Clinical trial • Phase III • Endocrinology

COLECALCIFEROL for Severe vitamin D deficiency | Critical illness

Phase III trial of COLECALCIFEROL for Severe vitamin D deficiency | Critical illness.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Severe vitamin D deficiency | Critical illness
Trial Stage
Phase III
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
18-10-2024
First CTIS Authorization Date
11-12-2024

Trial design

Randomised, placebo (miglyol 812 n) versus active treatment oleovit d3 tropfen (colecalciferol); dose and schedule not specified in provided data-controlled Phase III trial across 24 sites in Austria, Germany.

Randomised
Yes
Comparator
Placebo (MIGLYOL 812 N) versus active treatment Oleovit D3 Tropfen (colecalciferol); dose and schedule not specified in provided data
Target Sample Size
800
Trial Duration For Participant
365

Eligibility

Recruits 800 Vulnerable population selected: critically ill adult patients. Consent/assent handling materials include documents titled for consent-capable patients ('consentfahig'), for patients not capable of consent ('nicht consentfahig'), for adult representatives ('Erwachsenenvertreter'), and for patients after regaining capacity ('Patient-nach-Wiedererlangung'), indicating that if patients lack capacity consent is sought from an adult representative/proxy and the patient is informed/consented after regaining capacity..

Pregnancy Exclusion
Pregnant/nursing
Vulnerable Population
Vulnerable population selected: critically ill adult patients. Consent/assent handling materials include documents titled for consent-capable patients ('consentfahig'), for patients not capable of consent ('nicht consentfahig'), for adult representatives ('Erwachsenenvertreter'), and for patients after regaining capacity ('Patient-nach-Wiedererlangung'), indicating that if patients lack capacity consent is sought from an adult representative/proxy and the patient is informed/consented after regaining capacity.

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years\n- Expected primary ICU stay ≥ 48 hours\n- ≤ 72 hours in primary ICU at screening blood sample\n- Severe vitamin D deficiency (≤12 ng/ml or undetectable)"}

Exclusion criteria

  • {"criterion_text":"- Hypercalcemia at inclusion (total Ca > 2.65 mmol/l, ionized Ca > 1.35 mmol/l)\n- Study medication intake not possible (mask, ileus, residual volume high)\n- History of kidney stones (≤ 1 year)\n- Granulomatous disease (active tuberculosis or sarcoidosis)\n- Pregnant/nursing\n- Other reasons* (DNR= do not resuscitate, relevant psychiatric disease, prisoner)\n- Hypersensitivity to drug or excipient"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 28-day mortality","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 90-day mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 1-year mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- ICU and hospital mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hospital and ICU length of stay","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Katz Activities of Daily Life (ADL) at day 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Self - reported infections requiring antibiotics until day 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hospital and ICU readmission until day 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hypercalcemia on day 5 (48 hours tolerance)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Self-reported falls, fractures until day 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- New episodes of kidney stones","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
800
Recruitment Window Months
117
Consent Approach
Informed consent: subject information and ICFs are provided for consent-capable patients ('consentfahig') and for patients not capable of consent ('nicht consentfahig'); ICFs for 'Erwachsenenvertreter' (adult representative/proxy) are available. A 'Patient-nach-Wiedererlangung' document is listed (patient informed/consented after regaining capacity). ICF documents are available in German (titles 'SIS und ICF') and there are also English ICF documents for the Germany part ('L1_SIS and ICF_Patient_public'), indicating German and English language materials.

Geography

Total Number Of Sites
24
Total Number Of Participants
1600

Austria

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
11-03-2025
Processing Time Days
127
Number Of Sites
14
Number Of Participants
800

Sites

Site Name
Krankenhaus Der Barmherzigen Brueder St. Veit/Glan
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Michael Zink
Contact Person Email
michael.zink@bbstveit.at
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Rudolf Likar
Contact Person Email
Rudolf.Likar@kabeg.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Jens Meier
Site Name
Krankenhaus Der Barmherzigen Brueder
Department Name
Department of Internal Medicine
Contact Person Name
Gerhard Reicht
Contact Person Email
gerhard.reicht@bbgraz.at
Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Natalija Cokic
Contact Person Email
natalija.cokic@kages.at
Site Name
Medical University Of Vienna
Department Name
Department of Surgery
Contact Person Name
Jakob Mühlbacher
Site Name
Klinik Favoriten
Department Name
Department of Internal Medicine
Contact Person Name
Sabine Schmaldienst
Contact Person Email
sabine.schmaldienst@wienkav.at
Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine Medical University of Vienna
Contact Person Name
Peter Schellongowski
Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Department of Internal Medicine
Contact Person Name
Viktor Wutzl
Contact Person Email
viktor.wutzl@kages.at
Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine Medical University of Graz
Contact Person Name
Philipp Eller
Contact Person Email
philipp.eller@medunigraz.at
Site Name
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
Department Name
Department of Internal Medicine
Contact Person Name
Johann Reisinger
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Department of Internal Medicine
Contact Person Name
Chtrstoph Widhalm
Contact Person Email
christoph.widhalm@kabeg.at
Site Name
Medical University Of Graz
Department Name
Department of Anesthesiology and Intensive Care Medicine Medical University Graz
Contact Person Name
Paul Zajic
Contact Person Email
paul.zajic@medunigraz.at
Site Name
Steiermaerkische Krankenanstalten Ges.m.b.H.
Department Name
Department of Internal Medicine and Pneumology
Contact Person Name
Otmar Schindler
Contact Person Email
otmar.schindler@kages.at

Germany

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
16-06-2025
Processing Time Days
224
Number Of Sites
10
Number Of Participants
800

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Kristina Fuest
Contact Person Email
kristina.fuest@tum.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Anästhesiologie und Operative Intensivmedizin
Contact Person Name
Matthias Lindner
Contact Person Email
Nina.Schulz-Ruhtenberg@uksh.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Contact Person Name
Patrick Meybohm
Contact Person Email
AN_Direktion@ukw.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Christian Putensen
Contact Person Email
intensivmedizin@ukbonn.de
Site Name
Rostock University Medical Center
Department Name
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Contact Person Name
Jens-Christian Schewe
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Neurochirurgische Klinik und Poliklinik
Contact Person Name
Thomas Kerz
Contact Person Email
kerz@uni-mainz.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Anästhesiologie und operative Intensivmedizin
Contact Person Name
Phillip Simon
Site Name
Goethe University Frankfurt
Department Name
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Contact Person Name
Kai Zacharowski
Site Name
Klinikum Oldenburg AöR
Department Name
Universitätsklinik für Anästhesiologie/ Intensivmedizin/Notfallmedizin/Schmerztherapie
Contact Person Name
Simon T. Schäfer
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Anästhesiologie und Intensivmedizin
Contact Person Name
Thorsten Brenner
Contact Person Email
Jens.Brands@uk-essen.de

Sponsor

Primary sponsor

Full Name
Medical University Of Graz
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Oleovit D3 Tropfen
Active Substance
COLECALCIFEROL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (marketing authorisation PRD2057885; marketingAuthNumber 10989 in AT)
Maximum Dose
540000 IU (max daily); 900000 IU (max total)
Investigational Product Name
MIGLYOL 812 N
Modality
Other
Authorisation Status
Not authorised / Not applicable (no marketing authorisation indicated)

Related trials

Other published trials that may interest you.