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Trial registered on ANZCTR


Registration number
ACTRN12611001260910
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
7/12/2011
Date last updated
16/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cholecalciferol Supplementation in Kidney Failure Study: Effect on Quality of Life and Muscle Strength
Scientific title
Cholecalciferol Supplementation in Kidney Failure Study: Effect on Quality of Life and Muscle Strength
Secondary ID [1] 273494 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle weakness in patients with kidney failure 279283 0
Quality of Life in patients with kidney failure 279284 0
Condition category
Condition code
Renal and Urogenital 279481 279481 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Opaque capsule of oral Cholecalciferol 50000units/capsule given weekly for 12 weeks, followed by blinded calcidiol level and dose adjustment based on an algorithm designed to maintain blood calcidiol levels between 80-175nmol/l. Further blinded calcidiol level and dosage adjustment (if necessary) will occur at 24 weeks, with therapy continuing for 52 weeks. To avoid inadvertant unblinding, the number of capsules prescribed will be capped at 3 per week.
Intervention code [1] 283811 0
Treatment: Drugs
Comparator / control treatment
Placebo (opaque capsule containing methylcellulose) given orally once a week for 12 weeks, followed by blinded calcidiol level and dose adjustment based on an algorithm designed to maintain blood calcidiol levels between 80-175nmol/l. Further blinded calcidiol level and dosage adjustment (if necessary) will occur at 24 weeks, with therapy continuing for 52 weeks. To avoid inadvertant unblinding, the number of capsules prescribed will be capped at 3 per week.
Control group
Placebo

Outcomes
Primary outcome [1] 286048 0
Quality of Life, as assessed by completion of the KDQOL-SF version 1.3 instument. (Kidney Diseases Quality of Life Short Form version 1.3)
Timepoint [1] 286048 0
1 year
6 months
3 months
Primary outcome [2] 286049 0
Hand grip strength measured using a Smedley hand dynanometer (Sportstek, Victoria, Australia). Subjects will attempt 3 maximal contrations on each side, in a seated position with the arm hanging by the side and the forearm flexed to 90 degrees and the writst in neutral postition. The best recorded force on each side will be recorded as well s the presence of a current arteriovenous fistula or loop and the handedness of the subject.
Timepoint [2] 286049 0
1 year
6 months
3 months
Secondary outcome [1] 295036 0
serum phosphate. This will be assessed monthly with levels dichotomised as avove, or less than 1.5mmol/l and between group differences assessed by the Fisher Exact Test. Levels will also be assessed as a mean of the monthly recordings over 12 month, and between group comparison by Student t-test.
Timepoint [1] 295036 0
1 year
6 months
3 months
Secondary outcome [2] 295037 0
Serum calcium. This will be assess monthly, as a categorical variable dichotomised as albumin adjusted levels above or less than 2.55mmol/l, with between group comparison using Fisher Exact Test. All Calcium levels greater than 2.55 will be confirmed using measurement of whole blood ionised calcium.
Timepoint [2] 295037 0
monthly for 1 year
Secondary outcome [3] 295038 0
troponin positive acute coronary syndrome episodes. This will be assessed using a standard commercial Troponin I assay. An acute coronary event will be deemed to have occured if there is a consistent clinical presentation with troponin I level recorded as >0.03microgram/liter.
Timepoint [3] 295038 0
1 year
Secondary outcome [4] 295040 0
serum alkaline phosphatase using the Architect commercial laboratory testing platform
Timepoint [4] 295040 0
3, 6, 12 months

Eligibility
Key inclusion criteria
Undergoing maintenance therapy with twice or thrice weekly conventional haemodialysis or receiving peritoneal dialysis. Clinically stable.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Baseline calcidiol level >50nmol/l, baseline hypercalcaemia, chronic granulomatous disorder

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)
Potential subjects identified through hospital database. Allocation is opening of consecutive opaque sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation in balanced blocks, stratified by sex and diabetic status
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 1202 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 7063 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 284284 0
Charities/Societies/Foundations
Name [1] 284284 0
The Canberra Hospital Private Practice Fund
Address [1] 284284 0
PO Box 11, Woden, ACT 2606
Country [1] 284284 0
Australia
Primary sponsor type
Individual
Name
Richard Singer
Address
The Canberra Hospital, Dept Renal Medicine, 77 Yamba Drive, Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 283236 0
Individual
Name [1] 283236 0
Girish Talaulikar
Address [1] 283236 0
The Canberra Hospital, Dept Renal Medicine, 77 Yamba Drive, Garran, ACT 2605
Country [1] 283236 0
Australia
Secondary sponsor category [2] 286305 0
Individual
Name [2] 286305 0
Bobby Chako
Address [2] 286305 0
Renal Unit
Level 3, John Hunter Hospital,
2 Lookout Rd New Lambton Heights
NSW 2305, Australia
Country [2] 286305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286243 0
ACT Government Health Directorate Human Research Ethics Committee
Ethics committee address [1] 286243 0
PO Box 11, Woden, ACT 2606
Ethics committee country [1] 286243 0
Australia
Date submitted for ethics approval [1] 286243 0
Approval date [1] 286243 0
19/09/2011
Ethics approval number [1] 286243 0
ETH.8.11.195

Summary
Brief summary
A one year trial comparing high dose nutritional vitamin D vs placebo that will primarily examine the effect on muscle strength and quality of life in patients with kidney failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33460 0
Dr Richard Francis Singer
Address 33460 0
Renal Unit, The Canberra Hospital, 77 Yamba Drive, Garran, ACT 2605, Australia
Country 33460 0
Australia
Phone 33460 0
+61262442222
Fax 33460 0
+61262444627
Email 33460 0
richard.singer@act.gov.au
Contact person for public queries
Name 16707 0
Dr Richard Singer
Address 16707 0
Renal Unit, The Canberra Hospital, PO Box 11, Woden, ACT 2606
Country 16707 0
Australia
Phone 16707 0
+61262443359
Fax 16707 0
61262444627
Email 16707 0
richard.singer@act.gov.au
Contact person for scientific queries
Name 7635 0
Dr Richard Singer
Address 7635 0
Renal Unit, The Canberra Hospital, PO Box 11, Woden, ACT 2606
Country 7635 0
Australia
Phone 7635 0
+61262443359
Fax 7635 0
61262444627
Email 7635 0
richard.singer@act.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary