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Randomized Controlled Trial
. 2025 Feb 18;6(2):101939.
doi: 10.1016/j.xcrm.2025.101939.

Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study

Yu Song  1 , Wenjing Ni  2 , Minghua Zheng  3 , Huiping Sheng  4 , Jing Wang  5 , Shilong Xie  6 , YongFeng Yang  7 , Xiaoling Chi  8 , Jinjun Chen  9 , Fangping He  10 , Xiaotang Fan  10 , Yuqiang Mi  11 , Jing Zhang  12 , Bingyuan Wang  13 , Lang Bai  14 , Wen Xie  15 , Bihui Zhong  16 , Yee Hui Yeo  17 , Fajuan Rui  2 , Shufei Zang  18 , Jie Li  19 , Junping Shi  20 ; Chinese NAFLD Clinical Research Network (CNAFLD CRN)
Affiliations
Randomized Controlled Trial

Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study

Yu Song et al. Cell Rep Med. .

Abstract

The efficacy and safety of a lower dose of vitamin E for metabolic dysfunction-associated steatohepatitis (MASH) treatment are unclear. This multi-center, randomized, double-blind, placebo-controlled study includes 124 non-diabetic participants with biopsy-proven MASH. Participants are randomly assigned to receive oral vitamin E 300 mg or the placebo in a 1:1 ratio. The primary outcome is improvement in hepatic histology. In the modified intention-to-treat population, 29.3% of participants in the vitamin E group achieve the primary outcome compared with 14.1% in the placebo group. Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group. 12 serious adverse events are reported in this trial but are not considered to be related to the treatment. Vitamin E 300 mg daily achieves sound improvements in liver histology in the Chinese population with MASH. This study is registered at ClinicalTrials.gov (NCT02962297).

Keywords: clinical trial; liver fibrosis; metabolic dysfunction-associated steatohepatitis; metabolic dysfunction-associated steatotic liver disease; non-alcoholic fatty liver disease; vitamin E.

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Conflict of interest statement

Declaration of interests The authors declare no competing interests.

Figures

None
Graphical abstract
Figure 1
Figure 1
Flow chart
Figure 2
Figure 2
Primary endpoints and secondary endpoints (mITT) (A) Subjects with liver histological improvement. (B) Fibrosis improvement by at least one stage without worsening of steatohepatitis. (C) Steatohepatitis resolution without worsening of fibrosis. (D) Fibrosis improvement by ≥1 stage or steatohepatitis resolution without fibrosis worsening either. Data are presented as percentage (%). See also Tables S1 and S2.
Figure 3
Figure 3
Changes from baseline in histologic features (mITT) (A) Steatosis, (B) lobular inflammation, (C) hepatocyte ballooning, (D) total NAFLD activity score, and (E) fibrosis. Data are presented as the inter-quartile range (IQR), and the upper and lower error bars represent 75th percentile plus 1.5 times IQR and the 25th percentile minus 1.5 IQR, respectively. NAFLD, non-alcoholic fatty liver disease. See also Table S3.
Figure 4
Figure 4
Change between baseline and week 96 in ALT and AST (FAS) (A) ALT and (B) AST. Data are presented as mean ± standard error. ALT, alanine aminotransferase; AST, aspartate aminotransferase.
See this image and copyright information in PMC

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