Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000338460
Ethics application status
Approved
Date submitted
16/03/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare the effectiveness and safety of an oral low dose and megadose of cholecalciferol treatment in participants with vitamin D deficiency - a real-life comparison pilot study.
Scientific title
A study to compare the effectiveness and safety of an oral low dose and a megadose vitamin D treatment regimens - a real-life comparison pilot study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 1889 0
Condition category
Condition code
Diet and Nutrition 1984 1984 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be oral 50,000 IU cholecalciferol daily for 10 days and then weekly for 3 months.
Intervention code [1] 1238 0
Treatment: Drugs
Comparator / control treatment
The active control will be oral 1000 IU cholecalciferol tablets at a dose of four per day for one month and then one a day for 3 months.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2805 0
Normalisation of serum 25(0H) concentrations to > 50 nmol/L
Timepoint [1] 2805 0
At 3 months
Secondary outcome [1] 4730 0
Safety parameters - serum and urine calcium concentrations.
Timepoint [1] 4730 0
Serum calcium concentrations will be measured at 10 days and 3 months. 24-hour urine calcium concentrations will be measured at 3 months.

Eligibility
Key inclusion criteria
Serum 25(0H) concentration < 50 nmol/L and ability to consent to trial participation.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to either give informed consent or complete the three month study, primary or tertiary hyperparathyroidism or other causes of hypercalcaemia.

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 will be randomised to either high or low dose treatment groups and stratified according to baseline 25(0H)D concentration. Allocation concealment will be achieved by the use of central randomisation by another person using a computer generated table
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software programme. Patients will be randomised to either high or low dose treatment groups and stratified according to baseline 25(0H)D concentration.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2124 0
University
Name [1] 2124 0
University of Melbourne
Country [1] 2124 0
Australia
Primary sponsor type
Individual
Name
Prof. Peter Ebeling
Address
Country
Secondary sponsor category [1] 1931 0
None
Name [1] 1931 0
Nil
Address [1] 1931 0
Country [1] 1931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3917 0
Footscray-Approval given by Melbourne Health HREC
Ethics committee address [1] 3917 0
Ethics committee country [1] 3917 0
Australia
Date submitted for ethics approval [1] 3917 0
Approval date [1] 3917 0
Ethics approval number [1] 3917 0
2006.104
Ethics committee name [2] 3918 0
Sunsine-Approval given by Melbourne Health HREC
Ethics committee address [2] 3918 0
Ethics committee country [2] 3918 0
Australia
Date submitted for ethics approval [2] 3918 0
Approval date [2] 3918 0
Ethics approval number [2] 3918 0
2006.104
Ethics committee name [3] 3919 0
Williamstown-Approval given by Melbourne Health HREC
Ethics committee address [3] 3919 0
Ethics committee country [3] 3919 0
Australia
Date submitted for ethics approval [3] 3919 0
Approval date [3] 3919 0
Ethics approval number [3] 3919 0
2006.104

Summary
Brief summary
This study will compare the effectiveness and safety of an oral low dose and a megadose vitamin D treatment regimen - it will be a real-life dose comparison study. This intervention study will have an active control group. The intervention will be oral 50,000 IU cholecalciferol daily for 10 days and then weekly for 3 months. The active comparator will be lower dose oral 1000 IU cholecalciferol tablets at a dose of four per day for one month and then one a day for 3 months. The outcome will be the numbers of subjects in each group achieving an optimal serum vitamin D level at 3 months. Safety measures will also be studied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36236 0
Address 36236 0
Country 36236 0
Phone 36236 0
Fax 36236 0
Email 36236 0
Contact person for public queries
Name 10427 0
Prof. Peter R. Ebeling
Address 10427 0
Department of Medicine (WH/RMH),
University of Melbourne,
Western Hospital, Footscray
Country 10427 0
Australia
Phone 10427 0
(03) 8345 6429
Fax 10427 0
(03) 9318 1157
Email 10427 0
[email protected]
Contact person for scientific queries
Name 1355 0
Prof Peter R Ebeling
Address 1355 0
Department of Medicine (WH/RMH),
University of Melbourne,
Western Hospital, Footscray
Country 1355 0
Australia
Phone 1355 0
(03) 8345 6429
Fax 1355 0
(03) 9318 1157
Email 1355 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
SourceTitleYear of PublicationDOI
EmbaseEfficacy and safety of oral continuous low-dose versus short-term high-dose vitamin D: A prospective randomised trial conducted in a clinical setting.2010https://dx.doi.org/10.5694/j.1326-5377.2010.tb03702.x
N.B. These documents automatically identified may not have been verified by the study sponsor.