Daily Vitamin K in Patients on Warfarin With Unstable INRs
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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 |
- 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) |
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 |
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| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| 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:
|
Vitamin K Vitamins Warfarin Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses Anticoagulants |
ClinicalTrials.gov processed this record on May 16, 2013