Placebo-controlled, randomized clinical trial of high-dose cholecalciferol in renal dialysis patients: effect on muscle strength and quality of life
Singer R, Chacko B, Talaulikar G, Karpe K, Walters G
Clinical kidney journal · 18 citations
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- University or hospital
- Canberra Hospital Private Practice Fund
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2018-04-24 · Clin Kidney J · vol. 12 · issue 2 · pp. 281–287
- Publisher
- Oxford University Press
- Cited
- 20 citations · more than 62% of similar papers · 0.5× the field average
- References
- 25 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Vitamin D Research Studies · Parathyroid Disorders and Treatments · Dialysis and Renal Disease Management
- Keywords
- Medicine, Cholecalciferol, Placebo, Vitamin D and neurology, Randomized controlled trial, Internal medicine, Grip strength, Dialysis, Kidney disease, Adverse effect, Confidence interval, Parathyroid hormone, Gastroenterology, Urology, Surgery, Calcium
5 authors
From AU
- Richard Francis Singer · correspondingAustralian National University; Canberra Hospital
- Bobby ChackoJohn Hunter Hospital; University of Newcastle Australia
- Girish Sricant TalaulikarAustralian National University; Canberra Hospital
- Krishna M KarpeAustralian National University; Canberra Hospital
- Giles Desmond WaltersAustralian National University; Canberra Hospital
Abstract
Background
The importance of vitamin D sufficiency in deficient dialysis patients is uncertain. This study aimed to determine if high-dose cholecalciferol for 1-year affected symptoms, muscle strength, blood pressure (BP), cardiac ischaemia, parathyroid hormone, calcium or phosphate.
Methods
This was a randomized, double-blind, placebo-controlled trial with 1-year follow-up that enrolled dialysis patients with 25-hydroxy-vitamin D [25(OH)D] concentration 80 nmol/L. The primary objectives were to assess the effect of supplementation on renal-specific symptoms and on hand-grip strength. Symptoms were assessed using the Kidney Disease Quality of Life Short Form and muscle strength with a hand grip-strength dynamometer. Hypothesis testing was by two-group t-test and Wilcoxon rank-sum on an intention-to-treat basis.
Results
In all, 68 participants were randomized and received study medication. Median 12-month plasma 25(OH)D concentration was 119 nmol/L and 37 nmol/L in the cholecalciferol and placebo groups, respectively. There was no statistical difference in primary outcomes at 12 months. Mean symptom scores at 12 months were two lower in the cholecalciferol group (95% confidence interval -10 to 6) and geometric mean grip-strength was 27 kg in both groups. Symptoms, strength, BP, plasma mineral bone parameters and adverse events were not different between the groups at follow-up.
Conclusions
High-dose cholecalciferol in a deficient dialysis population had no effect on muscle strength or symptoms but appears safe.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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