The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.

It had two arms (groups): Intervention (experimental) and Placebo (placebo comparator).

Placebo tablet (no active treatment). The placebo tablets will match the intervention treatment in both taste and appearance. Placebo tablets are manufactured by Kappa Bioscience AS, Oslo, Norway.

The registry classes the interventions as dietary supplement.

More on the Plan

However, there is a need for larger studies investigating the potential health effects of vitamin K in the general population.

Objective: The objective of the InterVitaminK trial is to investigate the effects of vitamin K (menaquinone-7, MK-7) supplementation on cardiovascular, metabolic, and bone health.

Methods: The InterVitaminK trial is a double-blinded, placebo-controlled, randomized intervention trial.

Participants from the Inter99 cohort with detectable CAC (Agatson score \>=10) are eligible for the trial.

Who Took Part

Enrollment: 450 actual participants took part.

It was open to people of any sex aged from 50 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Detectable CAC (Agatson score \>=10) assessed by Cardiac Computed Tomography (CT) scan in the Inter99 20-year follow-up study.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: manifest cvd (prior cerebral infarct, prior myocardial infarct, prior percutaneous coronary intervention or prior coronary artery bypass surgery); noise on the ct scan, which complicates an accurate assessment of cac and interpretation of the ct scan. an example is a pacemaker; current treatment with vitamin k antagonist (vka).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-06-21 with completion listed for 2027-01-30.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Total coronary artery calcification (time frame: Baseline to three years of follow-up).

It also tracked 7 secondary outcomes, for example Coronary plaque composition, Arterial stiffness, Blood pressure, Aortic valve calcifications, Bone mineral density and Pulmonary function.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 450 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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