Vitamin K Supplementation in Patients on Hemodialysis (VISTA)

February 2, 2018 updated by: University Health Network, Toronto

Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation

The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients on hemodialysis with atrial fibrillation are at increased risk of stroke. These patients often take warfarin to reduce this risk. Warfarin is a drug that is used to prevent clots in the bloodstream. The dose of warfarin varies from person to person, and its effect is measured using a blood test called the international normalized ratio (INR). In most patients with atrial fibrillation the goal is to keep the INR between 2 and 3. Patients on hemodialysis often have unstable INR levels. Vitamin K supplementation has been shown to improve INR control in patients on warfarin but has not yet been studied in hemodialysis patients.

In this study, patients on hemodialysis receiving warfarin for atrial fibrillation will receive vitamin K 400 mcg orally three times a week on dialysis days for 4 months. INR levels in the four months before and the four months while receiving vitamin K will be reviewed.

The primary end point will look at INR stability and be measured by calculating the standard deviation of INR values before and after receiving vitamin K. The goal of this study is to determine whether vitamin K supplementation improves INR control in patients on hemodialysis taking warfarin for atrial fibrillation.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • greater than 18 years of age
  • Receiving in-house hemodialysis for at least 6 months
  • Previously diagnosed with atrial fibrillation
  • On warfarin for at least 6 months with a target INR of 2-3

Exclusion Criteria:

  • are unable to provide informed consent
  • have a mechanical heart valve
  • are receiving supplements containing vitamin K
  • have a known hypersensitivity to vitamin K

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vitamin K1
Vitamin K1 400 mcg orally three times a week on dialysis days for four months
Drug: vitamin K1
Vitamin K1 400 mcg orally three times a week on dialysis days for four months
Other Names:
  • phytonadione

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INR stability (standard deviation of INR values)
Time Frame: 4 months before and 4 months after intervention
standard deviation of INR values, 4 months before and 4 months after the intervention
4 months before and 4 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Therapeutic Range (Percentage of time INR levels within range)
Time Frame: 4 months before and 4 months after intervention
, 4 months before and 4 months after the intervention
4 months before and 4 months after intervention
Adverse events
Time Frame: 4 months before and 4 months after intervention
Number and types of thromboembolic and bleeding complications, 4 months before and 4 months after the intervention
4 months before and 4 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Marisa Battistella, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

December 18, 2017

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-8200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

When the study is complete aggregate data of the study will be published and shared. Individual participant data that may identify participants will not be shared. If a participant requests information on his/her individual participant data, it will be provided to the requesting participant.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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