Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000199910
Ethics application status
Approved
Date submitted
28/01/2011
Date registered
21/02/2011
Date last updated
13/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does cholecalciferol (vitamin D3) improve patient-level outcomes for people with chronic kidney disease on dialysis
Scientific title
A randomised placebo controlled trial to assess the effects of therapy with cholecalciferol on biochemical, bone and patient-level outcomes in patients undergoing haemodialysis (chronic kidney disease stage 5D; CKD 5D)
Secondary ID [1] 1071 0
CRG120700127
Secondary ID [2] 259647 0
CTN 2008 / 0437
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
25-Hydroxyvitamin D insufficiency and deficiency 243786 0
chronic kidney disease stage 5D (dialysis) 261052 0
Condition category
Condition code
Renal and Urogenital 259185 259185 0 0
Kidney disease
Metabolic and Endocrine 259195 259195 0 0
Other metabolic disorders
Musculoskeletal 259196 259196 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cholecalciferol liquid (1000 IU/0.2 mls) administered orally at a dose of 50,000 IU (10mls) weekly for 8 weeks and then monthly until 6 months
Intervention code [1] 257930 0
Treatment: Drugs
Comparator / control treatment
placebo; 10 mls of medium-chain triglyceride (MCT) administered orally weekly for 8 weeks and then monthly until 6 months. MCT is the base for the active drug used in this study.
Control group
Placebo

Outcomes
Primary outcome [1] 240855 0
Differences in muscle strength between placebo and active treatment arms.
Muscle strength is assessed using hand grip and Chatillon dynomometers.
Muscle groupls assessed: hip flexors, knee flexors and extensors, elbow flexors and extensors, shoulder abductors, grip strength using standard protocols for testing.
Differences in strength of individual muscle groups and for overall summed musculoskeletal function will be assessed at baseline and 6 months by 2 sample t-test and by comparing percentage change from baseline to 6 months. Test results for musculoskeletal tests will be transformed to z-scores and summed for an overall index of musculoskeletal function measure according to O'Brien (see references).
Timepoint [1] 240855 0
Baseline to 6 months
Secondary outcome [1] 273012 0
Laboratory data: differences between groups in levels of 25OHD, calcitriol, ALP and bone specific ALP, intact-PTH, TRACP-5B, Ca and P. All analyses performed on samples of serum or plasma taken by venesection prior to commencement of dialysis following the longest weekly interdialytic break (3 days).
Timepoint [1] 273012 0
Baseline and 6 months
Secondary outcome [2] 273013 0
Quality of life scores (KDQOL 36).
Timepoint [2] 273013 0
Baseline and 6 months
Secondary outcome [3] 273014 0
Pulse Wave Velocity (an indicator of vascular stiffness). This is assessed as time for pulse wave transmission from the carotid to femoral artery using ultrasound and the SpygmoCor machine.
Timepoint [3] 273014 0
Baseline and 6 months
Secondary outcome [4] 273015 0
Adverse events: hypercalcaemia, hyperphosphataemia, falls, fracture, parathyroidectomy, hospital admission, cardiovascular events, all cause mortality.
The patient's falls diary will be checked monthly.
Levels of calcium and phosphate will be assessed on routine monthly bloods.
Adverse events including surgery, other admissions, medical complications or new symptoms will be assessed by monthly telephone interviews with the attending dialysis nursing staff and for verification, reference to the patient's hospital record.
Timepoint [4] 273015 0
Baseline and 6 months
Secondary outcome [5] 273022 0
Functional testing:
Timed Chair Stands: participants are asked to fold their arms across their chests and to stand up from a sitting position once. If they successfully rise from the chair, they are asked to stand up and sit down five times as quickly as possible
Timepoint [5] 273022 0
Baseline and 6 months
Secondary outcome [6] 273023 0
Functional testing:
Standing balance: subjects are asked to attempt to maintain their feet in the side-by-side, semi-tandem (heel of one foot beside the big toe of the other foot), and tandem (heel of one foot directly in front of the other foot) positions for 10 seconds each. If participant is unable to hold the position for 10 seconds, record result.
Timepoint [6] 273023 0
Baseline and 6 months
Secondary outcome [7] 273024 0
Functional testing:
Six minute walk test: measures the distance covered when subjects are instructed to walk as quickly as they can for 6 minutes on a level course. This test has been used as a measure of cardiovascular exercise capacity.
Timepoint [7] 273024 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Patients on satellite haemodialysis for over 12 weeks with levels of 25-hydroxyvitamin D <60 nmol/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have undergone parathyroidectomy within 3 months or who require treatment with cinacalcet HCl, patients with hypercalcaemia (corected serum calcium > 2.6 mmol/L), or patients who are on treatment with bisphosphonates, or who have unstable medical conditions or are scheduled for major surgery.

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)
Subjects on satellite dialysis are given information on the study approved by the institution HREC and asked if they wish to volunteer.
Random allocation of subjects to treatment with cholecalciferol or to placebo is by 3rd party (pharmacy staff) who are blinded to patient data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3595 0
2145
Recruitment postcode(s) [2] 3596 0
2144
Recruitment postcode(s) [3] 3597 0
2148

Funding & Sponsors
Funding source category [1] 243687 0
Commercial sector/Industry
Name [1] 243687 0
Roche Products NeoRecormon Unrestricted Research Grant
Country [1] 243687 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital, Sydney West Area Health Service
Address
Westmead Hospital
PO Box 533
Wentworthville, NSW
2145
Country
Australia
Secondary sponsor category [1] 257545 0
University
Name [1] 257545 0
University of Sydney
Address [1] 257545 0
Westmead Clincial School
C24 - Westmead Hospital
The University of Sydney
NSW 2006 Australia
Country [1] 257545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260372 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 260372 0
Sydney West Area health Service HREC
Westmead Campus
PO Box 533
Wentworthville, NSW
2145
Ethics committee country [1] 260372 0
Australia
Date submitted for ethics approval [1] 260372 0
Approval date [1] 260372 0
27/06/2008
Ethics approval number [1] 260372 0
JH/TC HREC 2008/2/4.3(2723) AU RED 071 WMEAD/66

Summary
Brief summary
Participants will be randomly assigned to active treatment with oral cholecalciferol using a single (10 ml) dose of 50000 IU weekly for 8 weeks then 50000 IU monthly or identical placebo. Dosing will be under the supervision of dialysis nursing staff at the conclusion of dialysis sessions. Testing at baseline and 6 months will be performed as described above.
Trial website
Trial related presentations / publications
Elder GJ and Hewitt N. 25-Hydroxyvitamin D Levels, Exercise Capacity and Vascular Stiffness in Patients on Dialysis. Federation International Osteoporosis Federation 2nd Asia-Pacific Osteoporosis and Bone Meeting with ANZBMS. September 2011

Hewitt N, O'Connor A, O'Shaughnessy D, Elder GJ. Effects of cholecalciferol on laboratory, functional, vascular and quality of life outcomes in patients on dialysis; a randomised controlled trial. European Calcified Tissue Society meeting, 2012 (ECTS12-1093)
Public notes

Contacts
Principal investigator
Name 30240 0
A/Prof Grahame Elder
Address 30240 0
Dept. of Renal Medicine,
Westmead Hospital
Westmead
NSW 2145
Country 30240 0
Australia
Phone 30240 0
61 2 98456962
Fax 30240 0
Email 30240 0
[email protected]
Contact person for public queries
Name 13487 0
A/Prof Grahame Elder
Address 13487 0
Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia
Country 13487 0
Australia
Phone 13487 0
+61 2 98456962
Fax 13487 0
+61 2 96339351
Email 13487 0
[email protected]
Contact person for scientific queries
Name 4415 0
A/Prof Grahame Elder
Address 4415 0
Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia
Country 4415 0
Australia
Phone 4415 0
+61 2 98456962
Fax 4415 0
+61 2 96339351
Email 4415 0
[email protected]

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