Phase 2 trial tests three Vitamin E doses versus placebo in 200 adults with NAFLD

A phase 2, multicenter, randomized controlled trial investigated Vitamin E for nonalcoholic fatty liver disease (NAFLD). The study enrolled 200 adults with NAFLD and assigned them to receive d-alpha-tocopherol at doses of 200 international units (IU), 400 IU, or 800 IU, or a matching placebo. The primary outcome was the relative change in alanine aminotransferase (ALT) from baseline to 24 weeks, with total study enrollment lasting 48 weeks.

The results for the primary efficacy outcome are not reported. No data on the relative change in ALT, effect size, absolute numbers, p-values, or confidence intervals are available. The direction of any effect—whether beneficial, harmful, or neutral—is also not reported.

Safety and tolerability data, including adverse events, serious adverse events, and discontinuation rates, are not reported. The study was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The practice relevance of the findings is not reported. As the primary outcome results are unavailable, this trial provides no evidence regarding the efficacy or safety of these Vitamin E doses for ALT reduction in NAFLD.