AuthorisedPhase III and phase IV (Integrated)Interventional

Vitamin D as add-on treatment option of pneumonia and sepsis in elderly subjects (TreatViD)

This research, called "TreatViD," is studying if giving a high dose of vitamin D alongside standard hospital care can improve the health of older patients suffering from serious infections, specifically pneumonia and sepsis. The main goal is to find out if vitamin D helps patients avoid serious problems like needing intensive care or potentially dying within the first 10 days of hospital admission. They also want to see if it helps patients get better faster, leading to discharge or a significant improvement in their symptoms within the same timeframe. The study will also look at how vitamin D affects markers of inflammation in the blood. Patients will either receive the vitamin D treatment or a dummy treatment (placebo).

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Enrolment target

552

Start

10 Sep 2025

Sepsis Pneumonia due to a presumed infection

What is this study about?

This study, named "TreatViD," is looking into how vitamin D might help older people who are very unwell in hospital with serious infections. These infections include pneumonia, which affects the lungs, and sepsis, which is a life-threatening reaction to an infection anywhere in the body. When someone gets sepsis or severe pneumonia, their body can become overwhelmed.

The researchers want to see if giving a high dose of vitamin D, in addition to the treatments they would normally receive in hospital, can make a positive difference. They are particularly interested in whether vitamin D can help patients avoid serious problems like being admitted to intensive care (ICU) or sadly, dying within the first 10 days of coming into hospital. They also want to know if vitamin D helps people recover more quickly, leading to them being well enough to go home or showing big improvements in their symptoms within that same 10-day period.

To do this, patients will be split into two groups. One group will receive the high-dose vitamin D, and the other will receive a dummy treatment called a placebo, which looks identical but contains no active medicine. This allows the researchers to fairly compare the effects of the vitamin D. They will also be measuring certain chemicals in the blood that show how much inflammation is in the body, to see if vitamin D reduces these. All of this information will help them understand if vitamin D could be a useful extra treatment for these serious conditions.

Key takeaways

This study investigates high-dose vitamin D for older patients with severe infections.
It aims to see if vitamin D improves recovery and prevents serious complications.
Participants will receive either vitamin D or a dummy treatment (placebo).
Close monitoring of health and blood tests will be part of the study.
Participation lasts about 10 days from starting treatment, alongside normal hospital care.

Who may be eligible?

This study is particularly looking for older patients who are currently in hospital because they have developed a serious infection like pneumonia or sepsis. To be considered, you would need to be admitted to the hospital with one of these conditions, and your doctors would need to confirm that you fit other specific health criteria for the study.

There isn't an upper age limit, meaning patients of many different ages can be included, provided they meet the other requirements. Both men and women can take part in this research.

Importantly, your doctor or the study team will be able to check your full medical history and current health status against all the study's rules to see if this trial is right for you. They will ensure it's safe and appropriate for your individual situation.

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 currently in hospital with a serious infection like pneumonia or sepsis?
Are you of an older age (the study includes a wide age range)?
Are you able to take medicines by mouth?
Are your doctors happy for you to consider taking part?
Do you or your legal representative understand what the study involves and agree to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either a high dose of vitamin D or a dummy treatment (placebo) by mouth, alongside the standard care you are already getting in hospital. This would be given for a specific period after your hospital admission. You would not know whether you are receiving the vitamin D or the placebo, and neither would your doctors initially – this is called a 'blinded' study and helps ensure fair results.

The research team would regularly monitor your health. This would involve keeping a close eye on your symptoms, how well you are recovering, and possibly taking extra blood samples to check your vitamin D levels and levels of inflammation. These blood tests might happen at days 2, 5, 7, and 10 after you start the study treatment. Your need for oxygen or breathing support would also be tracked, especially if you have pneumonia. The total time you would be actively involved in the study's specific assessments is around 10 days from when you start the treatment, though your hospital stay and recovery would, of course, continue as needed.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new treatment that might help your condition, which isn't currently standard care. You would also have very close monitoring of your health. However, there's no guarantee that the vitamin D will help you, as it's still being tested. There could be potential risks or side effects from the vitamin D, although high-dose vitamin D is generally considered safe under medical supervision for short periods. If you are in the placebo group, you would not receive the new vitamin D treatment. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Italy

Common questions

What is sepsis?

Sepsis is a very serious and life-threatening reaction to an infection. It happens when your body's immune system overreacts to an infection, causing widespread inflammation and organ damage.

What is pneumonia?

Pneumonia is an infection that inflames the air sacs in one or both lungs. The air sacs may fill with fluid or pus, causing cough with phlegm or pus, fever, chills, and difficulty breathing.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare the effects of the active treatment fairly.

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

No, during the study, neither you nor your doctors will know whether you are receiving the vitamin D or the placebo. This helps ensure the study results are fair and unbiased.

Can I still receive my regular hospital care?

Absolutely. The vitamin D or placebo would be given in addition to the standard medical care you would normally receive for your pneumonia or sepsis in the hospital. Your regular care continues as usual.