CompletedPhase 2ACTRN12611001260910

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


Sponsor

Richard Singer

Enrollment

88 participants

Start Date

May 1, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether vitamin D (cholecalciferol) supplements can improve quality of life and muscle strength in people with kidney failure on dialysis. Adults aged 18 and older receiving regular hemodialysis or peritoneal dialysis who have low vitamin D levels are enrolled.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

John Hunter Hospital Royal Newcastle Centre - New Lambton

ACT,NSW, Australia

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ACTRN12611001260910