Does cholecalciferol (vitamin D3) improve patient-level outcomes for people with chronic kidney disease on dialysis
Phase 4
Completed
- Conditions
- 25-Hydroxyvitamin D insufficiency and deficiencychronic kidney disease stage 5D (dialysis)Renal and Urogenital - Kidney diseaseMetabolic and Endocrine - Other metabolic disordersMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12611000199910
- Lead Sponsor
- Westmead Hospital, Sydney West Area Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in muscle strength between placebo and active treatment arms.<br>Muscle strength is assessed using hand grip and Chatillon dynomometers. <br>Muscle groupls assessed: hip flexors, knee flexors and extensors, elbow flexors and extensors, shoulder abductors, grip strength using standard protocols for testing.<br>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).[Baseline to 6 months]
- Secondary Outcome Measures
Name Time Method