Vitamin K2 Intervention in Patients With Vitamin K Antagonists

What Was Tested

This registered phase 2 trial tested Vitamin D, K2, Magnesium and Zinc.

It had four arms (groups): placebo low VKA (placebo comparator), Placebo high VKA (placebo comparator), Vitamin K2 Low VKA (active comparator) and Vitamin K2 high VKA (active comparator).

Microcrystalline cellulose.

The registry classes the interventions as dietary supplement.

More on the Plan

The level of vitamin K intake will be determined during the study visits using dietary questionnaire.

Who Took Part

Enrollment: 50 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: Treated with anticoagulants. INR range between 2-3.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: regular consumption of dietary supplements susceptible to contain vitamin k; milk intolerant or refusing a daily consumption of dairy product; previous insufficient earlier therapeutic vka follow-up.

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.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

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 2012-02 with completion listed for 2013-04.

It ran at 1 site in France.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: INR (time frame: change from baseline at two months). INR (time frame: change from baseline at four months).

It also tracked 8 secondary outcomes, for example c/uc osteocalcin ratio, FVII from plasma, FII, Plasma vitamin K levels, c/uc osteocalcin ratio and FVII.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vitamin D, K2, Magnesium and Zinc in 50 people.

The trial is marked completed; 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.