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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.
Inclusion criteria
Exclusion criteria
Primary endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | maximum 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 25(OH)D levels | serum 25(OH)D levels will be measured on day 0, 3 and 7 | maximum 6 months |
| calcium levels | serum calcium levels will be measured on day 0, 3 and 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Dobnig, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19403914 | Background | 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. | |
| 20373095 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2015 | |
| Reset | Oct 27, 2015 | |
| Release | Oct 5, 2017 | |
| Reset | Jul 19, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2015 | Oct 27, 2015 | |||
| Oct 5, 2017 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Matching placebo |
|
|
| maximum 6 months |
| length of ICU stay starting from application of study medication | until patient's death or referral to another ward |
| duration of mechanical ventilation | duration of mechanical ventilation including CPAP/mask ventilation | starting from application of study medication |
| hospital mortality, 28-day mortality, 6 month-mortality | maximum 6 months |
| 19756497 | Background | 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. |
| 20399267 | Background | 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. |
| 21110839 | Background | 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. |
| 22186356 | Background | 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. |
| 21926604 | Background | 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. |
| 23134762 | Background | 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. |
| 24661739 | Background | 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. |
| 28842727 | Derived | 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. |
| 25268295 | Derived | 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. |
| Jul 19, 2018 |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |