Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267540
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2005-12-20
Brief Title:
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None