Format

Send to

Choose Destination
Can J Kidney Health Dis. 2015 May 1;2:17. doi: 10.1186/s40697-015-0053-x. eCollection 2015.

Inhibiting the progression of arterial calcification with vitamin K in HemoDialysis patients (iPACK-HD) trial: rationale and study design for a randomized trial of vitamin K in patients with end stage kidney disease.

Author information

1
Department of Medicine, Queen's University, 3048C Etherington Hall, Kingston, Ontario K7L 3 V6 Canada ; Department of Biomedical and Molecular Science, Queen's University, Kingston, Ontario Canada.
2
USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA USA.
3
Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, Ontario Canada.
4
Department of Medicine, McMaster University, Hamilton, Ontario Canada.
5
Department of Nephrology, University of Ottawa, Ottawa, Ontario Canada.
6
Department of Medicine, Western University, London, Ontario Canada.
7
Department of Biomedical and Molecular Science, Queen's University, Kingston, Ontario Canada.
8
Women's College Research Institute and Department of Endocrinology, University of Toronto, Toronto, Ontario Canada.
9
Department of Medicine, University of Toronto, Toronto, Ontario Canada.
10
Department of Medicine, Tufts University, Boston, MA USA.
11
Department of Medicine, Queen's University, 3048C Etherington Hall, Kingston, Ontario K7L 3 V6 Canada ; Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, Ontario Canada.

Abstract

in English, French

BACKGROUND:

Cardiovascular disease, which is due in part to progressive vascular calcification, is the leading cause of death among patients with end stage kidney disease (ESKD) on dialysis. A role for vitamin K in the prevention of vascular calcification is plausible based on the presence of vitamin K dependent proteins in vascular tissue, including matrix gla protein (MGP). Evidence from animal models and observational studies support a role for vitamin K in the prevention of vascular calcification. A large-scale study is needed to investigate the effect of vitamin K supplementation on the progression of vascular calcification in patients with ESKD, a group at risk for sub-clinical vitamin K deficiency.

METHODS/DESIGN:

We plan a prospective, randomized, double-blind, multicenter controlled trial of incident ESKD patients on hemodialysis in centers within North America. Eligible subjects with a baseline coronary artery calcium score of greater than or equal to 30 Agatston Units, will be randomly assigned to either the treatment group (10 mg of phylloquinone three times per week) or to the control group (placebo administration three times per week). The primary endpoint is the progression of coronary artery calcification defined as a greater than 15% increase in CAC score over baseline after 12 months.

DISCUSSION:

Vitamin K supplementation is a simple, safe and cost-effective nutritional strategy that can easily be integrated into patient care. If vitamin K reduces the progression of coronary artery calcification it may lead to decreased morbidity and mortality in men and women with ESKD.

TRIAL REGISTRATION:

NCT 01528800.

KEYWORDS:

Coronary artery calcification; End stage kidney disease; Hemodialysis; Randomized controlled trial; Vitamin K

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center