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.

A recent study looked at whether different amounts of Vitamin E could help adults with nonalcoholic fatty liver disease (NAFLD). The trial involved 200 people across multiple medical centers. They were randomly assigned to take either a placebo (an inactive pill) or one of three Vitamin E doses (200 IU, 400 IU, or 800 IU) daily for 24 weeks. The main goal was to see how these doses changed a key liver blood test called ALT.

However, the results for this primary goal—how much ALT levels changed—have not been made public yet. The study also planned to follow people for 48 weeks, but we do not have those findings either. No information about side effects or how well people tolerated the different doses is available from this report.

The main reason to be careful is that without the results, we simply do not know if Vitamin E at any of these doses was helpful, had no effect, or could have caused problems for people with NAFLD. The study was sponsored by a U.S. government health institute, which is a sign of careful planning.

For now, readers should understand that this was a completed study designed to find the right dose, but the answers are not in yet. It does not provide evidence to start or stop taking Vitamin E for liver health. Patients should talk with their doctor about managing NAFLD based on currently proven treatments.