Trial from ANZCTR


Trial ID ACTRN12611000199910
Trial Status: Registered
Date Submitted: 28/01/2011
Date Registered: 21/02/2011
Retrospectively registered

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Public title Does cholecalciferol (vitamin D3) improve patient-level outcomes for people with chronic kidney disease on dialysis
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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)
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Secondary ID [1] 1071 0
CRG120700127
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Secondary ID [2] 259647 0
CTN 2008 / 0437
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
25-Hydroxyvitamin D insufficiency and deficiency 243786 0
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chronic kidney disease stage 5D (dialysis) 261052 0
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Condition category: Condition code:
Renal and Urogenital Kidney disease
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259185 259185 0 0
Metabolic and Endocrine Other metabolic disorders
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259195 259195 0 0
Musculoskeletal Other muscular and skeletal disorders
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259196 259196 0 0

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Descriptions 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
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Treatment: drugs 257930 0
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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.
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Control group Placebo
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Primary Outcome: 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).
240855 0
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Timepoint: Baseline to 6 months 240855 0
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Secondary Outcome: 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). 273012 0
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Timepoint: Baseline and 6 months 273012 0
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Secondary Outcome: Quality of life scores (KDQOL 36). 273013 0
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Timepoint: Baseline and 6 months 273013 0
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Secondary Outcome: 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. 273014 0
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Timepoint: Baseline and 6 months 273014 0
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Secondary Outcome: 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.
273015 0
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Timepoint: Baseline and 6 months 273015 0
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Secondary Outcome: 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
273022 0
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Timepoint: Baseline and 6 months 273022 0
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Secondary Outcome: 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.
273023 0
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Timepoint: Baseline and 6 months 273023 0
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Secondary Outcome: 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.
273024 0
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Timepoint: Baseline and 6 months 273024 0
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Key inclusion criteria Patients on satellite haemodialysis for over 12 weeks with levels of 25-hydroxyvitamin D <60 nmol/L.
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer generated allocation
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 1/01/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 62
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2145 3595 0
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Postcode: 2144 3596 0
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Postcode: 2148 3597 0
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Recruitment outside Australia

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Funding Source: Commercial sector/Industry 243687 0
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Name: Roche Products NeoRecormon Unrestricted Research Grant 243687 0
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Address: Roche Pharmaceuticals Pty Ltd
4-10 Inman Road
Dee Why
NSW 2099
243687 0
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Country: Australia 243687 0
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Primary Sponsor Hospital
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Name: Westmead Hospital, Sydney West Area Health Service
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Address: Westmead Hospital
PO Box 533
Wentworthville, NSW
2145
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Country: Australia
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Secondary Sponsor: University 257545 0
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Name: University of Sydney 257545 0
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Address: Westmead Clincial School
C24 - Westmead Hospital
The University of Sydney
NSW 2006 Australia
257545 0
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Country: Australia 257545 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Sydney West Area Health Service Human Research Ethics Committee 260372 0
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Address: Sydney West Area health Service HREC
Westmead Campus
PO Box 533
Wentworthville, NSW
2145
260372 0
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Country: Australia 260372 0
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Approval Date: 27/06/2008 260372 0
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Submitted Date: 260372 0
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HREC: JH/TC HREC 2008/2/4.3(2723) AU RED 071 WMEAD/66 260372 0
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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.
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Trial website
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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)
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Public Notes
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Principal Investigator
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Name: A/Prof Grahame Elder
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Address: Dept. of Renal Medicine, Westmead Hospital Westmead NSW 2145
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Country: Australia
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Tel: 61 2 98456962
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Email: g.elder@garvan.org.au
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Contact person for public queries
Title: A/Prof
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Name: A/Prof Grahame Elder
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Address: Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia
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Country: Australia
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Tel: +61 2 98456962
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Fax: +61 2 96339351
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Email: g.elder@garvan.unsw.edu.au
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Contact person for scientific queries
Title: A/Prof
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Name: A/Prof Grahame Elder
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Address: Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia
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Fax: +61 2 96339351
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Email: g.elder@garvan.unsw.edu.au
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Contact person responsible for updating information
Title:
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Name: A/Prof Grahame Elder
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Address: Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia
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Country: Australia
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Tel: +61 2 98456962
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Fax: +61 2 96339351
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Email: g.elder@garvan.unsw.edu.au
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Addition Cancer fields
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