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

June 5, 2008 updated by: UMC Utrecht

The VITAKIDS-Study: The Effect of Vitamin K Supplementation on Osteocalcin Carboxylation in Healthy Children

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study conducted by our department, evidence for a poor vitamin K status of bone during growth in children was found (unpublished data, accepted for publication Pediatric Research, october 2006).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. Before a long-term intervention study is undertaken, it is important to determine the effect of vitamin K administration on osteocalcin carboxylation in this specific population. Although the relationship between increased vitamin K intake and osteocalcin carboxylation was already clearly demonstrated in several adult groups (e.g. healthy adults, postmenopausal women), this has never been shown in children.

Objective of the study:

To study the effect of a vitamin K-containing food supplement (menaquinone 7) on osteocalcin carboxylation in healthy children between 6 and 10 years of age in the Netherlands.

Study design:

Randomised double-blind placebo-controlled intervention study.

Study population:

55 healthy children (boys and girls) between 6 and 10 years, recruited from primary schools.

Intervention:

The subjects are randomised into two groups:

  • placebo group: during 8 weeks, 27 children will receive one tablet of placebo- food supplement per day
  • treatment group: during 8 weeks, 28 children will receive one tablet of food supplement per day containing 45 µg vitamin K2.

Primary study parameters/outcome of the study:

Undercarboxylated (ucOC) and carboxylated (cOC) fractions of osteocalcin will be measured by enzyme-linked immunosorbent assay (ELISA). Both the ucOC fraction and the ucOC/cOC ratio (UCR) are sensitive indicators for the vitamin K status of bone. Elevated levels of UCR are indicative of an inferior vitamin K status of bone. The main study parameters are the mean percentages of change in serum undercarboxylated osteocalcin (ucOC) and UCR from baseline (t=0) to endpoint (t=8 weeks) in both treatment groups.

Secondary study parameters/outcome of the study (if applicable):

The secondary end points are the percentages of change in serum vitamin K levels in relation to lipid metabolism markers from baseline to endpoint in each individual.

Furthermore, the percentages of changes in serum BAP and NTX from baseline to endpoint in each individual are considered to be endpoints as well.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 EA
        • Wilhelmina Children's Hospital (WKZ), University Medical Center (UMC) Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects with (a history of) soy allergy
  • Subjects using vitamin supplements containing vitamin K
  • Subjects presenting chronic inflammatory diseases
  • Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subjects receiving corticoϊd treatment
  • Subjects using oral anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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

Secondary Outcome Measures

Outcome Measure
percentages of change in serum vitamin K levels in relation to lipid metabolism markers from baseline to endpoint in each individual
the percentages of changes in serum BAP and NTX from baseline to endpoint in each individual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Wietse Kuis, PhD MD, WKZ, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

June 10, 2008

Last Update Submitted That Met QC Criteria

June 5, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL14210.000.06
  • METC Utrecht: 06/232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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