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Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability?

NCT00990158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2015-05-21

No results posted yet for this study

Summary

Warfarin is highly effective for the prevention of both first and recurrent thrombotic events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are associated with bleeding or thrombotic complications. The importance of maintaining the INR within the desired interval has led to the concept of "time in therapeutic range (TTR)" - the total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin K increases time in the therapeutic range for patients receiving warfarin.

Conditions

Interventions

DRUG

Phytonadione (Vitamin K1)

A daily dose of 150 micrograms of vitamin K medication given orally for a total of 7 months

DRUG

Placebo

A daily dose of matching placebo medication given orally for a total of 7 months

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • University of Western Ontario, Canada

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Mark A Crowther, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990158 on ClinicalTrials.gov