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

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00267540
• Collaborator: Seventh Framework Programme (Other)
• Enrollment: 225
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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	Phase
Vitamin D Deficiency	Behavioral: cholecalciferol (D3) (vitamin)	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2001
• Study Completion Date: Dec 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 11 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Human Nutrition, The Royal Veterinary and Agricultural University	Frederiksberg		Denmark	DK 1958

Sponsors and Collaborators

• University of Copenhagen
• Seventh Framework Programme

Investigators

• Principal Investigator: Christian Mølgaard, MD, PhD, The Royal Veterinary and Agricultural University, Frederiksberg, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00267540
• Other Study ID Numbers: QLK1-CT-2000-00623
• First Posted: Dec 21, 2005
• Last Update Posted: Jan 30, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: 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; Cholecalciferol; Vitamin D

Study Results

No Results Posted as of Jan 30, 2008