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Evidence-Based Supplement Research
Evidence-Based Supplement Research

The effect of vitamin K1 on arterial calcification activity in subjects with diabetes mellitus: a post hoc analysis of a double-blind, randomized, placebo-controlled trial.

  • 2022-01
  • The American journal of clinical nutrition 115(1)
    • Jamie W Bellinge
    • Roslyn J Francis
    • Sing C Lee
    • Nicola P Bondonno
    • Marc Sim
    • Joshua R Lewis
    • Gerald F Watts
    • Carl J Schultz

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 149
Population
individuals with diabetes mellitus and established coronary calcification (coronary calcium score > 10), but without clinical coronary artery disease
Methods
post hoc analysis of a double-blind randomized controlled trial; oral vitamin K1 supplementation (10 mg/d) or placebo for 3 mo; 18F-NaF PET imaging at baseline and follow-up
Blinding
Double-blind
Duration
3 mo
  • Large Human Trial

Background

Coronary and aortic artery calcifications are generally slow to develop, and their burden predicts cardiovascular disease events. In patients with diabetes mellitus, arterial calcification is accelerated and calcification activity can be detected using 18F-sodium fluoride positron emission tomography (18F-NaF PET).

Objectives

We aimed to determine whether vitamin K1 supplementation inhibits arterial calcification activity in individuals with diabetes mellitus.

Methods

This was a post hoc analysis of the ViKCoVaC (effect of Vitamin-K1 and Colchicine on Vascular Calcification activity in subjects with Diabetes Mellitus) double-blind randomized controlled trial conducted in Perth, Western Australia. Individuals with diabetes mellitus and established coronary calcification (coronary calcium score > 10), but without clinical coronary artery disease, underwent baseline 18F-NaF PET imaging, followed by oral vitamin K1 supplementation (10 mg/d) or placebo for 3 mo, after which 18F-NaF PET imaging was repeated. We tested whether individuals randomly assigned to vitamin K1 supplementation had reduced development of new 18F-NaF PET positive lesions within the coronary arteries and aorta.

Results

In total, 149 individuals completed baseline and follow-up imaging studies. Vitamin K1 supplementation independently decreased the odds of developing new 18F-NaF PET positive lesions in the coronary arteries (OR: 0.35; 95% CI: 0.16, 0.78; P = 0.010), aorta (OR: 0.27; 95% CI: 0.08, 0.94; P = 0.040), and in both aortic and coronary arteries (OR: 0.28; 95% CI: 0.13, 0.63; P = 0.002).

Conclusions

In individuals with diabetes mellitus, supplementation with 10 mg vitamin K1/d may prevent the development of newly calcifying lesions within the aorta and the coronary arteries as detected using 18F-NaF PET. Further long-term studies are needed to test this hypothesis.This trial was registered at anzctr.org.au as ACTRN12616000024448.

Research Insights

  • Vitamin K1 supplementation independently decreased the odds of developing new 18F-NaF PET positive lesions in the coronary arteries (OR: 0.35; 95% CI: 0.16, 0.78; P = 0.010), aorta (OR: 0.27; 95% CI: 0.08, 0.94; P = 0.040), and in both aortic and coronary arteries (OR: 0.28; 95% CI: 0.13, 0.63; P = 0.002).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    10 mg/d
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