Robin Vos1, David Ruttens2, Stijn E Verleden3, Elly Vandermeulen3, Hannelore Bellon3, Anke Van Herck2, Annelore Sacreas3, Tobias Heigl3, Veronique Schaevers4, Dirk E Van Raemdonck5, Eric K Verbeken6, Arne P Neyrinck7, Lieven J Dupont2, Jonas Yserbyt2, Bart M Vanaudenaerde3, Geert M Verleden2. 1. Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium. Electronic address: robin.vos@uzleuven.be. 2. Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium. 3. Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium. 4. Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium. 5. Department of Experimental Thoracic Surgery, Katholieke Universiteit Leuven, Leuven, Belgium. 6. Department of Histopathology, Katholieke Universiteit Leuven, Leuven, Belgium. 7. Department of Anesthesiology, University Hospitals Leuven, Leuven, Belgium.
Abstract
BACKGROUND:Vitamin D may have innate immunomodulatory functions with potentially beneficial therapeutic effects in lung transplant recipients. METHODS: This was a single-center, double blind, randomized, placebo-controlled, prevention trial of once-monthly oral vitamin D (cholecalciferol; 100,000 IU, n = 44) vs placebo (n = 43) during 2 years in adult lung transplant recipients enrolled from October 2010 to August 2013. Primary outcome was prevalence of chronic lung allograft dysfunction (CLAD) 3 years after transplantation. Secondary outcomes included overall survival, prevalence of acute rejection, lymphocytic bronchiolitis and infection, lung function, pulmonary and systemic inflammation, and bone mineral density. RESULTS:All included patients underwent bilateral lung transplantation and were mostly middle-aged men with prior smoking-related emphysema. Levels of 25-hydroxy vitamin D after 1 year (p < .001) and 2 years (p < .001) were significantly higher in the vitamin D group compared with the placebo group. No difference was observed for CLAD prevalence (p = 0.7) or CLAD-free survival between both groups (p = 0.7). Secondary outcomes were overall comparable between both groups (all p > 0.05). CONCLUSIONS: Once-monthly oral vitamin D supplementation after lung transplantation fails to demonstrate a significant difference in CLAD prevalence, innate immunomodulatory, or a beneficial clinical effect compared with placebo.
RCT Entities:
BACKGROUND:Vitamin D may have innate immunomodulatory functions with potentially beneficial therapeutic effects in lung transplant recipients. METHODS: This was a single-center, double blind, randomized, placebo-controlled, prevention trial of once-monthly oral vitamin D (cholecalciferol; 100,000 IU, n = 44) vs placebo (n = 43) during 2 years in adult lung transplant recipients enrolled from October 2010 to August 2013. Primary outcome was prevalence of chronic lung allograft dysfunction (CLAD) 3 years after transplantation. Secondary outcomes included overall survival, prevalence of acute rejection, lymphocytic bronchiolitis and infection, lung function, pulmonary and systemic inflammation, and bone mineral density. RESULTS: All included patients underwent bilateral lung transplantation and were mostly middle-aged men with prior smoking-related emphysema. Levels of 25-hydroxy vitamin D after 1 year (p < .001) and 2 years (p < .001) were significantly higher in the vitamin D group compared with the placebo group. No difference was observed for CLAD prevalence (p = 0.7) or CLAD-free survival between both groups (p = 0.7). Secondary outcomes were overall comparable between both groups (all p > 0.05). CONCLUSIONS: Once-monthly oral vitamin D supplementation after lung transplantation fails to demonstrate a significant difference in CLAD prevalence, innate immunomodulatory, or a beneficial clinical effect compared with placebo.
Authors: Katharina Staufer; Emina Halilbasic; Peter Hillebrand; Solveig Harm; Stefan Schwarz; Peter Jaksch; Danijel Kivaranovic; Walter Klepetko; Michael Trauner; Lili Kazemi-Shirazi Journal: United European Gastroenterol J Date: 2018-05-17 Impact factor: 4.623
Authors: Karin Amrein; Mario Scherkl; Magdalena Hoffmann; Stefan Neuwersch-Sommeregger; Markus Köstenberger; Adelina Tmava Berisha; Gennaro Martucci; Stefan Pilz; Oliver Malle Journal: Eur J Clin Nutr Date: 2020-01-20 Impact factor: 4.016