Vitamin E for NASH Treatment in HIV Infected Individuals

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    56
  • sponsor
    Indiana University School of Medicine
Updated on 29 July 2023
diabetes
vitamin e
fatty liver
HIV Vaccine
vitamins

Summary

The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E.

Description

The investigators will conduct a proof-of-concept clinical trial to evaluate the efficacy of vitamin E for treatment of non-alcoholic steatohepatitis (NASH) in persons living with HIV. Hypothesis: Vitamin E will improve radiographically measured hepatic fat content and circulating markers of liver inflammation and injury in persons living with HIV who have NASH.

  1. Perform a pilot randomized placebo controlled trial of vitamin E 800 IU/daily for 6 months in 56 persons living with HIV with biopsy-proven NASH B. Measure change in liver fat content by magnetic resonance proton-density fat fraction (Primary outcome) C. Determine the impact of vitamin E treatment on noninvasive markers of hepatic and systemic inflammation, hepatic fibrosis, and systemic oxidative stress (Secondary outcomes) D. Define baseline hepatic gene expression signatures predictive of response to therapy.

Upon completion, the proposed clinical trial may establish vitamin E as an excellent and inexpensive candidate for further development as a treatment for NASH in persons living with HIV.

Details
Condition NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
Treatment placebos, vitamin E
Clinical Study IdentifierNCT03669133
SponsorIndiana University School of Medicine
Last Modified on29 July 2023

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