Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALcholecalciferol (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.