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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Krankenhaus Der Barmherzigen Brueder St. Veit/Glan St. Veit An Der Glan Austria
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Kepler Universitaetsklinikum GmbH Linz Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinik Favoriten Vienna Austria
Uzhlcdossunqnemyyuhrx Esqyz Ahs Essen Germany
Udxqvfwvjkviujokkrpfi Afmaftpv Augsburg Germany
Krruwardtcp Dev Bkqcdiodbwwh Bzfxzum Graz Austria
Sjhnjsvlisfptfon Kdcurzvizdmrvicr Gvzlmkaixg Graz Austria
Stznpeccgktncxfu Kjorqkyixjjbiwvj Gphofbtrzc Leoben Austria
Gtzusz Uxfzfgidws Ftpegkycy Frankfurt Germany
Urucjztfzneslutybkfel Wcogoivtr Aeh Wuerzburg Germany
Kstmuwh Dpk Buqhhvyouiro Bicyyps Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.03.2017
Germany Germany
Recruiting
01.03.2017

Trial locations

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.

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 ID:
2024-514556-32-00
Protocol code:
The VitDalize Study
Trial Phase:
Therapeutic confirmatory (Phase III)

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