carboxylering van osteocalcine vitamin K deficiency in bone vitamin K shortage in bone
Conditions
Interventions
The subjects are randomised into two groups:
- placebo group: during 8 weeks, 20 children will receive one tablet of
placebo- food supplement per day
- treatment group: during 8 weeks, 20 children w
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undercarboxylated (ucOC) and carboxylated (cOC) fractions of osteocalcin (Takara, Japan) 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed