Daily Vitamin K in Patients on Warfarin With Unstable INRs

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287313
First received: February 3, 2006
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Anticoagulants
Warfarin
Drug: Vitamin K

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Number of warfarin adjustments required in each phase
  • Time in therapeutic, sub-, and supra-therapeutic range
  • Variance/SD of INRs for each patient
  • Adherence assessed by pill counts and pharmacy record review
  • Thrombotic/bleeding episodes

Enrollment: 15
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Stroke or TIA within the previous 12 months
  • VTE within the last 3 months
  • Antiphospholipid antibody syndrome
  • Pregnant patients, since warfarin is contraindicated during pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287313

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Stephan Moll, M.D. University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Stephan Moll, MD, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00287313     History of Changes
Other Study ID Numbers: 05-MED-491
Study First Received: February 3, 2006
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Unstable INRs
Warfarin
Vitamin K

Additional relevant MeSH terms:
Vitamins
Vitamin K
Warfarin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on September 18, 2014