Cholecalciferol in Patients on Dialysis - SIMPLIFIED
Research type
Research Study
Full title
Survival Improvement with Cholecalciferol in Patients on Dialysis – The SIMPLIFIED Registry Trial
IRAS ID
192416
Contact name
Rona Smith
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eudract number
2015-005003-88
ISRCTN Number
ISRCTN15087616
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
Vitamin D deficiency is common in kidney failure, and is a strong predictor of death from cardiovascular disease, infections and cancer. Dialysis patients typically receive pre-activated vitamin D, since it used to be thought that only the kidneys activate vitamin D. However, this increases blood calcium concentrations and may paradoxically make vitamin D deficiency worse. International treatment guidelines now recommend that kidney patients receive inactive vitamin D (known as cholecalciferol), since we now know that every organ activates vitamin D as required, even in kidney failure. However, this approach has not yet been tested in a trial. We will test whether supplementation with cholecalciferol increases survival in UK dialysis patients.
We will randomly assign adult UK dialysis patients to cholecalciferol or standard care.
We will determine the number of deaths over time in the two groups, to establish whether cholecalciferol improves survival. Whether patients are alive or dead at the end of the study will be determined from the national deaths register. We will also measure any differences in survival free from cardiovascular events, infections and cancers, the three leading causes of death in those on dialysis. We will use questionnaires to compare the quality of life of those in the two groups.
Currently only 68% of patients survive 3 years or more on dialysis. Assuming that this will be the case in the control group, we would need to witness 2200 deaths during the study to determine with a sufficient degree of certainty whether cholecalciferol improves survival. We estimate that this would require the inclusion of 4200 patients, followed for a total study duration of approximately 7 years. Put differently, this trial is designed to detect whether cholecalciferol has a clinically relevant effect by saving 4 or more lives for every 100 patients treated.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0065
Date of REC Opinion
10 Mar 2016
REC opinion
Further Information Favourable Opinion