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

This study has been completed.
Seventh Framework Programme
Information provided by:
University of Copenhagen Identifier:
First received: December 20, 2005
Last updated: January 29, 2008
Last verified: January 2008

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.

Condition Intervention
Vitamin D Deficiency Behavioral: cholecalciferol (D3) (vitamin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 225
Study Start Date: January 2001
Estimated Study Completion Date: December 2003
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.

Ages Eligible for Study:   10 Years to 11 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00267540

Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, Denmark, DK 1958
Sponsors and Collaborators
University of Copenhagen
Seventh Framework Programme
Principal Investigator: Christian Mølgaard, MD, PhD The Royal Veterinary and Agricultural University, Frederiksberg, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00267540     History of Changes
Other Study ID Numbers: QLK1-CT-2000-00623
Study First Received: December 20, 2005
Last Updated: January 29, 2008

Keywords provided by University of Copenhagen:
Vitamin D
adolescent girls
bone accretion
bone turn over
vitamin D status
Vitamin D insufficiency in young girls

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on June 22, 2017