Critical IllnessPhase 3VITdAL@ICUNCT01130181

VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients

A Phase 3 study testing Cholecalciferol in people with Critical Illness and Vitamin D Deficiency, run by Harald Dobnig, MD at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study hypothesis: High-dose vitamin D leads to a shorter hospital stay in critically ill patients Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Vitamin D Deficiency
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: 480 participants
Where: 1 siteAustria
Study dates: May 2010to Sep 2012
Phase: Phase 3
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years
expected ICU stay ≥48 hours
vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Who cannot join

moribund patient expected to die within 24 hours
hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
known history of recent kidney stones (≤ 1 year)
known granulomatous diseases (tuberculosis, sarcoidosis)
pregnancy

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Graz
Graz, 8036

Other trials in Austria

About this study

Official title: Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

Study hypothesis:

High-dose vitamin D leads to a shorter hospital stay in critically ill patients

Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Read the detailed description

Inclusion criteria

Age ≥18 years
expected ICU stay ≥48 hours
vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion criteria

moribund patient expected to die within 24 hours
hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
known history of recent kidney stones (≤ 1 year)
known granulomatous diseases (tuberculosis, sarcoidosis)
pregnancy

Primary endpoint

hospital stay (hours; starting from ICU admission) Secondary endpoints
percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7
serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium

Conditions: Critical Illness, Vitamin D Deficiency
Being tested: Cholecalciferol, Placebo
Medical subject headings: Critical Illness, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CholecalciferolDrug
loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
PlaceboDrug
Also called herbal oil
Matching placebo

Study groups in NCT01130181
Study group	Role	What they receive
Cholecalciferol	Experimental	Not described Receives: Drug: Cholecalciferol
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of hospital stay
The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.
Measured: maximum 6 months

Secondary outcomes (5)

25(OH)D levels
serum 25(OH)D levels will be measured on day 0, 3 and 7
Measured: maximum 6 months
calcium levels
serum calcium levels will be measured on day 0, 3 and 7
Measured: maximum 6 months
length of ICU stay starting from application of study medication
Measured: until patient's death or referral to another ward
duration of mechanical ventilation
duration of mechanical ventilation including CPAP/mask ventilation
Measured: starting from application of study medication
hospital mortality, 28-day mortality, 6 month-mortality
Measured: maximum 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Sep 2012

First posted25 May 2010 (estimated)
Study startMay 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)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: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01130181
Sponsor's protocol ID: VITdAL@ICU - 19022010
Acronym: VITdAL@ICU
Status last verified: May 2014
First submitted: 21 May 2010
Last updated: 28 May 2014
Results posted: No
Data monitoring committee: Yes

Publications

Lee P, Eisman JA, Center JR. Vitamin D deficiency in critically ill patients. N Engl J Med. 2009 Apr 30;360(18):1912-4. doi: 10.1056/NEJMc0809996. No abstract available.
PubMed 19403914
Lucidarme O, Messai E, Mazzoni T, Arcade M, du Cheyron D. Incidence and risk factors of vitamin D deficiency in critically ill patients: results from a prospective observational study. Intensive Care Med. 2010 Sep;36(9):1609-11. doi: 10.1007/s00134-010-1875-8. Epub 2010 Apr 7. No abstract available.
PubMed 20373095
Lee P, Nair P, Eisman JA, Center JR. Vitamin D deficiency in the intensive care unit: an invisible accomplice to morbidity and mortality? Intensive Care Med. 2009 Dec;35(12):2028-32. doi: 10.1007/s00134-009-1642-x. Epub 2009 Sep 15.
PubMed 19756497
Mata-Granados JM, Vargas-Vasserot J, Ferreiro-Vera C, Luque de Castro MD, Pavon RG, Quesada Gomez JM. Evaluation of vitamin D endocrine system (VDES) status and response to treatment of patients in intensive care units (ICUs) using an on-line SPE-LC-MS/MS method. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):452-5. doi: 10.1016/j.jsbmb.2010.03.078. Epub 2010 Apr 21.
PubMed 20399267
Krishnan A, Ochola J, Mundy J, Jones M, Kruger P, Duncan E, Venkatesh B. Acute fluid shifts influence the assessment of serum vitamin D status in critically ill patients. Crit Care. 2010;14(6):R216. doi: 10.1186/cc9341. Epub 2010 Nov 26.
PubMed 21110839
Amrein K, Venkatesh B. Vitamin D and the critically ill patient. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):188-93. doi: 10.1097/MCO.0b013e32834f0027.
PubMed 22186356
Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.
PubMed 21926604
Amrein K, Schnedl C, Berghold A, Pieber TR, Dobnig H. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial. BMC Endocr Disord. 2012 Nov 7;12:27. doi: 10.1186/1472-6823-12-27.
PubMed 23134762
Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wunsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.
PubMed 24661739
Schwetz V, Schnedl C, Urbanic-Purkart T, Trummer C, Dimai HP, Fahrleitner-Pammer A, Putz-Bankuti C, Christopher KB, Obermayer-Pietsch B, Pieber TR, Dobnig H, Amrein K. Effect of vitamin D3 on bone turnover markers in critical illness: post hoc analysis from the VITdAL-ICU study. Osteoporos Int. 2017 Dec;28(12):3347-3354. doi: 10.1007/s00198-017-4190-1. Epub 2017 Aug 25.
PubMed 28842727
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 25268295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")
ClinicalTrials.gov ID: NCT01130181
Acronym / sponsor ID: VITdAL@ICU / VITdAL@ICU - 19022010
Conditions: Critical Illness, Vitamin D Deficiency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Harald Dobnig, MDUniversity, hospital or other
Study start: May 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 25 May 2010 (estimated)
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.

Study hypothesis:

High-dose vitamin D leads to a shorter hospital stay in critically ill patients

Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Detailed description

Inclusion criteria

Age ≥18 years
expected ICU stay ≥48 hours
vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion criteria

moribund patient expected to die within 24 hours
hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
known history of recent kidney stones (≤ 1 year)
known granulomatous diseases (tuberculosis, sarcoidosis)
pregnancy

Primary endpoint

hospital stay (hours; starting from ICU admission) Secondary endpoints
percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7
serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium

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
Cholecalciferol	Experimental	Drug: Cholecalciferol
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18 years
expected ICU stay ≥48 hours
vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Key exclusion criteria (6 listed)

moribund patient expected to die within 24 hours
hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
known history of recent kidney stones (≤ 1 year)
known granulomatous diseases (tuberculosis, sarcoidosis)

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
Cholecalciferolloading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU	Drug	Cholecalciferol
PlaceboAlso: herbal oilMatching placebo	Drug	Placebo

Primary outcome

Length of hospital stay
Time frame: maximum 6 months
The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.

5 secondary outcomes

25(OH)D levels
Time frame: maximum 6 months
calcium levels
Time frame: maximum 6 months
length of ICU stay starting from application of study medication
Time frame: until patient's death or referral to another ward
duration of mechanical ventilation
Time frame: starting from application of study medication
hospital mortality, 28-day mortality, 6 month-mortality
Time frame: maximum 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
Background: PubMed 19403914Lee P, Eisman JA, Center JR. Vitamin D deficiency in critically ill patients. N Engl J Med. 2009 Apr 30;360(18):1912-4. doi: 10.1056/NEJMc0809996. No abstract available.
Background: PubMed 20373095Lucidarme O, Messai E, Mazzoni T, Arcade M, du Cheyron D. Incidence and risk factors of vitamin D deficiency in critically ill patients: results from a prospective observational study. Intensive Care Med. 2010 Sep;36(9):1609-11. doi: 10.1007/s00134-010-1875-8. Epub 2010 Apr 7. No abstract available.
Background: PubMed 19756497Lee P, Nair P, Eisman JA, Center JR. Vitamin D deficiency in the intensive care unit: an invisible accomplice to morbidity and mortality? Intensive Care Med. 2009 Dec;35(12):2028-32. doi: 10.1007/s00134-009-1642-x. Epub 2009 Sep 15.
Background: PubMed 20399267Mata-Granados JM, Vargas-Vasserot J, Ferreiro-Vera C, Luque de Castro MD, Pavon RG, Quesada Gomez JM. Evaluation of vitamin D endocrine system (VDES) status and response to treatment of patients in intensive care units (ICUs) using an on-line SPE-LC-MS/MS method. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):452-5. doi: 10.1016/j.jsbmb.2010.03.078. Epub 2010 Apr 21.
Background: PubMed 21110839Krishnan A, Ochola J, Mundy J, Jones M, Kruger P, Duncan E, Venkatesh B. Acute fluid shifts influence the assessment of serum vitamin D status in critically ill patients. Crit Care. 2010;14(6):R216. doi: 10.1186/cc9341. Epub 2010 Nov 26.
Background: PubMed 22186356Amrein K, Venkatesh B. Vitamin D and the critically ill patient. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):188-93. doi: 10.1097/MCO.0b013e32834f0027.
Background: PubMed 21926604Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.
Background: PubMed 23134762Amrein K, Schnedl C, Berghold A, Pieber TR, Dobnig H. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial. BMC Endocr Disord. 2012 Nov 7;12:27. doi: 10.1186/1472-6823-12-27.
Background: PubMed 24661739Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wunsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.
Derived from this study: PubMed 28842727Schwetz V, Schnedl C, Urbanic-Purkart T, Trummer C, Dimai HP, Fahrleitner-Pammer A, Putz-Bankuti C, Christopher KB, Obermayer-Pietsch B, Pieber TR, Dobnig H, Amrein K. Effect of vitamin D3 on bone turnover markers in critical illness: post hoc analysis from the VITdAL-ICU study. Osteoporos Int. 2017 Dec;28(12):3347-3354. doi: 10.1007/s00198-017-4190-1. Epub 2017 Aug 25.
Derived from this study: 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.

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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Recruiting
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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.

Harald Dobnig, MD principal investigator

Medical University of Graz

1 site in 1 country: 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 Harald Dobnig, MD at 1 site in Austria.

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: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Length of hospital stay (time frame: maximum 6 months). 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 NCT01130181, which also lists 11 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 28 May 2014.