Does cholecalciferol (vitamin D3) improve patient-level outcomes for people with chronic kidney disease on dialysis
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)
Westmead Hospital, Sydney West Area Health Service
62 participants
Jan 1, 2011
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Patients on satellite haemodialysis for over 12 weeks with levels of 25-hydroxyvitamin D <60 nmol/L.
Exclusion Criteria1
- 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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Interventions
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
Locations(1)
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ACTRN12611000199910