Vitamin E for Non-alcoholic Fatty Liver Disease
(VEDS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use certain drugs linked to liver disease or medications that affect fat-soluble vitamin absorption. If you're on anticoagulation therapy or certain other medications, you may need to stop them before joining.
What data supports the effectiveness of the drug Vitamin E for treating non-alcoholic fatty liver disease?
Research shows that Vitamin E can improve liver function in adults with non-alcoholic fatty liver disease, as it helps reduce certain liver enzymes that indicate liver damage. However, its effectiveness in children is less clear, and combining it with lifestyle changes may yield better results.12345
Is Vitamin E safe for humans?
How is Vitamin E treatment unique for non-alcoholic fatty liver disease?
Vitamin E, specifically d-alpha-tocopherol, is unique for treating non-alcoholic fatty liver disease because it acts as an antioxidant, reducing oxidative stress in the liver, which is a key factor in the disease's progression. It is particularly recommended for non-diabetic patients with biopsy-proven nonalcoholic steatohepatitis (NASH), showing improvements in liver enzyme levels and inflammation, although it may not significantly improve liver fibrosis.46789
What is the purpose of this trial?
This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Research Team
Arun J Sanyal, MD
Principal Investigator
Virginia Commonwealth University
Eligibility Criteria
Adults with nonalcoholic fatty liver disease (NAFLD) who are 18 or older, have a FibroScan CAP>280 dB/m and ALT ≥ 60 U/L. Excluded are those with low platelets, bleeding disorders, planned bariatric surgery, uncontrolled diabetes, signs of advanced liver disease, excessive vitamin E or alcohol use, certain medication histories and other specific health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with 200 IU, 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- d-alpha-tocopherol
- Placebo
- Vitamin E
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
University of California, San Diego
Collaborator
Indiana University
Collaborator
Virginia Commonwealth University
Collaborator
University of Southern California
Collaborator
University of California, San Francisco
Collaborator
Case Western Reserve University
Collaborator
Johns Hopkins Bloomberg School of Public Health
Collaborator
Liver Institute Northwest
Collaborator
St. Louis University
Collaborator