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

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ClinicalTrials.gov Identifier: NCT00267540
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : January 30, 2008
Seventh Framework Programme
Information provided by:
University of Copenhagen

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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Behavioral: cholecalciferol (D3) (vitamin)

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : January 2001
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Primary Outcome Measures :
  1. Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
  2. Bone accretion measured by DXA. Measurement at baseline and after one year.
  3. Bone turnover measured at baseline, half a year and one year

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00267540     History of Changes
Other Study ID Numbers: QLK1-CT-2000-00623
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 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