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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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study conducted by our department, evidence for a poor vitamin K status of bone during growth in children was found (unpublished data, accepted for publication Pediatric Research, october 2006).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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

osteocalcin vitamin K carboxylation healthy children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

menaquinone 7

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wietse Kuis, PhD MD

Role: PRINCIPAL_INVESTIGATOR

WKZ, UMC Utrecht

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wilhelmina Children's Hospital (WKZ), University Medical Center (UMC) Utrecht

Utrecht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

METC Utrecht: 06/232

Identifier Type: -

Identifier Source: secondary_id

NL14210.000.06