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

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University of Copenhagen

Status

Completed

Conditions

Vitamin D Deficiency

Treatments

Behavioral: cholecalciferol (D3) (vitamin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00267540
QLK1-CT-2000-00623

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

10 to 11 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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