Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001069246
Ethics application status
Approved
Date submitted
8/12/2009
Date registered
14/12/2009
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Loading Dose Vitamin D Study: Cholecalciferol 5000units daily compared to 1000units daily for the treatment of moderate to severe vitamin D deficiency in Elderly Patients (LDVD Study)
Scientific title
Loading Dose Vitamin D Study: Cholecalciferol 5000units daily compared to 1000units daily for the treatment of moderate to severe vitamin D deficiency in Elderly Patients (LDVD Study)
Secondary ID [1] 1182 0
Registered Project 421/09
Universal Trial Number (UTN)
NA
Trial acronym
LDVD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly Patients with moderate to severe Vitamin D deficiency 252371 0
Condition category
Condition code
Metabolic and Endocrine 256552 256552 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be treated with Cholecalciferol 5000units orally daily (five tablets) with 600mg Caltrate(R) orally daily (one tablet) for 12 weeks
Intervention code [1] 255673 0
Treatment: Drugs
Comparator / control treatment
Patients will be treated with Cholecalciferol 1000units with 600mg Caltrate(R) daily for 12 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 253437 0
Percentage of patients with vitamin D level above 75nmol/L at week 12 in the two groups
Timepoint [1] 253437 0
Vitamin D levels will be taken at baseline and week 12
Secondary outcome [1] 262566 0
Nil
Timepoint [1] 262566 0
Nil

Eligibility
Key inclusion criteria
All elderly patients above the age of 65 years old admitted to The Alfred, Caulfield, Sandringham Hospital during study period with moderate to severe vitamin D deficiency (<25nmol/L) with risk factors for osteoporosis as per National Prescribing Service (NPS) guidelines.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) less than 10mL/min estimated by Cockcroft Gault formula will be excluded due to their inability to convert cholecalciferol into the activated vitamin D form for use in the body. These patients need to be treated with 1,25 dihydroxyvitamin D.
Patients who have been stabilised on continuous cholecalciferol treatment for more than 6 weeks will be excluded from the trial. Patients who have been on cholecalciferol 1000units or less for a period of less than six weeks treatment would still be considered for enrolment. This is based on the assumption that these patients will not reach steady state due to the long half life of cholecalciferol (~3 weeks).
Patients with swallowing difficulties, currently there are only oral formulations available in Australia therefore it would be not feasible to enrol these patients into the trial.

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 with vitamin D level of less than 25nmol/L will be assessed for patient eligibility into the trial. This information will be provided by Alfred Pathology to the researchers on the days that vitamin D assays are performed in order to allow researchers to ask patients for consent entering this trial.

Verbal and written education of the Loading Dose Vitamin D project will be presented to the patient or carer to obtain consent into the trial. Finalisation of forms to be confirmed with Alfred ethics.

Computer generated block randomisation will prepared by the Michael Bailey (Alfred statistician) with the use of sealed envelops to minimise investigator bias. Clinical Trial Pharmacy will randomise consented subjects to study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Vitamin D levels will be taken at baseline and week 12.
Calcium levels will be obtained at baseline and week 12 to monitor for hypercalcemia due to cholecalciferol treatment.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/02/2010
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256153 0
Hospital
Name [1] 256153 0
Alfred Hospital
Country [1] 256153 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hosptial
Address
Commercial Road Prahran Victoria 3004
Country
Australia
Secondary sponsor category [1] 251493 0
None
Name [1] 251493 0
Address [1] 251493 0
Country [1] 251493 0
Other collaborator category [1] 994 0
University
Name [1] 994 0
Monash University
Address [1] 994 0
381 Royal Parade
Parkville, VIC 3052
Country [1] 994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258254 0
Alfred Ethics
Ethics committee address [1] 258254 0
Ethics committee country [1] 258254 0
Australia
Date submitted for ethics approval [1] 258254 0
16/11/2009
Approval date [1] 258254 0
22/12/2009
Ethics approval number [1] 258254 0
Project 421/09

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

Contacts
Principal investigator
Name 30600 0
Ms Cynthia Kam
Address 30600 0
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country 30600 0
Australia
Phone 30600 0
+61390762000
Fax 30600 0
Email 30600 0
c.kam@alfred.org.au
Contact person for public queries
Name 13847 0
Cynthia Kam
Address 13847 0
Alfred Hospital
Commercial Road
Prahran Victoria 3004
Country 13847 0
Australia
Phone 13847 0
+613 9076 2061
Fax 13847 0
Email 13847 0
C.Kam@alfred.org.au
Contact person for scientific queries
Name 4775 0
Cynthia Kam
Address 4775 0
Alfred Hosptial
Commerical Road
Prahran Victoria 3004
Country 4775 0
Australia
Phone 4775 0
+613 9076 2061
Fax 4775 0
Email 4775 0
C.Kam@alfred.org.au

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.