Trials / Completed
CompletedNCT00267540
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 225 (planned)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- Female
- Age
- 10 Years – 11 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | cholecalciferol (D3) (vitamin) |
Timeline
- Start date
- 2001-01-01
- Completion
- 2003-12-01
- First posted
- 2005-12-21
- Last updated
- 2008-01-30
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00267540. Inclusion in this directory is not an endorsement.