Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.

Summary

The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency. Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.

Timeline

Start

2017-08-27

Primary completion

2019-11-09

Completion

2019-11-09

Publications

• Background Perron RM, Lee P. Efficacy of high-dose vitamin D supplementation in the critically ill patients. Inflamm Allergy Drug Targets. 2013 Aug;12(4):273-81. doi: 10.2174/18715281113129990047.
• Background Quraishi SA, De Pascale G, Needleman JS, Nakazawa H, Kaneki M, Bajwa EK, Camargo CA Jr, Bhan I. Effect of Cholecalciferol Supplementation on Vitamin D Status and Cathelicidin Levels in Sepsis: A Randomized, Placebo-Controlled Trial. Crit Care Med. 2015 Sep;43(9):1928-37. doi: 10.1097/CCM.0000000000001148.
• Background Higgins DM, Wischmeyer PE, Queensland KM, Sillau SH, Sufit AJ, Heyland DK. Relationship of vitamin D deficiency to clinical outcomes in critically ill patients. JPEN J Parenter Enteral Nutr. 2012 Nov;36(6):713-20. doi: 10.1177/0148607112444449. Epub 2012 Apr 20.
• 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.
• Background Matthews LR, Ahmed Y, Wilson KL, Griggs DD, Danner OK. Worsening severity of vitamin D deficiency is associated with increased length of stay, surgical intensive care unit cost, and mortality rate in surgical intensive care unit patients. Am J Surg. 2012 Jul;204(1):37-43. doi: 10.1016/j.amjsurg.2011.07.021. Epub 2012 Feb 10.
• Background Braun A, Chang D, Mahadevappa K, Gibbons FK, Liu Y, Giovannucci E, Christopher KB. Association of low serum 25-hydroxyvitamin D levels and mortality in the critically ill. Crit Care Med. 2011 Apr;39(4):671-7. doi: 10.1097/CCM.0b013e318206ccdf.
• Background Braun AB, Litonjua AA, Moromizato T, Gibbons FK, Giovannucci E, Christopher KB. Association of low serum 25-hydroxyvitamin D levels and acute kidney injury in the critically ill. Crit Care Med. 2012 Dec;40(12):3170-9. doi: 10.1097/CCM.0b013e318260c928.
• Background Arnson Y, Gringauz I, Itzhaky D, Amital H. Vitamin D deficiency is associated with poor outcomes and increased mortality in severely ill patients. QJM. 2012 Jul;105(7):633-9. doi: 10.1093/qjmed/hcs014. Epub 2012 Feb 12.
• 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.
• Background Turkoglu M, Aygencel G, Dizbay M, Tuncel AF, Arslan Candir B, Deligoz Bildaci Y, Pasaoglu H. Is vitamin D deficiency associated with development of Acinetobacter baumannii infections in critically ill patients? J Crit Care. 2013 Oct;28(5):735-40. doi: 10.1016/j.jcrc.2013.03.017.
• Background 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.
• Background Spriet I, Meersseman W, de Hoon J, von Winckelmann S, Wilmer A, Willems L. Mini-series: II. clinical aspects. clinically relevant CYP450-mediated drug interactions in the ICU. Intensive Care Med. 2009 Apr;35(4):603-12. doi: 10.1007/s00134-008-1383-2. Epub 2009 Jan 9.
• Background Michaud J, Naud J, Ouimet D, Demers C, Petit JL, Leblond FA, Bonnardeaux A, Gascon-Barre M, Pichette V. Reduced hepatic synthesis of calcidiol in uremia. J Am Soc Nephrol. 2010 Sep;21(9):1488-97. doi: 10.1681/ASN.2009080815. Epub 2010 Jul 1.
• Background McNally JD. Vitamin D as a modifiable risk factor in critical illness: questions and answers provided by observational studies. J Pediatr (Rio J). 2014 Mar-Apr;90(2):99-101. doi: 10.1016/j.jped.2013.12.002. Epub 2013 Dec 19. No abstract available.
• Background Amrein K, Sourij H, Wagner G, Holl A, Pieber TR, Smolle KH, Stojakovic T, Schnedl C, Dobnig H. Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Crit Care. 2011;15(2):R104. doi: 10.1186/cc10120. Epub 2011 Mar 28.
• Background Bacon CJ, Gamble GD, Horne AM, Scott MA, Reid IR. High-dose oral vitamin D3 supplementation in the elderly. Osteoporos Int. 2009 Aug;20(8):1407-15. doi: 10.1007/s00198-008-0814-9. Epub 2008 Dec 20.
• Background von Restorff C, Bischoff-Ferrari HA, Theiler R. High-dose oral vitamin D3 supplementation in rheumatology patients with severe vitamin D3 deficiency. Bone. 2009 Oct;45(4):747-9. doi: 10.1016/j.bone.2009.06.012. Epub 2009 Jun 17.
• Background Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
• Background Vieth R. Critique of the considerations for establishing the tolerable upper intake level for vitamin D: critical need for revision upwards. J Nutr. 2006 Apr;136(4):1117-22. doi: 10.1093/jn/136.4.1117.
• Background Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 2010 May 12;303(18):1815-22. doi: 10.1001/jama.2010.594.
• Background Smith H, Anderson F, Raphael H, Maslin P, Crozier S, Cooper C. Effect of annual intramuscular vitamin D on fracture risk in elderly men and women--a population-based, randomized, double-blind, placebo-controlled trial. Rheumatology (Oxford). 2007 Dec;46(12):1852-7. doi: 10.1093/rheumatology/kem240. Epub 2007 Nov 12.

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