhD  00 972 2 6777572    lhadas@hadassah.org.il 
Yoseph Caraco, MD,  Principal Investigator

Study chairs or principal investigators

Yoseph Caraco, MD,  Principal Investigator,  Hadassah Medical Organization   

More Information

Study ID Numbers:  17-15/12/00
Last Updated:  September 12, 2005
Record first received:  September 11, 2005
ClinicalTrials.gov Identifier:  NCT00162409
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: June 1, 2005
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