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

source extracted confidence: high 2026-04-09
#colchicine #diabetes-mellitus-type-2 #double-blind-method #humans #positron-emission-tomography-computed-tomography

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

Bellinge et al., 2022 | J Nucl Cardiol | Rct

Citation

Bellinge Jamie W, Francis Roslyn J, ... Schultz Carl J. 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. J Nucl Cardiol. 2022-Aug;29(4):1855-1866. doi:10.1007/s12350-021-02589-8

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.

Key Findings

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.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population diabetes mellitus and coronary
Sample Size 154
Age Range See abstract
Condition diabetes

MeSH Terms

  • Colchicine
  • Diabetes Mellitus, Type 2
  • Double-Blind Method
  • Humans
  • Positron Emission Tomography Computed Tomography
  • Sodium Fluoride
  • Vascular Calcification
  • Vitamin K 1
  • Vitamins

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: vitamin-k-cardiovascular

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09