The VitaKids study: the effect of vitamin K supplementation on osteocalcin carboxylation in children.

Completed

Conditions: carboxylering van osteocalcine
vitamin K deficiency in bone
vitamin K shortage in bone
10047635

Registration Number: NL-OMON30424

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Healthy male and female children between 6 and 10 years of age.
- Subjects of normal body weight and height (p3-p97) according to standard Dutch growth charts

Exclusion Criteria

- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects with (a history of) soy allergy
- Subjects presenting chronic inflammatory disease
- Subjects receiving cortico*d treatments
- Subjects using oral anticoagulants

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>The secondary end points are the percentages of change in serum vitamin K<br /><br>levels in relation to lipid metabolism markers from baseline to endpoint in<br /><br>each individual.<br /><br>Furthermore, the percentages of changes in serum BAP and NTX from baseline to<br /><br>endpoint in each individual are considered to be endpoints as well.</p><br>