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

    rona.smith@doctors.org.uk

  • 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