Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

High-Dose Colecalciferol for 28-Day Mortality in Critically Ill Adults with Severe Vitamin D Deficiency

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is studying adult critically ill patients with severe vitamin D deficiency, a condition in which the body has very low levels of vitamin D and the person is seriously unwell. The study is testing colecalciferol, a form of vitamin D3, given as oral drops, and comparing it with placebo. The purpose of the study is to find out whether a high dose of vitamin D3 can improve recovery and reduce the chance of death in the first 28 days after treatment.

In this study, people receive either the vitamin D3 drops or placebo, and the care team follows their progress over time. The study looks at what happens during the hospital stay and after discharge, including survival, time in intensive care, time in the hospital, and later health problems such as infections, falls, fractures, and kidney stones. It also checks for possible side effects of high vitamin D, such as hypercalcemia, which means too much calcium in the blood.

The research process

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

  1. Step 1

    Start of study participation

    After joining the study, you are assigned to receive one of two study products in a double-blind trial, which means that neither you nor the study team knows which product you receive during the study.

    The study product is given by mouth as oral drops.

    The possible study products are colecalciferol (vitamin d3) or placebo. A placebo is a look-alike product that does not contain the active medicine.

    If you receive the active study product, the dose is 540,000 iu as a single administration by mouth. iu means international units.

    If you receive the placebo, the product is miglyol 812 n and is given in the same way as the active product.

  2. Step 2

    First 28 days after study treatment

    Your outcome is followed during the first 28 days after study treatment.

    The main result measured in this period is 28-day mortality, which means whether death occurs within 28 days.

    During this period, your stay in the intensive care unit or in the hospital is also tracked. the intensive care unit, often called icu, is the part of the hospital for patients who need very close monitoring and treatment.

    The study also tracks whether you have any organ failures. an organ is a body part such as the heart, lungs, kidneys, or liver that has an important function.

  3. Step 3

    Day 5 assessment

    Around day 5 after treatment, with a tolerance of 48 hours before or after that day, your condition is checked using the sofa score.

    The sofa score is a way to measure how well several body organs are working.

    At this time, the study also checks the number of organ failures, using a definition based on more than 2 points in each of the 6 categories of the sofa score.

    The study checks for hypercalcemia, which means too much calcium in the blood.

  4. Step 4

    Follow-up until day 90

    Follow-up continues until day 90 after study treatment.

    The study checks 90-day mortality, which means whether death occurs within 90 days.

    The study checks whether you are readmitted to the hospital or icu during this time.

    The study checks whether you report any infections requiring antibiotics. antibiotics are medicines used to treat infections.

    The study checks whether you report any falls or fractures. a fracture means a broken bone.

    The study checks for any new episodes of kidney stones. kidney stones are hard pieces of material that can form in the kidneys.

    The study also assesses katz activities of daily life at day 90. this is a measure of how well you can do everyday tasks such as bathing, dressing, and eating.

  5. Step 5

    Longer-term follow-up up to 1 year

    Your outcome is also followed for up to 1 year after study treatment.

    The study measures 1-year mortality, which means whether death occurs within 1 year.

Who can join the trial?

5 criteria

  • Be an adult, meaning 18 years of age or older.
  • Be critically ill and receiving care in the intensive care unit (ICU), which is a hospital area for patients who need very close monitoring and treatment.
  • Be expected to stay in the primary ICU for at least 48 hours.
  • Have had the blood sample for screening taken within 72 hours of being in the primary ICU.
  • Have severe vitamin D deficiency, meaning a blood vitamin D level of 12 ng/ml or less, or vitamin D that is undetectable in the blood test.

Who cannot join the trial?

9 criteria

  • Having too much calcium in the blood at the time of study entry, called hypercalcemia. This means total calcium above 2.65 mmol/L or ionized calcium above 1.35 mmol/L.
  • Being unable to take the study medicine by the mouth or through the feeding route, for example because of a mask used for breathing, ileus (a bowel blockage or very slow bowel movement), or a very high residual volume (too much liquid left in the stomach after feeding).
  • Having had kidney stones within the past 1 year.
  • Having a granulomatous disease, such as active tuberculosis or sarcoidosis. These are conditions that cause clusters of inflammatory cells to form in the body.
  • Being pregnant or nursing a baby.
  • Having a do not resuscitate order, meaning a decision not to use emergency life-saving measures if the heart or breathing stops.
  • Having a relevant psychiatric disease, meaning a mental health condition that may affect safe study participation.
  • Being a prisoner.
  • Having a hypersensitivity or allergy to the study drug or any of its ingredients, called an excipient.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Vitamin D3 (colecalciferol) is the active treatment in this study. It is given by mouth as liquid drops and is used to quickly raise very low vitamin D levels in very sick adult patients. The goal is to see whether correcting severe vitamin D deficiency can help improve recovery and reduce the chance of death within 28 days.

What is already known about the treatment

  • Colecalciferol

    Colecalciferol is given by mouth as oral drops, and in this trial it was used as a high-dose liquid solution. It is a form of vitamin D3 that is well known in medical practice and medical literature, mainly used to treat or prevent vitamin D deficiency and related bone problems such as rickets and osteoporosis. It works by being changed in the body into the active form of vitamin D, which helps the intestines absorb calcium and phosphate and also supports normal immune and muscle function. It belongs to the pharmacological group of vitamin D and other vitamin D analogs, and its official code is A11CC05.

  • Miglyol 812 N

    Miglyol 812 N is given by mouth as an inactive liquid used to match the study treatment in appearance and taste, but it has no known active medicine in this trial. It is not a therapeutic drug in medical practice and is mainly used as a carrier or placebo ingredient in clinical research. Because it has no active substance, it does not have a direct medical indication or a specific mechanism of action for treating disease. It is classified as a placebo or inert excipient rather than a pharmacological treatment.

Investigated diseases

Severe vitamin D deficiency - A condition in which the body has very low vitamin D levels, leading to poor calcium and bone balance and, in some cases, muscle weakness or general tiredness. It often develops slowly and may not cause clear symptoms at first. If it continues, it can affect bone health and contribute to weakened muscles and a higher risk of falls. In very ill adults, it may also be part of a broader state of poor nutrition and body stress.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514556-32-00Protocol codeThe VitDalize StudyEstimated enrolment2 200 patientsSponsorMedical University Of Graz

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.