VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients
NCT ID: NCT01130181
Last Updated: 2014-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2010-05-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
NCT03188796
Vitamin D to Improve Outcomes by Leveraging Early Treatment
NCT03096314
Rapid Normalization of Vitamin D Deficiency in PICU
NCT03742505
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
NCT03234218
Vitamin D in Ventilated ICU Patients
NCT01372995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cholecalciferol
Cholecalciferol
loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
Placebo
Placebo
Matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cholecalciferol
loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
Placebo
Matching placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Harald Dobnig, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Harald Dobnig, MD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harald Dobnig, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz, Austria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Graz
Graz, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VITdAL@ICU - 19022010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.