Open Journal of Gastroenterology, 2014, 4, 199-207 Published Online May 2014 in SciRes. http://www.scirp.org/journal/ojgas http://dx.doi.org/10.4236/ojgas.2014.45030 How to cite this paper: Basu, P.P., Shah, N.J., Aloysius, M.M. and Brown Jr., R.S. (2014) Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo-Controlled, Open-Label, Prospective Clinical Trial (VAIN Trial). Open Journal of Gastroenterology, 4, 199-207. http://dx.doi.org/10.4236/ojgas.2014.45030 Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo-Controlled, Open-Label, Prospective Clinical Trial (VAIN Trial) Patrick P. Basu 1,2 , Niraj J. Shah 3 , Mark M. Aloysius 2* , Robert S. Brown Jr. 1 1 Columbia University College of Physicians and Surgeons, New York, USA 2 King’s County Hospital, New York, USA 3 James J. Peters VA Medical Center, Mount Sinai School of Medicine, New York, USA Email: * mark.aloysius5@gmail.com Received 20 April 2014; revised 25 April 2014; accepted 2 May 2014 Copyright © 2014 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ Abstract Objective: Antioxidants, including alpha lipoic acid (ALA) and vitamin E, are efficacious for the treatment of nonalcoholic fatty liver disease (NAFLD). The objective was to evaluate the effects of ALA and vitamin E alone or combined as therapy for patients with NAFLD and nonalcoholic stea- tohepatitis (NASH). Design: Placebo-controlled, open-label, prospective study in which patients with NAFLD and NASH were randomized to treatment with ALA 300 mg (n = 40), vitamin E 700 IU (n = 40), ALA 300 mg plus vitamin E 700 IU (n = 40), or placebo (n = 35) daily for 6 months. Body mass index, homeostasis model assessment scores, fibrosis and steatosis markers, and diagnostic laboratory tests were assessed at baseline and at the end of the study. Results: Treatment with ALA and vitamin E alone or in combination, improved inflammatory cytokine levels, steatosis scores, homeostasis model assessment scores, and triglyceride levels after 6 months relative to baseline. Conclusion: Alpha lipoic acid and vitamin E, either alone or in combination, were effec- tive treatments for patients with NAFLD and NASH. Keywords Antioxidant, Liver Disease, Vitamin E, Alphalipoic Acid * Corresponding author.