High-dose vitamin D after lung transplantation: A randomized trial.

Robin Vos, David Ruttens, Stijn E Verleden, Elly Vandermeulen, Hannelore Bellon, Anke Van Herck, Annelore Sacreas, Tobias Heigl, Veronique Schaevers, Dirk E Van Raemdonck, Eric K Verbeken, Arne P Neyrinck, Lieven J Dupont, Jonas Yserbyt, Bart M Vanaudenaerde, Geert M Verleden

Journal: The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 2018;36(8):897-905

PMID: 28365177

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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.

Address: 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: [email protected].; Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium; Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium.; Division of Respiratory Diseases, Department of Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.; Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Experimental Thoracic Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.; Department of Histopathology, Katholieke Universiteit Leuven, Leuven, Belgium.; Department of Anesthesiology, University Hospitals Leuven, Leuven, Belgium.

DOI: 10.1016/j.healun.2017.03.008

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MeSH Terms: Administration, Oral, Belgium, Dietary Supplements, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Lung Transplantation, Male, Middle Aged, Primary Graft Dysfunction, Retrospective Studies, Survival Rate, Time Factors, Treatment Outcome, Vitamin D, Vitamins