Simplified clinical trial

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SIMPLIFIED is an open-label, pragmatic, randomised registry trial of colecalciferol (“native” or “natural” Vitamin D) versus standard care in patients receiving dialysis. Dialysis patients often receive pre-activated vitamin D preparations (e.g. alfacalcidol, calcitriol or paricalcitol), but supplementing vitamin D stores with colecalciferol may be a better way of keeping dialysis patients healthy. This trial will test whether treatment of dialysis patients with colecalciferol improves survival, quality of life and other health outcomes.

The SIMPLIFIED trial is funded by the National Institute of Health Research Health Technology Assessment Agency

The UK Renal Registry

Kidney units submit dialysis patient data to the UK Renal Registry. This information is used to ensure that units delivery quality dialysis care. Patients participating in the SIMPLIFIED trial are asked to agree to their data being made available to the research team. In this way, information about the effects of colecalciferol can be collected without having to call patients in for lots of extra study visits. SIMPLIFIED is the the first trial of this kind in the United Kingdom.