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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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cholecalciferol (D3) (vitamin)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

11 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Christian Mølgaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Royal Veterinary and Agricultural University, Frederiksberg, Denmark

Locations

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Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED

PMID: 21270380 (View on PubMed)

Other Identifiers

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QLK1-CT-2000-00623

Identifier Type: -

Identifier Source: org_study_id