Article Text


General Liver I
PTU-050 Effect of vitamin E and alfa lipoic acid (ALA) in non-alcoholic fatty liver disease: a randomise placebo control open label prospective clinical trial: V A I N trial
  1. P Basu1,
  2. N James Shah2,
  3. S Farhat2
  1. 1Gastroenterolgy and Liver Transplant, Columbia University, College of Physicians and Surgeons, New York, New York, USA
  2. 2Internal Medicine, North Shore University, Forest Hills, New York, USA


Introduction Non-Alcoholic Fatty Liver Disease (NAFLD) is a global epidemic. NAFLD progress to Non-Alcoholic Steatohepatitis (NASH), cirrhosis and cancer. Obesity and insulin insensitivity is the hallmark. Liver participates in glucose and fatty acid homeostasis. Nonexpelled free fatty acid and its toxic metabolites impact oxidative stress; free radicals influx which initiate inflammatory cascade to Steatohepatitis (NASH) and activate fibrotic path causing cirrhosis. This clinical trial highlights the effects of anti-oxidants in NAFLD.

Methods One hundred and fifty-five (n=155) with BMI over 28% with NAFLD and NASH were recruited and randomised into Group A (n=35)- Control, Group B (n=40) ALA 300 mg, Group C (n=40) Vitamin E 700 IU and Group D (n=40) ALA plus Vitamin E orally for 6 months. Pre and Post BMI, HOMA, Triglyceride, Haemoglobin A1c, Alanine aminotransferase (ALT), Retinol Binding Protein 4, Tumour Necrosis factor α (TNFα), Leptin and adiponectin levels were compared. Everyone was allowed 1600 cal/day with modest exercise. Exclusion criteria: Diabetics, BMI >33%, Alcohol intake >30 g/day, Hepatitis B, C, Hypothyroidism, medications including herbs and supplements.

% ChangesGroup B (ALA)Group C (Vit E)Group D (ALA + Vit E)
δ Triglyceride34.3%37.5%56.4%
δ HOMA54.3%53.7%67.4%
δ ALT20.8%40.7%44.8%
δ RBP446.2%46.5%61.9%
δ Leptin44.8%46.9%58.6%
δ Adiponectin55%47.8%52.6%
δ TNF-α59.3%61.9%82.6%
δ Steatosis Score75%73.2%78.7%
δ Fibrotic Score5.9%−6.7%5.6%

Conclusion Pre and post analysis between ALA plus Vitamin E over placebo in 6 month; TG 43%, HbA1c 14%, HOMA 62.8%, ALT 14.4%, RBR4 50%, Leptin23%, Adiponectin19% TNF α 70%, and Steatotic score 70.7%. This clinical trial demonstrates the additive effects of ALA and vitamin E in NAFLD and NASH with significant improvements of inflammatory and steatotic score but no difference in the fibrotic score. Therapeutic application of ALA and Vitamin E should be considered for NAFLD.

Competing interests None declared.

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