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

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00402974
First received: November 21, 2006
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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study conducted by our department, evidence for a poor vitamin K status of bone during growth in children was found (unpublished data, accepted for publication Pediatric Research, october 2006).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


Condition Intervention
Healthy
Drug: menaquinone 7

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The VITAKIDS-Study: The Effect of Vitamin K Supplementation on Osteocalcin Carboxylation in Healthy Children

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 55
Study Start Date: January 2007
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402974

Locations
Netherlands
Wilhelmina Children's Hospital (WKZ), University Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584 EA
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Wietse Kuis, PhD MD WKZ, UMC Utrecht
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00402974     History of Changes
Other Study ID Numbers: NL14210.000.06, METC Utrecht: 06/232
Study First Received: November 21, 2006
Last Updated: June 5, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
osteocalcin
vitamin K
carboxylation
healthy children

Additional relevant MeSH terms:
Vitamin K
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014