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

This study has been completed.
Sponsor:
Collaborator:
EU: The Fifth Framework Programme
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00267540
First received: December 20, 2005
Last updated: January 29, 2008
Last verified: January 2008
  Purpose

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
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   10 Years to 11 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267540

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

No publications provided by University of Copenhagen

Additional 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
Study First Received: December 20, 2005
Last Updated: January 29, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014