Dose-finding Study for Vitamin K2 in Human Volunteers

What Was Tested

In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

It had seven arms (groups): PLACEBO (placebo comparator), MK7_10 (active comparator), MK7_20 (active comparator), MK7_45 (active comparator) and MK7_90 (active comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

This study is a double-blind randomized intervention study.

Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women).

A double-blind design of the study is chosen to avoid the occurrence of bias during the study.

The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject.

Who Took Part

42 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) metabolic or gastrointestinal disease; subject with (a history of) soy allergy; subjects using vitamin supplements containing vitamin k.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-05 with completion listed for 2007-10.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: undercarboxylated osteocalcin (ucOC) (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example carboxylated osteocalcin (cOC) and undercarboxylated matrix-gla protein (ucMGP).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 42 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.