To study the effect of a vitamin K-containing food supplement on osteocalcin carboxylation in healthy children between 6 and 10 years of age in the Netherlands.
ID
Source
Brief title
Condition
- Other condition
- Vitamin related disorders
Synonym
Health condition
carboxylering van osteocalcine
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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children was found (unpublished data, submitted Pediatric Research, May 2006).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.
Study objective
To study the effect of a vitamin K-containing food supplement 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.
Intervention
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 will receive one tablet of food
supplement per day containing 45 µg vitamin K2.
Study burden and risks
This short intervention study will be performed in healthy children because
previous study results show evidence for a poor vitamin K status of bone in
this subject population. The relationship between increased vitamin K intake
and osteocalcin carboxylation has not yet been demonstrated in this group.
The burden for the subjects consists of blood sampling at start and end of
study, preferably in a fasting condition. During 8 weeks, they will ingest a
food supplement daily. The intake of the food supplement will be recorded on a
special vitamin K-calendar by the child, with help of the parents. Three visits
will be planned. The first visit comprises a short physical examination
(length, weight) and a short questionnaire about food habits.
The risks for the subjects are minimal. No adverse effects are to be expected.
The benefit for subjects in the treatment group is adequate dietary suppletion
of vitamin K for 8 weeks
Lundlaan 6
3584 EA Utrecht
Nederland
Lundlaan 6
3584 EA Utrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14210.000.06 |