VITDALIZE UK
Research type
Research Study
Full title
Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D Deficiency The UK arm of an International Multi-Centre, Placebo-Controlled, Phase III Double-Blind trial
IRAS ID
274476
Contact name
Dhruv Parekh
Contact email
Sponsor organisation
Medical Unviersity of Graz
Eudract number
2016-002460-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
17/147/33, NIHR HTA
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
VITDALIZE is an international study that aims to recruit 2400 patients around the world. Countries that are participating includes the UK, Austria, Germany and Belgium. The UK arm of VITDALIZE aims to recruit 600 patients into the trial.
Vitamin D deficiency (low vitamin D levels) is common (around 70%) in patients who are unwell. This has been found to be related to an increased risk of infection and death. There are many reasons why patients are poorly and for those who do survive from being unwell, can suffer long-term health problems.
Every type of cell in the human body has the ability to use vitamin D and traditionally, vitamin D has been thought to be mainly important for bone health. However, the last 20 years of research has revealed important effects of vitamin D on the immune system and health. In addition, help heart and muscle function.
It is not known whether being vitamin D deficient is a cause or effect of being unwell and research into whether vitamin D is useful is not clear. Vitamin D is cheap, safe, and easily available. If using vitamin D is found to help, can be quickly put into standard practice in hospitals.
Patients will be randomised to receive either a high dose of vitamin D or a placebo. They will then receive a daily dose of either vitamin D or placebo for up to 90 days.
The overall aim for the UK arm of VITDALIZE is to conduct a large international randomised controlled trial to determine if treatment with a high dose of vitamin D improves patient outcomes and is cost-effective, in comparison to the placebo in severely vitamin D deficient critically ill patients admitted to an intensive care unit.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0300
Date of REC Opinion
1 Oct 2020
REC opinion
Further Information Favourable Opinion