The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls

Vitamin D Deficiency Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267540
• Other study ID #: QLK1-CT-2000-00623
• Status: Completed
• Phase: N/A
• First received: December 20, 2005
• Last updated: January 29, 2008
• Start date: January 2001
• Est. completion date: December 2003

Study information

• Verified date: January 2008
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Behavioral:
• cholecalciferol (D3) (vitamin)

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, The Royal Veterinary and Agricultural University	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Seventh Framework Programme

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
Primary	Bone accretion measured by DXA. Measurement at baseline and after one year.
Primary	Bone turnover measured at baseline, half a year and one year