The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)|
- 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
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||December 2003|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267540
|Department of Human Nutrition, The Royal Veterinary and Agricultural University|
|Frederiksberg, Denmark, DK 1958|
|Principal Investigator:||Christian Mølgaard, MD, PhD||The Royal Veterinary and Agricultural University, Frederiksberg, Denmark|
|Principal Investigator:||Christian Mølgaard, Md, PhD||The Royal Veterinary and Agricultural University, Frederiksberg, Denmark|