Daily Vitamin K in Patients on Warfarin With Unstable INRs

University of North Carolina (UNC)

Status

Completed

Conditions

Anticoagulants

Warfarin

Treatments

Drug: Vitamin K

Study type

Interventional

Funder types

Other

Identifiers

NCT00287313

05-MED-491

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin
Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3
Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator
Age greater than or equal to 18 years

Exclusion criteria