Vitamin D Deficiency
Conditions
Keywords
Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls
Brief summary
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13. More specifically the effects on the following parameters will be assessed: * Vitamin D metabolites. * Parathyroid hormone. * Bone turnover. * Bone mineral accretion. * Serum calcium and phosphate. * Renal handling of calcium and phosphate.
Detailed description
This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.
Interventions
BEHAVIORALcholecalciferol (D3) (vitamin)
Sponsors
Seventh Framework Programme
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg
Exclusion criteria
* Any chronical disease with influence on bone mass or turnover * Intake of drugs with influence on bone mass or turnover * Intake of calcium or vitamin D other than the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year. | — |
| Bone accretion measured by DXA. Measurement at baseline and after one year. | — |
| Bone turnover measured at baseline, half a year and one year | — |
Countries
Denmark
Outcome results
None listed