Comparison of Efficacy of Different Dosages Vitamin K2

What Was Tested

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

Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin.

Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9.

It had five arms (groups): placebo (placebo comparator), vitamin K1 (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose.

The registry classes the interventions as dietary supplement.

More on the Plan

Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 40 years up to 60 years.

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

Examples of who could join: Healthy men and women between 40 and 60 years old. Subjects of normal body weight and height according to BMI \< 30. Subjects of Caucasian race. Subject has given written consent to take part in the study.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: subjects with (a history of) metabolic or gastrointestinal disease; subjects presenting chronic degenerative and/or inflammatory disease; subjects presenting diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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 and investigator.

It started in 2009-10 with completion listed for 2010-02.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form) (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example the number or type of bacteria in the stool.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 82 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.