Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000243617
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
31/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D and bone health in persons with intellectual disability
Scientific title
Vitamin D and bone health in persons with intellectual disability
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
 329 0
Vitamin D deficiency 330 0
Condition category
Condition code
Musculoskeletal 379 379 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Vitamin D3 (cholecalciferol)
Intervention code [1] 233 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 437 0
Vitamin D levels
Timepoint [1] 437 0
Measured in all participants as a baseline. In those found to be deficient, vitamin D level measurements are repeated after the supplement has been administered.
Secondary outcome [1] 966 0
Fractures
Timepoint [1] 966 0

Eligibility
Key inclusion criteria
People with intellectual disability who are cared for via Strathmont Centre, Adelaide.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
337
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 434 0
University
Name [1] 434 0
Universty of Adelaide grant
Country [1] 434 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 352 0
None
Name [1] 352 0
None
Address [1] 352 0
Country [1] 352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1403 0
Strathmont Centre
Ethics committee address [1] 1403 0
Ethics committee country [1] 1403 0
Australia
Date submitted for ethics approval [1] 1403 0
Approval date [1] 1403 0
Ethics approval number [1] 1403 0

Summary
Brief summary
This study aims to quantify the prevalence of fractures and of vitamin D deficiency in people with intellectual disability, and to measure the effectiveness of vitamin D replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35390 0
Address 35390 0
Country 35390 0
Phone 35390 0
Fax 35390 0
Email 35390 0
Contact person for public queries
Name 9422 0
Dr Simon Vanlint
Address 9422 0
Department of General Practice
Spencer Gulf Rural Health School
University of Adelaide
Level 3
Eleanor Harrald Bldg
Adelaide SA 5005
Country 9422 0
Australia
Phone 9422 0
+61 8 83034634
Fax 9422 0
+61 8 83033511
Email 9422 0
[email protected]
Contact person for scientific queries
Name 350 0
Dr Simon Vanlint
Address 350 0
Department of General Practice
Spencer Gulf Rural Health School
University of Adelaide
Level 3
Eleanor Harrald Bldg
Adelaide SA 5005
Country 350 0
Australia
Phone 350 0
+61 8 83034634
Fax 350 0
+61 8 83033511
Email 350 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.