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Trial record 1 of 164 for:    warfarin AND Vitamin K
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Daily Vitamin K in Patients on Warfarin With Unstable INRs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287313
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE February 3, 2006
First Posted Date  ICMJE February 6, 2006
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE October 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00287313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Vitamin K in Patients on Warfarin With Unstable INRs
Official Title  ICMJE Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anticoagulants
  • Warfarin
Intervention  ICMJE Drug: Vitamin K
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2006)
15
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287313
Other Study ID Numbers  ICMJE 05-MED-491
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephan Moll, MD, University of North Carolina at Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephan Moll, M.D. University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP