Critical IllnessPhase 3VITDALIZENCT03188796
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
A Phase 3 study testing Cholecalciferol in people with Critical Illness and Vitamin D Deficiency, run by Medical University of Graz at 18 sites in 4 countries.
Trial summary
In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critical Illness, Vitamin D Deficiency, Covid19
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,400 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 10 Oct 2017to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Anticipated ICU stay ≥ 48 hours
- Admission to ICU ≤ 72 hours before screening
- Severe vitamin D deficiency (≤12 ng/ml or undetectable)
Who cannot join
- Severe gastrointestinal dysfunction (> 400 ml residual volume)/unable to take study medication
- Do not resuscitate (DNR) order/imminent death
- hypercalcemia
- known recent nephrolithiasis, active tuberculosis or sarcoidosis
- pregnancy/lactation
- not deemed appropriate by study team/physician
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Austria12 sites
LKH Enzenbach
Enzenbach
LKH Feldbach
Feldbach
Medical University of Graz
Graz
Klinikum am Wörthersee
Klagenfurt
LKH Hochsteiermark Standort Leoben
Leoben
Barmherzige Schwestern
Linz
Kepler Universitätsklinikum Linz
Linz
Krankenhaus Schwarzach
Schwarzach im Pongau
Barmherzige Brüder
Vienna
Kaiser Franz Josef Spital Wien
Vienna
Medical University of Vienna
Vienna
LKH Villach
Villach
Belgium4 sites
Erasme Hospital
Brussels
CHU de Charleroi
Charleroi
CHR Citadelle
Liège
CHU Ambroise Pare
Mons
About this study
Official title: The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT)
In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies.
To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.
Read the detailed description
A very limited number of intervention trials, most including less than 30 patients, have been published. The only phase III study, our VITdAL-ICU study recruited from 2010 to 2012 and (n=475) did not find a difference in the primary endpoint "length of hospital stay" between placebo and high-dose vitamin D3. However, there was a non-significant absolute risk reduction in all-cause hospital mortality in the total population. The difference was larger (17.5%) and significant in the predefined subgroup of patients with severe vitamin D deficiency at baseline, see Kaplan Meier curve below (n=200, 28.6 vs 46.1%, p=0.01, 0.56 (0.35-0.90) ), corresponding to a number needed to treat of 6. (51) As this was only a secondary endpoint in the predefined subgroup with severe vitamin D deficiency, this finding is hypothesis generating and requires further study, leading to this application.
In our study, we were unable to identify a mechanism by which this benefit was achieved. Interestingly, looking at the causes of death, the vitamin D group seemed to benefit in every category.
The VITDALIZE study is a pragmatic, multicenter, placebo-controlled double-blind randomized controlled phase III trial in adult critically ill patients which will be conducted in academic and non-academic centers. The sponsor is the Medical University of Graz, Austria.
Subjects will be randomised in a 1:1 ratio to receive either of the two treatments:
Vitamin D: oral/enteral pharmacological dose of cholecalciferol (vitamin D3)
- total dose 900,000
- loading dose of 540,0000 (dissolved in 37.5 ml of medium chain triglycerides - MCT) followed by 4000 IU daily (10 drops) for the entire active study period (90 days)
Placebo: identical regime - loading dose of 37.5 ml MCT followed by 10 drops daily
This study uses a group sequential design, with one interim analysis when 50% of the planned enrolled patients in each arm (N=600 per arm) have completed their day 28 assessment by the independent data safety monitoring board. The enrollment of patients will continue while the interim analyses is performed.
- Conditions
- Critical Illness, Vitamin D Deficiency, Covid19
- Being tested
- Cholecalciferol, Placebo
- Keywords
- vitamin D, critical care, COVID-19
- Medical subject headings
- Critical Illness, Vitamin D Deficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days
PlaceboDrug
oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days Receives: Drug: Placebo |
| High Dose Vitamin D3 | Experimental | oral/enteral pharmacological dose of cholecalciferol (vitamin D3) - total dose 900,000
* loading dose of 540,0000 (dissolved in 37.5 ml of medium chain triglycerides - MCT)
* followed by 4000 IU daily (10 drops) for the entire active study period (90 days) Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
all-cause mortality
Measured: 28 days
Secondary outcomes (3)
Hospital Length of stay
Length of stay in days
Measured: 90 days
Hypercalcemia at day 5
Measured: Day 5 - 48 hours tolerance
Hospital readmissions
Number of readmissions
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start10 Oct 2017
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Hospital Barmherzige Brüder St. Veit, Klinikum Klagenfurt am Wörthersee, Johannes Kepler University of Linz, Krankenhaus Barmherzige Schwestern Linz, Barmherzige Brüder Vienna, Erasme University Hospital, The Queen Elizabeth Hospital, Goethe University, Kages, KABEG Management, Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Universitaire de Charleroi, Centre Hospitalier Universitaire Mons, Wuerzburg University Hospital, Royal Bolton Hospital NHS Foundation Trust, Heartlands Hospital, Royal Oldham Hospital, East Lancashire Hospitals NHS Trust, University of Plymouth, Royal Victoria Hospital, Belfast, Great Western Hospital, Mid Yorkshire Teaching NHS Trust, Musgrove Park Hospital, Scunthorpe General Hospital, Guy's and St Thomas' NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hospital Barmherzige Brüder Graz, University Hospital Schleswig-Holstein, University Hospital, Bonn, Johannes Gutenberg University Mainz, University Hospital, Essen, Klinikum rechts der Isar der TUM, Landeskrankenhaus Villach
- Responsible party
- Sponsor
- Investigators
- Karin Amrein, MD, MSc, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188796
- Sponsor's protocol ID
- VITDALIZE 1.0
- Acronym
- VITDALIZE
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2017
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
PubMed 25268295Amrein K, Christopher KB, McNally JD. Understanding vitamin D deficiency in intensive care patients. Intensive Care Med. 2015 Nov;41(11):1961-4. doi: 10.1007/s00134-015-3937-4. Epub 2015 Jul 4. No abstract available.
PubMed 26142054Amrein K. Vitamin D status in critical care: Contributor or marker of poor health? Lung India. 2014 Jul;31(3):299-300. No abstract available.
PubMed 25125826Amrein K, Papinutti A, Mathew E, Vila G, Parekh D. Vitamin D and critical illness: what endocrinology can learn from intensive care and vice versa. Endocr Connect. 2018 Dec 1;7(12):R304-R315. doi: 10.1530/EC-18-0184.
PubMed 30352414National Heart, Lung, and Blood Institute PETAL Clinical Trials Network; Ginde AA, Brower RG, Caterino JM, Finck L, Banner-Goodspeed VM, Grissom CK, Hayden D, Hough CL, Hyzy RC, Khan A, Levitt JE, Park PK, Ringwood N, Rivers EP, Self WH, Shapiro NI, Thompson BT, Yealy DM, Talmor D. Early High-Dose Vitamin D3 for Critically Ill, Vitamin D-Deficient Patients. N Engl J Med. 2019 Dec 26;381(26):2529-2540. doi: 10.1056/NEJMoa1911124. Epub 2019 Dec 11.
PubMed 31826336Kobayashi H, Amrein K, Mahmoud SH, Lasky-Su JA, Christopher KB. Metabolic phenotypes and vitamin D response in the critically ill: A metabolomic cohort study. Clin Nutr. 2024 Nov;43(11):10-19. doi: 10.1016/j.clnu.2024.09.030. Epub 2024 Sep 18.
PubMed 39307095Geiger C, McNally JD, Christopher KB, Amrein K. Vitamin D in the critically ill - update 2024. Curr Opin Clin Nutr Metab Care. 2024 Nov 1;27(6):515-522. doi: 10.1097/MCO.0000000000001068. Epub 2024 Aug 26.
PubMed 39302310Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
PubMed 33757717Amrein K, Parekh D, Westphal S, Preiser JC, Berghold A, Riedl R, Eller P, Schellongowski P, Thickett D, Meybohm P; VITDALIZE Collaboration Group. Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study). BMJ Open. 2019 Nov 12;9(11):e031083. doi: 10.1136/bmjopen-2019-031083.
PubMed 31722941
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT03188796
- Acronym / sponsor ID
- VITDALIZE / VITDALIZE 1.0
- Conditions
- Critical Illness, Vitamin D Deficiency, Covid19
- Keywords
- vitamin D, critical care, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Hospital Barmherzige Brüder St. Veit, Klinikum Klagenfurt am Wörthersee, Johannes Kepler University of Linz, Krankenhaus Barmherzige Schwestern Linz, Barmherzige Brüder Vienna, Erasme University Hospital, The Queen Elizabeth Hospital, Goethe University, Kages, KABEG Management, Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Universitaire de Charleroi, Centre Hospitalier Universitaire Mons, Wuerzburg University Hospital, Royal Bolton Hospital NHS Foundation Trust, Heartlands Hospital, Royal Oldham Hospital, East Lancashire Hospitals NHS Trust, University of Plymouth, Royal Victoria Hospital, Belfast, Great Western Hospital, Mid Yorkshire Teaching NHS Trust, Musgrove Park Hospital, Scunthorpe General Hospital, Guy's and St Thomas' NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hospital Barmherzige Brüder Graz, University Hospital Schleswig-Holstein, University Hospital, Bonn, Johannes Gutenberg University Mainz, University Hospital, Essen, Klinikum rechts der Isar der TUM, Landeskrankenhaus Villach
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies.
To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.
Detailed description
A very limited number of intervention trials, most including less than 30 patients, have been published. The only phase III study, our VITdAL-ICU study recruited from 2010 to 2012 and (n=475) did not find a difference in the primary endpoint "length of hospital stay" between placebo and high-dose vitamin D3. However, there was a non-significant absolute risk reduction in all-cause hospital mortality in the total population. The difference was larger (17.5%) and significant in the predefined subgroup of patients with severe vitamin D deficiency at baseline, see Kaplan Meier curve below (n=200, 28.6 vs 46.1%, p=0.01, 0.56 (0.35-0.90) ), corresponding to a number needed to treat of 6. (51) As this was only a secondary endpoint in the predefined subgroup with severe vitamin D deficiency, this finding is hypothesis generating and requires further study, leading to this application.
In our study, we were unable to identify a mechanism by which this benefit was achieved. Interestingly, looking at the causes of death, the vitamin D group seemed to benefit in every category.
The VITDALIZE study is a pragmatic, multicenter, placebo-controlled double-blind randomized controlled phase III trial in adult critically ill patients which will be conducted in academic and non-academic centers. The sponsor is the Medical University of Graz, Austria.
Subjects will be randomised in a 1:1 ratio to receive either of the two treatments:
Vitamin D: oral/enteral pharmacological dose of cholecalciferol (vitamin D3)
- total dose 900,000
- loading dose of 540,0000 (dissolved in 37.5 ml of medium chain triglycerides - MCT) followed by 4000 IU daily (10 drops) for the entire active study period (90 days)
Placebo: identical regime - loading dose of 37.5 ml MCT followed by 10 drops daily
This study uses a group sequential design, with one interim analysis when 50% of the planned enrolled patients in each arm (N=600 per arm) have completed their day 28 assessment by the independent data safety monitoring board. The enrollment of patients will continue while the interim analyses is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebooral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days |
| High Dose Vitamin D3 | Experimental | Drug: Cholecalciferoloral/enteral pharmacological dose of cholecalciferol (vitamin D3) - total dose 900,000 * loading dose of 540,0000 (dissolved in 37.5 ml of medium chain triglycerides - MCT) * followed by 4000 IU daily (10 drops) for the entire active study period (90 days) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- Anticipated ICU stay ≥ 48 hours
- Admission to ICU ≤ 72 hours before screening
- Severe vitamin D deficiency (≤12 ng/ml or undetectable)
Key exclusion criteria (6 listed)
- Severe gastrointestinal dysfunction (> 400 ml residual volume)/unable to take study medication
- Do not resuscitate (DNR) order/imminent death
- hypercalcemia
- known recent nephrolithiasis, active tuberculosis or sarcoidosis
- pregnancy/lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Vitamin D3oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days | Drug | High Dose Vitamin D3 |
| Placebooral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days | Drug | Placebo |
Primary outcome
28-day mortality
Time frame: 28 days
all-cause mortality
3 secondary outcomes
Hospital Length of stay
Time frame: 90 days
Hypercalcemia at day 5
Time frame: Day 5 - 48 hours tolerance
Hospital readmissions
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 25268295Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.
- Background: PubMed 26142054Amrein K, Christopher KB, McNally JD. Understanding vitamin D deficiency in intensive care patients. Intensive Care Med. 2015 Nov;41(11):1961-4. doi: 10.1007/s00134-015-3937-4. Epub 2015 Jul 4. No abstract available.
- Background: PubMed 25125826Amrein K. Vitamin D status in critical care: Contributor or marker of poor health? Lung India. 2014 Jul;31(3):299-300. No abstract available.
- Background: PubMed 30352414Amrein K, Papinutti A, Mathew E, Vila G, Parekh D. Vitamin D and critical illness: what endocrinology can learn from intensive care and vice versa. Endocr Connect. 2018 Dec 1;7(12):R304-R315. doi: 10.1530/EC-18-0184.
- Background: PubMed 31826336National Heart, Lung, and Blood Institute PETAL Clinical Trials Network; Ginde AA, Brower RG, Caterino JM, Finck L, Banner-Goodspeed VM, Grissom CK, Hayden D, Hough CL, Hyzy RC, Khan A, Levitt JE, Park PK, Ringwood N, Rivers EP, Self WH, Shapiro NI, Thompson BT, Yealy DM, Talmor D. Early High-Dose Vitamin D3 for Critically Ill, Vitamin D-Deficient Patients. N Engl J Med. 2019 Dec 26;381(26):2529-2540. doi: 10.1056/NEJMoa1911124. Epub 2019 Dec 11.
- Background: PubMed 39307095Kobayashi H, Amrein K, Mahmoud SH, Lasky-Su JA, Christopher KB. Metabolic phenotypes and vitamin D response in the critically ill: A metabolomic cohort study. Clin Nutr. 2024 Nov;43(11):10-19. doi: 10.1016/j.clnu.2024.09.030. Epub 2024 Sep 18.
- Background: PubMed 39302310Geiger C, McNally JD, Christopher KB, Amrein K. Vitamin D in the critically ill - update 2024. Curr Opin Clin Nutr Metab Care. 2024 Nov 1;27(6):515-522. doi: 10.1097/MCO.0000000000001068. Epub 2024 Aug 26.
- Derived from this study: PubMed 33757717Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
- Derived from this study: PubMed 31722941Amrein K, Parekh D, Westphal S, Preiser JC, Berghold A, Riedl R, Eller P, Schellongowski P, Thickett D, Meybohm P; VITDALIZE Collaboration Group. Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study). BMJ Open. 2019 Nov 12;9(11):e031083. doi: 10.1136/bmjopen-2019-031083.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Amrein, MD, MSc principal investigator
Medical University of Graz
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol in people with Critical Illness and Vitamin D Deficiency, run by Medical University of Graz at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Austria, Belgium, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188796, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.