VITDALIZE UK: Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency

Plain English Summary

Background and study aims
Vitamin D deficiency (low vitamin D levels) is common in patients who are unwell (around 70%). This has been found to be related to an increased risk of infection and death. There are many reasons why patients are poorly and those who do survive can suffer long-term health problems in the future. 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. There are no guidelines to measure and treat patients admitted to intensive care who are critically ill and are vitamin D deficient. Vitamin D is cheap and easily available, and if using vitamin D is found to help, can be quickly put into standard practice in hospitals. VITDALIZE is an international trial that aims to recruit 2400 patients from across Europe. Countries that are participating include the UK, Austria, Germany and Belgium. The UK part of VITDALIZE aims to recruit 600 patients into the trial. The aim of this trial is to see if giving a high dose of vitamin D in critically ill patients can improve survival, length of hospital stay, and quality of life.

Who can participate?
Males and females aged 18 years and above admitted to ICU who are severely vitamin D deficient

What does the study involve?
Participants will be visited or contacted up to six times (days 0, 5, 12, 28, 90 and 1 year). At the beginning of the trial, participants will be given either a high dose of vitamin D or placebo (dummy supplement) on day 0 and a daily dose of either vitamin D or placebo from day 1 to day 90. On day 5 (if still in the hospital), the research team will take some more blood to see how participants are responding to treatment. On days 0, 28, 90 and after 1 year the research team will contact the participant (either in person if still in hospital or by telephone) to ask a few questions about their health. Participants will be asked to consent to provide some optional blood samples at up to three additional timepoints for future approved research. This would mean providing blood samples (25-30 ml; equivalent to 2 tablespoons) on days 0, 5 and 12.

What are the possible benefits and risks of participating?
There may be no direct benefits of taking part, but the results will lead to the best treatment being offered to patients who are unwell and vitamin D deficient.

Where is the study run from?
Birmingham Clinical Trials Unit at the University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
October 2019 to January 2026

Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme (NIHR HTA) (UK)

Who is the main contact?
1. Dr Dhruv Parekh
d.parekh@bham.ac.uk
2. Serena Dhir
s.dhir@bham.ac.uk

Study website

Contact information

Dr Dhruv Parekh
Scientific

Institute of Inflammation and Ageing
University of Birmingham
Birmingham
B15 2TT
United Kingdom

ORCID ID	0000-0002-1508-8362
Email	d.parekh@bham.ac.uk

Ms Serena Dhir
Scientific

Birmingham Clinical Trials Unit
Public Health Building (Y17)
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0) 121 415 8445
Email	vitdalize@trials.bham.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Medical University of Graz
University/education

Auenbruggerplatz 2
Graz
8036
Austria

Phone	+43 (0)31638582383
Email	karin.amrein@medunigraz.at
Website	http://www.medunigraz.at/en/
"ROR"	https://ror.org/02n0bts35

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

18/03/2025: The following changes were made:
1. Colchester General Hospital was replaced with East Suffolk and North Essex NHS Foundation Trust as a study participating centre.
2. The recruitment end date was changed from 31/03/2025 to 31/01/2026.
17/03/2025: Barnsley Hospital NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust, Colchester General Hospital, Kings College Hospital, Kingston Hospital, Leeds Teaching Hospitals NHS Trust, Northampton General Hospital NHS Trust, The Dudley Group NHS Foundation Trust and Mersey and West Lancashire Teaching Hospitals NHS Trust were added as study participating centres.
16/01/2025: The overall end date was changed from 01/10/2025 to 31/01/2026.
15/01/2025: The recruitment end date was changed from 01/11/2023 to 31/03/2025. Cardiff & Vale University LHB, Bradford Teaching Hospitals NHS Foundation Trust, and University Hospitals Coventry and Warwickshire NHS Trust were removed from the study participating centres. Contact details updated.
12/12/2022: Contact details updated.
11/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2022 to 01/11/2023.
2. The overall trial end date has been changed from 01/10/2024 to 01/10/2025 and the plain English summary updated accordingly.
3. Walsall Healthcare NHS Trust, County Durham and Darlington NHS Foundation Trust, The Dudley Group NHS Foundation Trust, North Bristol NHS Trust, Taunton and Somerset NHS Foundation Trust and Portsmouth Hospitals NHS Trust have been removed from the trial participating centres and Diana, Princess of Wales Hospital, Derriford Hospital, Royal Bournemouth Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Musgrove Park Hospital, Scunthorpe General Hospital, The Royal Oldham Hospital, Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus and Royal Liverpool University Hospital NHS Trust added.
4. The intention to publish date has been changed from 01/10/2025 to 01/10/2026.
23/04/2020: The recruitment start date was changed from 01/01/2021 to 12/04/2021.
20/11/2020: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/10/2020 to 01/01/2021.
3. The publication and dissemination plan was updated.
4. The participant level data was changed from 'Other' to 'Available of request'.
17/09/2020: Trial's existence confirmed by the NIHR.