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Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialysis Patients: The iPACK-HD Study
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.
At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification (VC) 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 three 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 prevalent hemodialysis patients with a baseline CAC score of ≥ 30 Agatston Units compared to placebo?
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Kingston Health Sciences Centre: Kingston General Hospital Site
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
November 1, 2012
Primary Completion Date
December 1, 2019
Completion Date
December 1, 2019
Last Updated
June 28, 2021
85
ACTUAL participants
Vitamin K1
DRUG
Microcrystalline Methylcellulose
DRUG
Lead Sponsor
Dr. Rachel Holden
NCT06842927
NCT05656040
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