1. The effect of vitamin E and docosahexaenoic acid ethyl ester on Metabolic Dysfunction-Associated steatotic Liver Disease (MASLD)-A randomised, double-blind, placebo-controlled, parallel-group clinical trial (PUVENAFLD).
- Author
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Alkhouri N, McCarthy D, Bayne AV, Blonquist T, Yurko-Mauro K, Vuppalanchi R, Lawitz E, and Chalasani N
- Subjects
- Humans, Female, Male, Middle Aged, Double-Blind Method, Adult, Treatment Outcome, Aged, Drug Therapy, Combination, Liver drug effects, Liver metabolism, Docosahexaenoic Acids therapeutic use, Docosahexaenoic Acids administration & dosage, Vitamin E therapeutic use, Vitamin E administration & dosage, Fatty Liver drug therapy
- Abstract
Aims: We conducted a clinical trial to determine the efficacy of the combination of vitamin E and/or docosahexaenoic acid (DHA) versus placebo in reducing liver fat content after 6 months of intervention in adults with MASLD., Methods: Adults with MASLD were randomised to one of four treatment arms (vitamin E 1000 mg/daily + DHA 1.89 g/daily or combination arm, vitamin E 1000 mg alone, DHA 1.89 g alone or placebo) following a 2:1:1:2 randomisation. The primary objective was to determine the efficacy of DHA + vitamin E versus placebo in reducing hepatic fat fraction (%) relative to baseline after 6 months of intervention. Secondary objectives were to determine the effect of vitamin E or DHA alone versus placebo on reducing liver fat at 6 months., Results: Our cohort consisted of 203 subjects with a mean age of 51 years, 53% female, 91% White, 59% Hispanic ethnicity. The combination of vitamin E + DHA had no effect on the primary endpoint of reducing hepatic steatosis as determined by MRI-PDFF (p = 0.98). Neither vitamin E alone (p = 0.91) nor DHA alone (p = 0.14) significantly reduced hepatic steatosis compared to placebo. However, the trial was not powered adequately for this analysis. Compared with placebo, no statistically significant differences were detected in the 3-month or 6-month levels for ALT (U/L) or AST (U/L) in all three intervention groups., Conclusions: The combination of DHA + vitamin E or either agent alone did not demonstrate efficacy on reducing liver fat or aminotransferases in the studied population., (© 2024 John Wiley & Sons Ltd.)
- Published
- 2024
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