Cholecalciferol Supplementation in Kidney Failure Study: Effect on Quality of Life and Muscle Strength

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001260910

Enrollment

Registered

2011-12-07

Start date

2012-05-01

Completion date

2015-04-30

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

A one year trial comparing high dose nutritional vitamin D vs placebo that will primarily examine the effect on muscle strength and quality of life in patients with kidney failure.

Interventions

Opaque capsule of oral Cholecalciferol 50000units/capsule given weekly for 12 weeks, followed by blinded calcidiol level and dose adjustment based on an algorithm designed to maintain blood calcidiol levels between 80-175nmol/l. Further blinded calcidiol level and dosage adjustment (if necessary) will occur at 24 weeks, with therapy continuing for 52 weeks. To avoid inadvertant unblinding, the number of capsules prescribed will be capped at 3 per week.

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

Undergoing maintenance therapy with twice or thrice weekly conventional haemodialysis or receiving peritoneal dialysis. Clinically stable.

Exclusion criteria

Baseline calcidiol level >50nmol/l, baseline hypercalcaemia, chronic granulomatous disorder

Outcome results