Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

What Was Tested

This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.

Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert their effect by blocking the recycling of vitamin K.

Vitamin K acts as a co-factor in the posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and matrix-gla protein.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Secondary objective of the study is to investigate changes in carboxylation level of osteocalcin and matrix-gla protein after menaquinone-7 supplementation during the oral anticoagulation treatment period.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Healthy male and female adults between 18 and 45 years of age. Subjects of normal body weight and height according to BMI \< 30. Subject has given written consent to take part in the study.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: subjects with (a history of) of coagulation disorders; subjects with (a history of) metabolic or gastrointestinal disease; subjects using (multi)-vitamin supplements containing vitamin k.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Vitamin D, K2, Magnesium and Zinc study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-09 with completion listed for 2007-12.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: changes in level anticoagulation (time frame: 10 weeks).

It also tracked 1 secondary outcome, for example changes in carboxylation level of osteocalcin and matrix-gla protein.

What This Means in Plain Language

Put simply, this is a not phased trial of Vitamin D, K2, Magnesium and Zinc in 20 people.

Its size is small, so on its own it can only give an early look.

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.