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

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

cholecalciferol (D3) (vitamin)

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls

Eligibility Criteria

10 Years - 11 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00267540

First Posted

December 20, 2005

Last Updated

January 29, 2008

Sponsor

University of Copenhagen

Collaborators

Seventh Framework Programme

1. Study Identification

Unique Protocol Identification Number

NCT00267540

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Copenhagen

Collaborators

Seventh Framework Programme

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

Keywords

Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

225 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

cholecalciferol (D3) (vitamin)

Primary Outcome Measure Information:

Title

Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.

Title

Bone accretion measured by DXA. Measurement at baseline and after one year.

Title

Bone turnover measured at baseline, half a year and one year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Mølgaard, MD, PhD

Organizational Affiliation

The Royal Veterinary and Agricultural University, Frederiksberg, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Human Nutrition, The Royal Veterinary and Agricultural University

City

Frederiksberg

ZIP/Postal Code

DK 1958

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

21270380

Citation

Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.

Results Reference

derived

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

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