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

• Published in: Journal of nuclear cardiology Vol. 29; no. 4; pp. 1855 - 1866
• Main Authors: Bellinge, Jamie W., Francis, Roslyn J, Lee, Sing Ching, Vickery, Alistair, Macdonald, William, Gan, Seng Khee, Chew, Gerard T., Phillips, Michael, Lewis, Joshua R., Watts, Gerald F., Schultz, Carl J.
• Format: Journal Article
• Language: English
• Published: Cham Elsevier Inc 01.08.2022; Springer International Publishing; Springer Nature B.V
• Subjects: Calcification; Cardiology; Colchicine; Diabetes; Double-blind studies; Imaging; Medicine; Medicine & Public Health; Molecular Imaging; Nuclear Medicine; Original Article; Radiology; Tomography; Vitamin-K; TBR; Molecular Imaging; ROI; CVD; CT; Vitamin-K; CCS; 18F-NaF; Calcification; Colchicine; MBq; MDS; PET
• ISSN: 1071-3581; 1532-6551; 1532-6551
• DOI: 10.1007/s12350-021-02589-8

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. 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. 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. 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.