The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
- Conditions
- Vitamin D Deficiency
- Registration Number
- NCT00267540
- Lead Sponsor
- University of Copenhagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 225
- Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bone turnover measured at baseline, half a year and one year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Human Nutrition, The Royal Veterinary and Agricultural University
🇩🇰Frederiksberg, Denmark