Vitamin E Dosing Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).

Key facts

Study ID

NCT04801849

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

200

Starts

2022-08-05

Expected to finish

2025-06-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older as of the initial screening interview and provision of consent
• FibroScan CAP>280 dB/m within 60 days prior to randomization.
• ALT ≥ 60 U/L within 30 days of randomization

You may not qualify if…

• Concurrent or prior use (within 90 days) of vitamin E supplements in excess of 40 IU/day
• Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day (\~1.5 drinks/day) (> 10.5 drinks per week) in females and more than 30 g/day (\~2 drinks/day) (>14 drinks per week) in males, respectively. One "standard" drink (or one alcoholic drink equivalent) contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits).
• Inability to reliably quantify alcohol consumption based upon local study physician judgment
• Continued use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization
• Current use of anticoagulation therapy (not including antiplatelet agents such as aspirin or clopidogrel)
• Platelet count below 150,000 /mm3 within 90 days of randomization
• History of condition(s) that cause increased risk of bleeding, including hemophilia A, hemophilia B, von Willebrand disease, or other clotting factor deficiencies.
• Prior or planned (during the study period) bariatric surgery (eg, gastroplasty, roux-en-Y gastric bypass)
• Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to randomization
• Clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities:
• Serum albumin less than 3.2 g/dL
• International Normalized Ratio (INR) greater than 1.3
• Direct bilirubin greater than 1.0 mg/dL
• History of esophageal varices, ascites or hepatic encephalopathy
• Evidence of other forms of chronic liver disease:
• Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg)
• Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA
• Evidence of ongoing autoimmune liver disease as defined by compatible liver histology
• Primary biliary cirrhosis as defined by the presence of at least 2 of these criteria (i) Biochemical evidence of cholestasis based mainly on alkaline phosphatase elevation (ii) Presence of anti-mitochondrial antibody (AMA) (iii) Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts[1]
• Primary sclerosing cholangitis
• Known history of Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis. Any other type of liver disease that is currently active other than NASH such as drug-induced liver disease, liver cancer, or bile duct obstruction.
• Serum alanine aminotransferase (ALT) greater than 400 U/L within 90 days of randomization
• Moderate or severe renal impairment (serum creatinine ≥ 2.0 mg/dL or eGFR < 60 mg/mL/1.73m2)
• History of biliary diversion or evidence of current biliary obstruction
• Known positivity for Human Immunodeficiency Virus (HIV) infection

Where it is running

• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Indiana University- Adults — Indianapolis, Indiana, United States
• St. Louis University — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Liver Institute Northwest — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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