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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12611000199910 |
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Date of registration:
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21/02/2011 |
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Primary sponsor: |
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Public title:
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Does cholecalciferol (vitamin D3) improve patient-level outcomes for people with chronic kidney disease on dialysis
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Scientific title:
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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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Date of first enrolment:
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1/01/2011 |
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Target sample size:
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62 |
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Recruitment status: |
Closed: follow-up complete |
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URL:
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http://www.anzctr.org.au/ACTRN12611000199910.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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Australia
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Contacts
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Name:
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A/Prof A/Prof Grahame Elder |
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Address:
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Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia, Australia
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Telephone:
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+61 2 98456962 |
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Email:
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g.elder@garvan.unsw.edu.au |
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Affiliation:
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Name:
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A/Prof A/Prof Grahame Elder |
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Address:
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Department of Renal Medicine, Westmead Hospital, Cnr Hawkesbury and Darcy Rds, Westmead, NSW 2145, Australia, Australia
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Telephone:
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+61 2 98456962 |
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Email:
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g.elder@garvan.unsw.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients on satellite haemodialysis for over 12 weeks with levels of 25-hydroxyvitamin D <60 nmol/L.
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.
Age minimum:
18 Years
Age maximum:
0 No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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25-Hydroxyvitamin D insufficiency and deficiency
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chronic kidney disease stage 5D (dialysis)
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Intervention(s)
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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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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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.
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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.
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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.
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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
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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).
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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.
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Quality of life scores (KDQOL 36).
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Secondary ID(s)
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CRG120700127
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CTN 2008 / 0437
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Source(s) of Monetary Support
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Roche Products NeoRecormon Unrestricted Research Grant
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