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Study of vitamin D3 (cholecalciferol) as additional treatment for elderly patients with pneumonia or sepsis due to infection

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the effects of high-dose vitamin D3 (cholecalciferol) in elderly patients who are hospitalized with either pneumonia or sepsis. Pneumonia is a lung infection that can be seen on chest x-rays, while sepsis is a serious condition where the body has an extreme response to an infection that can be life-threatening.

The study tests whether giving additional vitamin D3 along with standard treatment can help patients leave the hospital sooner or reduce inflammation in the body. Participants will receive either vitamin D3 solution (DIBASE) or placebo in the form of refined olive oil. The treatment will be given by mouth and can last up to 12 months.

The research focuses on measuring how well patients recover during their hospital stay, including how quickly they can be discharged and whether they need intensive care. The study will also track changes in substances in the blood that show inflammation levels, particularly proteins called IL-6 and C-reactive protein. Patients will be monitored for up to 90 days to assess their recovery and any effects of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
Your blood will be tested to check vitamin D levels. You are eligible for the study if your levels are below 20 ng/ml.
The study is for patients aged 65 or older who are hospitalized with pneumonia or sepsis (a serious condition caused by your body's response to an infection).
You must have started experiencing symptoms no more than 10 days ago.
Step 2
Treatment initiation
You will receive either high-dose vitamin D3 (cholecalciferol) or a placebo (inactive substance) as an oral solution.
The medication is called DIBASE and contains 50,000 units of vitamin D in 2.5 ml of solution.
Step 3
Monitoring period - first 10 days
Blood samples will be taken on days 2, 5, 7, and 10 to monitor your vitamin D levels and other health markers.
Your condition will be regularly assessed to check for improvement or need for additional care.
If you have pneumonia, your oxygen needs will be monitored.
Step 4
Extended follow-up
Your health status will be checked at 14, 28, and 90 days after starting the treatment.
These checks will help determine the long-term effects of the treatment.
Step 5
Safety monitoring
Throughout the study, you will be monitored for any side effects or unexpected reactions to the treatment.
Your inflammatory markers and overall health condition will be regularly assessed through blood tests.

Who can join the trial?

8 criteria

Must be 65 years or older (both men and women can participate)
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Must have one of these conditions:
- Pneumonia (lung infection) confirmed by chest X-ray or CT scan, including COVID-19 pneumonia confirmed by testing, or
- Sepsis (a serious condition where the body's response to infection causes injury to its own tissues)
- Must need to stay in a regular hospital ward (not intensive care unit)
- Must have low vitamin D levels (less than 20 ng/ml) when admitted to hospital
- Symptoms must have started no more than 10 days before joining the study
- Must have a NEWS2 score higher than 2 (NEWS2 is a tool doctors use to measure how sick a patient is)
- Must be able to understand and sign the consent form, or have a legal representative who can do this

Who cannot join the trial?

15 criteria

Age below 65 years old
Known hypersensitivity (allergic reaction) to vitamin D3 or any of its components
Current use of medications that interact with vitamin D metabolism
Presence of hypercalcemia (high levels of calcium in blood)
Severe kidney disease or kidney failure
Severe liver disease
Active tuberculosis (TB) infection
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Inability to provide informed consent
History of sarcoidosis (an inflammatory disease affecting multiple organs)
Active cancer treatment
Use of high-dose vitamin D supplements in the past month
Severe mental illness that could affect participation
Life expectancy less than 24 hours

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

Trial locations

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Investigated drugs

Vitamin D3 (cholecalciferol) is a vitamin supplement that helps your body maintain healthy levels of calcium and phosphorus. In this trial, it is being studied as an additional treatment for elderly patients with pneumonia (including COVID-19) or sepsis. Vitamin D3 plays an important role in supporting the immune system and reducing inflammation in the body. The trial aims to see if high doses of vitamin D3 can help patients recover faster and leave the hospital sooner.

Colecalciferol

What is already known about the treatment

Cholecalciferol (Vitamin D3) - A fat-soluble vitamin typically administered orally in tablet or liquid form, which plays a crucial role in immune system function and inflammatory response. This medication is well-established in medical literature and is being investigated as a potential add-on treatment for pneumonia and sepsis, particularly in elderly patients. Cholecalciferol works by binding to vitamin D receptors throughout the body, regulating calcium absorption, supporting immune cell function, and modulating inflammatory responses at the molecular level. It belongs to the class of vitamin D and vitamin D analogues, and current clinical trials are exploring its therapeutic potential in reducing inflammation markers and improving outcomes in severe infections.

Investigated diseases

Sepsis
A serious condition that occurs when the body's response to infection causes widespread inflammation throughout the body. It begins when an infection triggers a chain reaction in the body, leading to changes in temperature, heart rate, and breathing. The condition can develop from any type of infection, including those in the lungs, urinary tract, skin, or other parts of the body. As sepsis progresses, it can affect multiple organ systems and cause changes in blood pressure and oxygen levels.
Pneumonia
An infection that causes inflammation in the air sacs of one or both lungs. The air sacs may fill with fluid or pus, causing symptoms such as cough, fever, chills, and difficulty breathing. The condition can affect people of any age but is more common in older adults and those with weakened immune systems. The infection can be caused by various organisms, including bacteria, viruses, and fungi.