A placebo-controlled clinical trial published in Hepatology found that vitamin E therapy led to significant reductions in liver enzyme levels among patients with metabolic dysfunction-associated steatotic liver disease (MASLD), suggesting an improvement in liver inflammation and injury. These findings support the potential role of vitamin E as a therapeutic option for selected patients with MASLD, although its effects on fibrosis and long-term clinical outcomes require further evaluation. The study was published in Hepatology journal by Dasarathy and colleagues.

Researchers have devised a robust design of a placebo-controlled, double-blind trial in specialized hospitals. The trial enrolled adult subjects who exhibited highly suspected MASH with concurrent and progressing hepatic damage. In order to get an accurate measure of organ stress, subjects were obliged to be characterized by notable hepatic fat deposition, confirmed by a CAP value of more than 280 decibels per meter (dB/m) via vibration-controlled transient elastography. Besides, participants needed to show evidence of active hepatitis infection by being characterized by a serum ALT concentration equal to or more than 60 U/L.

Patients were assigned into four parallel groups where each was expected to be given a placebo or one of three different doses of natural vitamin E. The doses included 200 IU, 400 IU, and 800 IU daily. The entire treatment spanned 24 weeks. The primary aim was to identify the lowest dose of vitamin E leading to maximum ALT lowering, whereas secondary goals revolved around improving liver fat scores, stiffness, and safety aspects.

Key findings:

  • In the metabolic study, a successful assessment of the total 200 subjects was conducted on adults, who had met their required clinic appointments according to the protocol.
  • The sample patient population had an average age of 47.0 years and a standard deviation of 13.9 years, while in terms of gender, the distribution comprised 62% males.
  • In relation to serum ALT, its concentration dropped significantly to -38% in case of the low-dose 200 IU vitamin E therapy group, which coincided with -36% drop in both 400 IU and 800 IU vitamin E groups and a mere -12% in the placebo group (p < 0.001 for all active doses).
  • The normalization rate of the ALT values was higher in 49%, 37%, and 50% of patients using the low, medium and high 200, 400, and 800 IU vitamin E dosage, respectively, compared to only 22% in the placebo group.
  • In addition, similar and considerable reduction rates of the aspartate aminotransferase values were noted in all vitamin E treatment groups.
  • However, the mean drops of objective CAP score and liver stiffness were insignificant compared to those in the placebo group.

In summary, administration of vitamin E at 200 IU/day was found to be equally beneficial as compared to any other dose used in MASLD subjects suffering from high aminotransferase levels. No safety issues were observed. The clear findings obtained from this phase II study provide an indispensable basis for future research on metabolic treatments in medicine.

Reference:

Dasarathy, Srinivasan1; Mitchell, Emily P.2; Wilson, Laura A.2; Neuschwander-Tetri, Brent A.3; Chalasani, Naga4; Clark, Jeanne M.5; Diehl, Anna Mae6; Hameed, Bilal7; Loomba, Rohit8; Yuan, Liyun9; Kowdley, Kris V.10; Sanyal, Arun J.11; for the NASH Clinical Research Network. Vitamin E dosing study (VEDS) in patients with metabolic dysfunction-associated steatotic liver disease with elevated aminotransferases: A multicenter, randomized, placebo-controlled trial. Hepatology ():10.1097/HEP.0000000000001797, June 9, 2026. | DOI: 10.1097/HEP.0000000000001797


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Article Source : Hepatology

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