Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287313
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2006-02-03
Brief Title:
Daily Vitamin K in Patients on Warfarin With Unstable INRs
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs
Detailed Description:
Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics Eligible subjects will sign an informed consent form and will receive a point-of-care POC INR monitoring device They will undergo 9 weeks of home INR monitoring via the POC device with monthly clinic follow-up They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None