Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000299303
Ethics application status
Approved
Date submitted
11/06/2008
Date registered
16/06/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of vitamin D supplementation on bone density in vitamin D insufficient teenagers: randomised controlled trial
Scientific title
The effects of vitamin D supplementation on bone density in vitamin D insufficient teenagers: randomised placebo-controlled trial
Secondary ID [1] 576 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone development 3255 0
Condition category
Condition code
Musculoskeletal 3420 3420 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
150 000 international units (IU) (3 x 50 000 IU vitamin D3 tablets with 3 x identical inert placebo tablets) or 300 000 IU (6 x 50 000 IU vitamin D3 tablets) of vitamin D3 given orally every 6 months for 2 years
Intervention code [1] 2995 0
Prevention
Comparator / control treatment
Oral 6 monthly dose of 6 x inert identical placebo tablets for 2 years.
Control group
Placebo

Outcomes
Primary outcome [1] 4314 0
bone density (femoral neck bone mineral density, lumbar spine bone mineral density and total body bone mineral content) measured by Hologic Delphi bone densitometer
Timepoint [1] 4314 0
baseline, 12 months and 24 months
Secondary outcome [1] 7271 0
quantitative heel ultrasound measured at the heel by Sahara Clinical Bone Sonometer
Timepoint [1] 7271 0
baseline, then 6 monthly until 24 months

Eligibility
Key inclusion criteria
1.healthy adolescents aged 15-17 years
2. mild to moderate vitamin D deficiency (serum 25-hydroxy vitamin D 12.5-50 nmol/L measured in July to October).
3. no known severe renal impairment, malabsorption, pregnancy, or lactation.
4. no clinical signs of rickets.
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. severe vitamin D deficiency (serum 25-hydroxy vitamin D less than 12.5 nmol/l)
2. vitamin D replete i.e. serum 25-hydroxy vitamin D greater than or equal to 50 nmol/L .
3. known severe renal impairment, malabsorption, pregnancy, or lactation.
4. clinical signs of rickets.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Adolescents will be recruited by invitation through their schools. Allocation concealment will be ensured by the use of identical inert placebo, and a security protected central automated allocation procedure. Allocation will be of individual participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will by computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
670
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3477 0
Charities/Societies/Foundations
Name [1] 3477 0
Royal Hobart Hospital Research Foundation
Country [1] 3477 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute
Address
2/199 Macquarie St
Hobart Tasmania
Country
Australia
Secondary sponsor category [1] 3120 0
None
Name [1] 3120 0
Address [1] 3120 0
Country [1] 3120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5507 0
Tasmania Health and Medical Human research ethics Committee
Ethics committee address [1] 5507 0
University of Tasmania
Private Bag 1
Hobart TAS 7001
Ethics committee country [1] 5507 0
Australia
Date submitted for ethics approval [1] 5507 0
14/01/2008
Approval date [1] 5507 0
02/03/2008
Ethics approval number [1] 5507 0
H9854

Summary
Brief summary
Osteoporosis fractures are common, costly and cause significant death and disability. They may be reduced
by improving the amount of bone laid down in childhood. Childhood vitamin D deficiency is common and is
harmful for bone development. The use of vitamin D supplements in children to improve bone health needs
further investigation. This study aims to determine what effect vitamin supplementation has on bone
development in adolescents who have mild to moderate vitamin D deficiency. This will be tested through a
placebo controlled randomised controlled trial of vitamin D supplementation in a sample of mild to
moderately vitamin D deficient adolescents aged 15 to 17 years.
Trial website
none
Trial related presentations / publications
None as yet
Public notes

Contacts
Principal investigator
Name 28663 0
Address 28663 0
Country 28663 0
Phone 28663 0
Fax 28663 0
Email 28663 0
Contact person for public queries
Name 11820 0
Tania Winzenberg
Address 11820 0
Private Bag 23
Hobart TAS 7001
Country 11820 0
Australia
Phone 11820 0
613 62267700
Fax 11820 0
613 62267704
Email 11820 0
[email protected]
Contact person for scientific queries
Name 2748 0
Tania Winzenberg
Address 2748 0
Private Bag 23
Hobart TAS 7001
Country 2748 0
Australia
Phone 2748 0
613 62267700
Fax 2748 0
613 62267704
Email 2748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.