Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2022-08-05
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin E, 200 IU
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E
Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
Vitamin E, 400 IU
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E
Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
Vitamin E, 800 IU
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E
Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
Placebo
matching placebo taken once daily with breakfast
Placebo
Participants will take a placebo vitamin E capsule daily for 24 weeks
Interventions
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Vitamin E
Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
Placebo
Participants will take a placebo vitamin E capsule daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FibroScan CAP\>280 dB/m within 60 days prior to randomization.
* ALT ≥ 60 U/L within 30 days of randomization
Exclusion Criteria
* 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
* Active, serious medical disease with likely life expectancy less than 5 years
* Active substance abuse including inhaled or injection drugs in the year prior to screening
* Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use ≥ 1 effective form(s) of birth control during the trial, breast feeding
* Current use of medications that may impact the absorption of fat-soluble vitamins (i.e. orlistat or cholestyramine)
* Pre-existing history of fat malabsorption
* Males at high risk of prostate cancer, including:
* PSA \>ULN at baseline
* History of prostate cancer
* Age 45 or older with a first-degree relative (father or brother) diagnosed with prostate cancer at an early age (younger than age 65).
* Age 40 or older with more than one first-degree relative who had prostate cancer at an early age (younger than age 65)
* Participation in an IND trial in the 30 days before randomization
* Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study, including inability to swallow treatment capsules
* Failure or inability to give informed consent
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Liver Institute Northwest
UNKNOWN
Indiana University
OTHER
St. Louis University
OTHER
University of California, San Diego
OTHER
University of Southern California
OTHER
University of California, San Francisco
OTHER
Virginia Commonwealth University
OTHER
The Cleveland Clinic
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Arun Sanyal, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
Countries
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Related Links
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Nonalcoholic Steatohepatitis Clinical Research Network Centers
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Other Identifiers
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IRB00240822
Identifier Type: OTHER
Identifier Source: secondary_id
10 VEDS
Identifier Type: -
Identifier Source: org_study_id
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