Relationship Between Folic Acid and Warfarin Metabolism a... | NCT00162409

Studies
Relationship Between Folic Acid and Warfarin Metabolism and Effect

NCT00162409

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Oct 29, 2008Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Folic Acid Deficiency

Interventions

Folic acid

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2008

Last Update Posted Date

Oct 29, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
Folic acid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Warfarin pharmacokinetic prior to and following administration of folic acid
Warfarin dose requirement prior to and following the administration of folic acid.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients on chronic warfarin therapy

Exclusion Criteria:

Refusal to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoseph Caraco, MD	Contact	00 972 2 6778584		caraco@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Yoseph Caraco, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D005494	Folic Acid Deficiency

Ancestor Terms

ID	Term
D014804	Vitamin B Deficiency
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005492	Folic Acid

Ancestor Terms

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided