Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000503224
Ethics application status
Not yet submitted
Date submitted
17/06/2009
Date registered
23/06/2009
Date last updated
23/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Vitamin D on balance performance in elderly fallers.
Scientific title
Effect of Vitamin D on balance performance in elderly fallers. A double blind randomised control trial.
Universal Trial Number (UTN)
Trial acronym
The ViDaBE Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poor balance in the elderly 237056 0
vitamin D deficiency in the elderly 237057 0
Condition category
Condition code
Injuries and Accidents 237376 237376 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients found to have impaired balance and vitamin D deficiency after assessment in The Nepean Hospital falls and fracture prevention clinic are recruited. Sixty patients (30 cases and 30 controls) fitting the inclusion criteria will be recruited at the Falls and Fractures Clinic, Nepean Hospital. The following parameters will be evaluated at baseline: balance performance measured by our balance rehabilitation unit (BRU), gait parameters (GaitRITE), serum levels of vitamin D, calcium, albumin and parathyroid Hormone (PTH). Patients with poor balance performance and low levels of vitamin D will be then randomised to receive either one intramuscular injection dose of vitamin D3 of 50,000 International Units or 1 ml (Arachitol, Solvay Pharma, India) or one intramuscular injection dose of placebo (1 mL of normal saline). All patients will receive calcium 1,200 mg orally once daily for the duration of the study ( 9 weeks) and commences immediately after the vitamin D3/placebo injection. After three weeks of randomization and treatment, all subjects will attend the standard balance rehabilitation program for six weeks. The program is run by a physiotherapist trained in using the balance rehabilitation unit machine. The program consists of two half hour sessions per week and runs for 6 weeks. Once patients complete 6 weeks of BRU, new balance, gait and serological assessment will be performed. Patients will be unblinded when all patients have completed the 6-week assessment. Patients in the placebo will then be supplemented with high dose vitamin D.
Intervention code [1] 236769 0
Treatment: Drugs
Comparator / control treatment
placebo
Control group
Placebo

Outcomes
Primary outcome [1] 238171 0
Balance performane with the Balance Rehabilitation Unit (BRU)
Timepoint [1] 238171 0
after the six weeks of BRU exercise program (week 9).
Secondary outcome [1] 242461 0
vitamin D levels

repeat blood test (serum vitamin D, PTH, albumin, and Calcium)
Timepoint [1] 242461 0
week 9.
Secondary outcome [2] 242482 0
gait performane assesssed by the gaitRITE
Timepoint [2] 242482 0
week 9

Eligibility
Key inclusion criteria
age 75 or older
impaired balance as determined by the BRU
Vitamin D level <55.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncontrolled thyroid disease
uncontrolled parathyroid disease
parkinsons disease
creatinine clearance <35ml/min
unable to attend BRU sessions
normal BRU parameters

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who are assessed in the falls and fracture prevention clinic and are found to have impaired balance and low vitamin D will be recruited. The research officer will contact these potential participants by phone and appointment arranged to obtain consent. A sample of about sixty patients whose identitiy and details are coded will be fed into a computer software to generate randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237166 0
University
Name [1] 237166 0
The University of Sydney Nepean Medical Research Foundation.
Country [1] 237166 0
Australia
Primary sponsor type
University
Name
The University of Sydney Nepean Medical Research Foundation
Address
The University of Sydney Clinical School
The Nepean Hospital
level 5 South Block
Derby St
penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 4656 0
Hospital
Name [1] 4656 0
Clinical School-Discipline of Geriatric Medicine funds.
Address [1] 4656 0
Geriatric Medicine
Level 1 North Block
The Nepean Hospital
Derby St
Penrith NSW 2751
Country [1] 4656 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239258 0
sydney west area health service human research ethics committee, nepean campus (EC00151)
Ethics committee address [1] 239258 0
Ethics committee country [1] 239258 0
Australia
Date submitted for ethics approval [1] 239258 0
17/06/2009
Approval date [1] 239258 0
Ethics approval number [1] 239258 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29754 0
Address 29754 0
Country 29754 0
Phone 29754 0
Fax 29754 0
Email 29754 0
Contact person for public queries
Name 13001 0
Dr Oddom Demontiero
Address 13001 0
The University of Sydney Clinical School
The Nepean Hospital
Level 5 South Block
PO Box 63
Derby St
Penrith NSW 2751
Country 13001 0
Australia
Phone 13001 0
+61 2 4734 4278
Fax 13001 0
+61 2 4734 1718
Email 13001 0
[email protected]
Contact person for scientific queries
Name 3929 0
A/P Gustavo Duque
Address 3929 0
Sydney Medical School - Nepean Hospital
Level 5 South Block
Derby St
Penrith NSW 2751
Country 3929 0
Australia
Phone 3929 0
+61 2 47344278
Fax 3929 0
+61 2 47341718
Email 3929 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.