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Vitamin K Supplementation in Patients on Hemodialysis (VISTA)

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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

Tracking Information
First Submitted Date  ICMJE December 19, 2014
First Posted Date  ICMJE December 24, 2014
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02324686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin K Supplementation in Patients on Hemodialysis
Official Title  ICMJE Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Failure on Dialysis
  • Atrial Fibrillation
Intervention  ICMJE Drug: vitamin K1
Vitamin K1 400 mcg orally three times a week on dialysis days for four months
Other Name: phytonadione
Study Arms  ICMJE Vitamin K1
Vitamin K1 400 mcg orally three times a week on dialysis days for four months
Intervention: Drug: vitamin K1
Publications *

*   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 2, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2014)
15
Actual Study Completion Date  ICMJE December 18, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02324686
Other Study ID Numbers  ICMJE 14-8200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marisa Battistella University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2016

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