Vitamin E (300 mg) in the treatment of MASH: A multi-center, randomized, double-blind, placebo-controlled study.
- 2025-02
- Cell reports. Medicine 6(2)
- Yu Song
- Wenjing Ni
- Minghua Zheng
- Huiping Sheng
- Jing Wang
- Shilong Xie
- YongFeng Yang
- Xiaoling Chi
- Jinjun Chen
- Fangping He
- Xiaotang Fan
- Yuqiang Mi
- Jing Zhang
- Bingyuan Wang
- Lang Bai
- Wen Xie
- Bihui Zhong
- Yee Hui Yeo
- Fajuan Rui
- Shufei Zang
- Jie Li
- Junping Shi
- PubMed: 39970876
- DOI: 10.1016/j.xcrm.2025.101939
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 124 non-diabetic participants with biopsy-proven MASH
- Methods
- multi-center, randomized, double-blind, placebo-controlled study; participants randomly assigned to receive oral vitamin E 300 mg or placebo in a 1:1 ratio
- Blinding
- Double-blind
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).
Research Insights
Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 300 mg/day
Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 300 mg/day
29.3% of participants in the vitamin E group achieve the primary outcome compared with 14.1% in the placebo group.
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 300 mg/day
Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 300 mg/day
Adverse Events Reported
12 serious adverse events are reported in this trial but are not considered to be related to the treatment.
- Finding
- Reported
- Severity
- Serious adverse event