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Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients (iPACKHD)

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. Identifier: NCT01528800
Recruitment Status : Unknown
Verified July 2017 by Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital.
Recruitment status was:  Recruiting
First Posted : February 8, 2012
Last Update Posted : July 25, 2017
Kingston Health Sciences Centre
Information provided by (Responsible Party):
Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital

Brief Summary:
The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo?

Condition or disease Intervention/treatment Phase
Endstage Kidney Disease Drug: Vitamin K1 Drug: Chrystalline Lactose Phase 2

Detailed Description:
At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the 3 major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in incident hemodialysis patients with a baseline CAC score of >= 30 Agatston Units compared to placebo? Secondary questions include: 1) Does phylloquinone reduce the progression of calcification in the thoracic aorta, aortic valve and mitral valve? and 2) Does phylloquinone decrease major cardiovascular events such as acute coronary syndrome, congestive heart failure, stroke, transient ischemic attack, amputation or revascularization procedure?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialyis Patients: iPACKHD Study
Study Start Date : November 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin K

Arm Intervention/treatment
Placebo Comparator: Placebo
Chrystalline Lactose
Drug: Chrystalline Lactose
10mg orally three times a week for 12 months

Active Comparator: Vitamin K1
Vitamin K1
Drug: Vitamin K1
10mg orally three times a week for 12 months
Other Name: phytonadione

Primary Outcome Measures :
  1. Feasibility of recruiting pts to trial/compliance of study intervention over 12 months & drop out rate of study pts/adherence to study protocol/pilot electronic data capture system/logistics of future multi site RCT [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. biomarkers of vitamin K [ Time Frame: baseline; M4; M8; 12 months ]
  2. cardiovascular events [ Time Frame: monthly assessed ]
  3. mortality [ Time Frame: 12 months ]
  4. coronary artery calcification [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • have end stage kidney disease and are new to hemodialysis (< 6 months)
  • >=18 years
  • have a baseline coronary artery calcification score >=30AUs
  • are expected to survive one year
  • are able to provide signed informed consent

Exclusion Criteria:

  • have a medical condition that requires warfarin
  • require hemodialysis for acute kidney injury
  • are pregnant
  • have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year
  • have undergone coronary artery bypass grafting or have stents placed in their coronary arteries
  • are currently enrolled in another interventional trial

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 identifier (NCT number): NCT01528800

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Contact: Rachel Holden 613-533-3134

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Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Rachel Holden         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Deborah Zimmerman         
Sponsors and Collaborators
Dr. Rachel Holden
Kingston Health Sciences Centre
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Principal Investigator: Rachel Holden Queens University or KGH

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Rachel Holden, Assistant Professor of Medicine, Clinical Evaluation Research Unit at Kingston General Hospital Identifier: NCT01528800     History of Changes
Other Study ID Numbers: iPACKHD
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Keywords provided by Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital:
Vitamin K
Chronic kidney disease
vascular calcification
coronary artery calcification
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin K
Vitamin K 1
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action