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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000199910

Enrollment

Registered

2011-02-21

Start date

2011-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results