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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)
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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)
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Secondary ID [1]
1182
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Registered Project 421/09
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Universal Trial Number (UTN)
NA
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Trial acronym
LDVD Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Elderly Patients with moderate to severe Vitamin D deficiency
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Condition category
Condition code
Metabolic and Endocrine
256552
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
255673
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Treatment: Drugs
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Comparator / control treatment
Patients will be treated with Cholecalciferol 1000units with 600mg Caltrate(R) daily for 12 weeks
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Percentage of patients with vitamin D level above 75nmol/L at week 12 in the two groups
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Assessment method [1]
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Timepoint [1]
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Vitamin D levels will be taken at baseline and week 12
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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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.
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
1/02/2010
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Actual
1/02/2010
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Date of last participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Alfred Hospital
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Address [1]
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Commercial Road Prahran Victoria 3004
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Hosptial
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Address
Commercial Road Prahran Victoria 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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Monash University
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Address [1]
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381 Royal Parade
Parkville, VIC 3052
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Country [1]
994
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Ethics
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Ethics committee address [1]
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Alfred Hospital
Commercial Road Prahran Victoria 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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16/11/2009
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Approval date [1]
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22/12/2009
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Ethics approval number [1]
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Project 421/09
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Summary
Brief summary
To improve the proportion of elderly patients with moderate to severe vitamin D deficiency reaching target levels above 75nmol/L with the implementation of loading dose vitamin D.
The aim is to test the hypotheses:
Loading dose cholecalciferol 5000units daily will bring higher proportion of patients with moderate to severe deficiency up to target levels(>75nmol/L) compared to 1000units daily.
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Trial website
nil
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
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Ms Cynthia Kam
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Address
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Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
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Country
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Australia
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Phone
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+61390762000
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Cynthia Kam
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Address
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Alfred Hospital
Commercial Road
Prahran Victoria 3004
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Country
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Australia
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Phone
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+613 9076 2061
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Cynthia Kam
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Address
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Alfred Hosptial
Commerical Road
Prahran Victoria 3004
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Country
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Australia
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Phone
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+613 9076 2061
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Fax
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Email
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[email protected]
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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.
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