Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, DK 1958, Denmark
Completed
NCT Number: NCT00267540
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.
Completed
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Notify MeKey information
Conditions
Age range
10 year–11 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
cholecalciferol (D3) (vitamin)
BehavioralPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Copenhagen
Other
Collaborators
- Seventh Framework Programme
Registry information
Official study 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)
Important dates
- Study start
- 2001
- Study completion
- 2003
- First posted
- Dec 21, 2005
- Registry last updated
- Jan 30, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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