The effect of vitamin-K1 and colchicine on vascular calcification activity in subjects with diabetes mellitus (ViKCoVaC): A double-blind 2x2 factorial randomized controlled trial

Abstract

Background: There is currently no treatment for attenuating progression of arterial calcification. 18F-sodium fluoride positron emission tomography (18F-NaF PET) locates regions of calcification activity. We tested whether vitamin-K1 or colchicine affected arterial calcification activity. Methods: 154 patients with diabetes mellitus and coronary calcification, as detected using computed tomography (CT), were randomized to one of four treatment groups (placebo/placebo, vitamin-K1 [10 mg/day]/placebo, colchicine [0.5 mg/day]/placebo, vitamin-K1 [10 mg/day]/ colchicine [0.5 mg/day]) in a double-blind, placebo-controlled 2x2 factorial trial of three months duration. Change in coronary calcification activity was estimated as a change in coronary maximum tissue-to-background ratio (TBRmax) on 18F-NaF PET. Results: 149 subjects completed follow-up (vitamin-K1: placebo = 73:76 and colchicine: placebo = 73:76). Neither vitamin-K1 nor colchicine had a statistically significant effect on the coronary TBRmax compared with placebo (mean difference for treatment groups 0·00 ± 0·16 and 0·01 ± 0·17, respectively, p > 0.05). There were no serious adverse effects reported with colchicine or vitamin-K1. Conclusions: In patients with type 2 diabetes, neither vitamin-K1 nor colchicine significantly decreases coronary calcification activity, as estimated by 18F-NaF PET, over a period of 3 months. Clinical trial registration: ACTRN12616000024448.

RAS ID

35528

Document Type

Journal Article

Date of Publication

2022

Funding Information

Royal Perth Hospital Research Foundation Australian Government Research Training Program Scholarships University of Western Australia National Health and Medical Research Council

School

School of Medical and Health Sciences

Grant Number

NHMRC Number : 1107474

Grant Link

http://purl.org/au-research/grants/nhmrc/1107474

Copyright

subscription content

Publisher

Springer

Comments

Bellinge, J. W., Francis, R. J., Lee, S. C., Vickery, A., Macdonald, W., Gan, S. K., ... Schultz, C. J. (2022). The effect of vitamin-K1 and colchicine on vascular calcification activity in subjects with diabetes mellitus (ViKCoVaC): A double-blind 2x2 factorial randomized controlled trial. Journal of Nuclear Cardiology, 29(4), 1855-1866. https://doi.org/10.1007/s12350-021-02589-8

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Link to publisher version (DOI)

10.1007/s12350-021-02589-8