About
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
Kidney units submit dialysis patient data to the 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.
People need vitamin D to stay healthy. Getting calcium from the diet into bones depends on vitamin D. Low vitamin D levels (vitamin D deficiency) leads to soft bones, fractures, weak muscles, heart and blood pressure problems, and may increase the risks of infections and cancer. People with kidney failure on dialysis often have low vitamin D levels for at least 3 reasons.
| 1. | When kidneys fail, the body is less efficient at making its own vitamin D. | |
| 2. | Foods rich in vitamin D are mostly restricted because of high phosphate or potassium. | |
| 3. | Patients are usually asked to avoid excessive sunlight or wear sunscreen to avoid skin problems such as cancer. |
Natural vitamin D is not usually given to dialysis patients, because doctors used to believe that the body could not use natural vitamin D unless the kidneys were healthy (and for this reason, the packaging of these vitamin D products often advise that they should be not be taken by patients with kidney problems). It turns out that this is not the case: the body does use natural vitamin D even in people who have no kidneys. This is why we now need to test if natural vitamin D is better or worse than the artificial and active forms of vitamin D treatments we currently use.
● The SIMPLIFIED trial aims to determine whether patients on dialysis stay healthier for longer if they take the “natural” form of vitamin D, called Colecalciferol.
● Natural vitamin D is not usually given to dialysis patients, because doctors used to believe that the body could not use natural vitamin D unless the kidneys were healthy. It turns out that this is not the case: the body does use natural vitamin D even in people who have no kidneys. This is why we now need to test if natural vitamin D is better or worse than the artificial and active forms of vitamin D treatments we currently use.
● The SIMPLIFIED trial does not require any extra hospital visits or procedures.
● We will ask you to complete a short questionnaire once every 6 months as long as the study continues. You can choose how to do this – by letter, internet, smartphone/tablet app, or by telephone, either from home or at your dialysis unit.
● For all patients, we will carry out study assessments via the collection of information already collected about you by other organisations, such as: the United Kingdom Renal Registry (UKRR) and NHS Digital (Public Health England).
● The results of this trial will help kidney doctors and nurses to understand whether natural Vitamin D will increase survival in dialysis patients.
● You can withdraw your consent to the SIMPLIFIED Trial at any time without having to give an explanation.
The SIMPLIFIED Participant Information Sheet can be downloaded here: PIS
If you require more details please contact your local SIMPLIFIED team at your dialysis unit.
Data collected in the SIMPLIFIED trial is managed in accordance with the University of Cambridge data protection guidelines.
The University of Cambridge privacy information for research participants can be found here
| File Name | Link |
|---|---|
| SIMPLIFIED 1st Participant Newsletter 20-Nov-2017.pdf | Download |
| SIMPLIFIED 2nd Participant Newsletter 31-Jan-2018.pdf | Download |
| SIMPLIFIED 3rd Participant Newsletter Mar-2018.pdf | Download |
| SIMPLIFIED 4th Participant Newsletter May-2018.pdf | Download |
| SIMPLIFIED 5th Participant Newsletter 26-Jul-2018.pdf | Download |
| SIMPLIFIED 6th Participant Newsletter Nov2018.pdf | Download |
| SIMPLIFIED 7th Participant Newsletter 05Feb2019.pdf | Download |
| SIMPLIFIED 8th Participant Newsletter 30Jul2019.pdf | Download |