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

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a clinical study.

The aim of the InterVitaminK trial is to investigate the effects of vitamin K supplementation (menaquinone-7, MK-7) on cardiovascular, metabolic, respiratory and bone health in a general ageing population with detectable vascular calcification.

Why It Was Studied

The Ethical Committee of the Capital Region (H-21033114) approved the protocol.

Written informed consent is obtained from all participants and the trial is conducted in accordance with the Declaration of Helsinki II.

Who Took Part

The abstract describes 450 men taking part.

PubMed tags the participants as both men and women.

Health examinations include cardiac CT scans, measurements of arterial stiffness, blood pressure, lung function, physical function, muscle strength, anthropometric measures, questionnaires on general health and dietary intake, and blood and urine sampling.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The men were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Neither the men nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

The InterVitaminK trial is a randomised, double-blinded, placebo-controlled, trial.

The primary outcome is progression of CAC from baseline to 3-year follow-up.

Secondary outcomes are bone mineral density, pulmonary function and biomarkers of insulin resistance.

What Was Measured

Topics PubMed links to this paper include Vitamin K, Bone Density, Vitamin K 2, Lung, Coronary Artery Disease, Vascular Calcification and Dietary Supplements.

Author keywords: CARDIOLOGY, Calcium & bone, General endocrinology and NUTRITION & DIETETICS.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 450 men.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2023 (BMJ open), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.