The Effect of Vitamin K Supplementation on Osteocalcin Carboxylation in Healthy Children

What Was Tested

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

Background of the study: Results from several studies show that vitamin K has an important function in bone metabolism.

In a previous cross-sectional study conducted by their department, evidence for a poor vitamin K status of bone during growth in children was found (unpublished data, accepted for publication Pediatric Research, october 2006).

These findings justify clinical intervention studies in which bone quality is monitored as a function of long-term vitamin K-supplementation.

The registry classes the interventions as drug.

Who Took Part

55 actual participants took part.

It was open to people of any sex aged from 6 years up to 11 years.

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

Examples of who could join: Healthy prepubertal male and female children. Subjects of normal body weight and height according to standard Dutch growth charts (within p3-p97). Subject and/or parent of 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; subjects 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.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2007-01 with completion listed for 2007-04.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: mean percentages of change in serum undercarboxylated osteocalcin (ucOC) and UCR from baseline (t=0) to endpoint (t=8 weeks) in both treatment groups.

It also tracked 2 secondary outcomes, for example percentages of change in serum vitamin K levels in relation to lipid metabolism markers from baseline to endpoint in each individual and the percentages of changes in serum BAP and NTX from baseline to endpoint in each individual.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 55 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.