Cardiovascular disease (CVD) is one of the leading causes of death worldwide. Vitamin K activates matrix Gla Protein (MGP) - a potent inhibitor of vascular calcification. Low vitamin K status has been associated with coronary artery calcification (CAC) and CVD risk. In the randomized double-blinded placebo-controlled InterVitaminK trial, we aim to investigate whether vitamin K supplementation can decrease risk of CVD in individuals with preexisting CAC.
Effects of vitamin K supplementation on cardiovascular risk: a population-based placebo-controlled randomized study (The InterVitaminK Trial)
Coronary artery calcification (CAC) is a strong predictor of future cardiovascular events and progresses more rapidly in individuals with preexisting CAC. It is estimated that ~50 % of middle-aged adults have detectable CAC, and measures for prevention of progression of CAC are needed.
Research suggests that vitamin K may have protective effects against vascular calcification and CVD. However, the evidence mainly stems from observational studies and randomized controlled trials in patients at high risk of CVD.
The overall aim of the study is to investigate the effects of vitamin K supplementation on cardiovascular risk in individuals from the general population with preexisting CAC. The specific aims are to examine the effect of three years intervention with daily vitamin K2 supplementation on progression of CAC (primary outcome), arterial stiffness, coronary plaque composition, blood pressure and biomarkers of inflammation and lipid- and glucose metabolism.
The InterVitaminK trial is a randomized double-blinded placebo-controlled intervention trial. A total of 450 men and women aged 52–82 years with detectable CAC will be randomized (1:1) to receive capsules with menakinone-7 (MK-7) (333 µg/day) or placebo capsules for 3 years. Health examinations are scheduled at baseline, and after 1-, 2- and 3 years of intervention and include: Cardiac CT-scans (at baseline and 3-year follow-up), measurements of arterial stiffness, blood pressure, lung function, body.
Professor Allan Linneberg, Bispebjerg and Frederiksberg hospital, Center for Clinical Research and Prevention
Chief physician and senior researcher Marie Frimodt-Møller, Dept. of Nephrology, Herlev Hospital / Steno Diabetes Center Copenhagen,