RecruitingPHASE3INTERVENTIONAL

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

The VITDALIZE study is investigating if giving a high dose of vitamin D3 (cholecalciferol) can improve the health of adults who are critically ill and in intensive care. Previous research in a similar study, called VITdAL-ICU, found that while vitamin D didn't shorten hospital stays overall, it did seem to significantly reduce the risk of death within 28 days for patients who had very low levels of vitamin D at the start. This new study aims to confirm that finding. If successful, vitamin D could become a widely used and inexpensive treatment for severely ill patients with vitamin D deficiency, helping to improve their chances of survival. The study involves giving either vitamin D or a dummy treatment (placebo) to patients and carefully monitoring their progress.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Medical University of Graz

Enrolment target

2,400

Start

10 Oct 2017

Estimated completion

01 Mar 2027

Critical Illness Vitamin D Deficiency Covid19

What is this study about?

When people become very unwell and need to go into intensive care (ICU), their bodies are under immense stress. Scientists are always looking for ways to help these patients recover and improve their chances of survival. One area of interest is vitamin D, which plays many important roles in the body, including supporting the immune system.

A previous study, called VITdAL-ICU, looked at giving a large dose of vitamin D3 to critically ill adults. Overall, it didn't reduce how long people stayed in hospital. However, when the researchers looked closely at a group of patients who started the study with very low levels of vitamin D, they found something promising. For these specific patients, those who received the high-dose vitamin D were less likely to die within 28 days compared to those who received a dummy treatment (placebo).

Because this finding was limited to a smaller group within the earlier study, it needs to be properly checked in a larger, new study. That's why the VITDALIZE study is happening. It aims to see if giving a high dose of vitamin D3 is truly effective and safe for critically ill patients who have very low vitamin D levels. If this study can confirm the earlier findings, it could mean a simple, affordable treatment could be used worldwide to help some of the sickest patients.

Key takeaways

This study investigates if high-dose vitamin D improves survival for severely ill patients.
It focuses on patients in intensive care with very low vitamin D levels.
Patients will receive either high-dose vitamin D or a dummy treatment (placebo).
Results from a previous study hinted at reduced deaths in severely deficient patients.
The study aims to confirm if this potential benefit is real and safe.
If successful, it could lead to a widely available and affordable treatment.

Who may be eligible?

This study is looking for adults aged 18 and over who have been admitted to the intensive care unit (ICU) and are expected to stay for at least two days. A key requirement is that you must have very low levels of vitamin D in your blood – doctors call this 'severe vitamin D deficiency'. You also need to have been admitted to the ICU within the last 72 hours.

There are also some reasons why you wouldn't be able to join the study. These include if you have severe stomach or gut problems that stop you from taking medicines by mouth, if you have very high calcium levels, or if you've recently had kidney stones, tuberculosis, or sarcoidosis. If you are pregnant or breastfeeding, or if your doctor thinks the study isn't suitable for you, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care?
Are you expected to stay in intensive care for at least two days?
Do you have very low vitamin D levels in your blood?
Have you been admitted to intensive care within the last 3 days?
Can you take medicine by mouth or through a feeding tube without problems?

Answer every question to see your result.

What does participation involve?

If you join the VITDALIZE study, you would be randomly assigned to one of two groups: either you'd receive a high dose of vitamin D3, or you'd receive a dummy treatment (placebo) that looks exactly the same but contains no active medicine. Neither you nor your doctors would know which treatment you are getting.

The vitamin D or placebo would be given as a liquid. You'd receive a large starting dose, followed by smaller daily doses for up to 90 days, or until you leave the hospital or the study ends for you. Doctors and nurses would carry out regular checks and assessments as part of your usual care in the ICU, and the study team would collect information about your health and recovery for a period of 28 days after starting the treatment.

Potential risks and benefits

Participating in research always has potential benefits and risks. The potential benefit of this study is that it might improve your chances of survival if you are critically ill and severely vitamin D deficient. However, there's no guarantee it will help everyone, and it's also possible that the vitamin D might not make a difference or could have side effects, though high-dose vitamin D has been used safely in other settings. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

LKH Enzenbach
Verified postcode
Enzenbach, Austria· Recruiting
LKH Feldbach
Verified postcode
Feldbach, Austria· Terminated
Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
Klinikum am Wörthersee
Verified postcode
Klagenfurt, Austria· Recruiting
LKH Hochsteiermark Standort Leoben
Verified postcode
Leoben, Austria· Recruiting
Barmherzige Schwestern
Verified postcode
Linz, Austria· Recruiting
Kepler Universitätsklinikum Linz
Verified postcode
Linz, Austria· Recruiting
Krankenhaus Schwarzach
Verified postcode
Schwarzach im Pongau, Austria· Terminated
Barmherzige Brüder
Verified postcode
Vienna, Austria· Recruiting
Kaiser Franz Josef Spital Wien
Verified postcode
Vienna, Austria· Suspended
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
LKH Villach
Verified postcode
Villach, Austria· Recruiting

Common questions

What is 'critical illness'?

Critical illness means you're very sick and need intensive care in hospital, often with life support to help your body recover.

What is vitamin D3 (cholecalciferol)?

Vitamin D3 is a form of vitamin D, which your body usually makes when exposed to sunlight, and it's important for many body functions, including your immune system.

What does 'placebo-controlled' mean?

This means some patients get the active treatment, and others get a dummy treatment (placebo). This helps researchers see if the real treatment works better than nothing.

Will I know if I'm getting the vitamin D or the dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is over.

Why is 'severe vitamin D deficiency' important for this study?

Previous research suggested that only patients with very low vitamin D levels might benefit, so this study focuses on that specific group to confirm the findings.

How to find out more

Karin Amrein, MD, MSc

karin.amrein@medunigraz.at +43 681 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.