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Vitamin K Supplementation in Patients on Hemodialysis (VISTA)

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: NCT02324686
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Atrial Fibrillation Drug: vitamin K1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation
Study Start Date : January 2014
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: phytonadione


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324686


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Marisa Battistella University Health Network, Toronto
More Information
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Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02324686    
Other Study ID Numbers: 14-8200
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.
Keywords provided by University Health Network, Toronto:
Warfarin
International Normalized Ratio
Vitamin K
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Vitamin K
Vitamin K 1
Vitamins
Micronutrients
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants