Study protocol of the InterVitaminK trial: a Danish population-based randomised double-blinded placebo-controlled trial of the effects of vitamin K (menaquinone-7) supplementation on cardiovascular, metabolic and bone health

Kampmann FB, Thysen SM, Nielsen CFB, et al. · BMJ Open

A protocol, not a result: the largest general-population MK-7 trial yet mounted is powered at 89% to detect a 15% between-group difference in coronary calcium progression over 3 years, with bone mineral density, lung function and insulin-resistance markers as secondary outcomes. No joint or cartilage endpoint is included.

Population

Danish men and women aged 52-82 with detectable coronary artery calcification but no manifest cardiovascular disease

Intervention

MK-7 333 ug/day for 3 years

Comparator

Placebo

Limitations

Published protocol only — it carries no findings; it is the nearest registered vehicle for a long-term MK-7 outcome trial. Kappa Bioscience supplied funds and the tablets, and the principal investigator has applied for a patent on vitamin K and lung function.