Vitamin E Dosing Study

NCT04801849 | Completed Phase 2 Results DMC FDA Drug

• 11 other identifiers: 10 VEDSU24DK061730U01DK061732U01DK061713U01DK061737U01DK061728U01DK061718U01DK061734U01DK061738U01DK061731IRB00240822
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Keywords

Vitamin E; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks

  ALT value in units/liter (U/L)

  Baseline to 24 weeks (end of treatment)

Secondary Outcomes (17)

• Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks

  Baseline to 24 weeks (end of treatment)

• Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline

  Baseline to 24 weeks (end of treatment)

• Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline

  Baseline to 24 weeks (end of treatment)

• Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function

  Baseline to24 weeks (end of treatment)

• Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan®

  Baseline to 24 weeks (end of treatment)

Study Arms (4)

Vitamin E, 200 IU

ACTIVE COMPARATOR

200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Drug: Vitamin E

Vitamin E, 400 IU

ACTIVE COMPARATOR

400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Drug: Vitamin E

Vitamin E, 800 IU

ACTIVE COMPARATOR

800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Drug: Vitamin E

Placebo

PLACEBO COMPARATOR

matching placebo taken once daily with breakfast

Drug: Placebo

Interventions

Vitamin E DRUG

Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks

Also known as: d-alpha-tocopherol

Vitamin E, 200 IU; Vitamin E, 400 IU; Vitamin E, 800 IU

Placebo DRUG

Participants will take a placebo vitamin E capsule daily for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Duke University: collaborator
• Liver Institute Northwest: collaborator
• Indiana University: collaborator
• St. Louis University: collaborator
• University of California, San Diego: collaborator
• University of Southern California: collaborator
• University of California, San Francisco: collaborator
• Virginia Commonwealth University: collaborator
• The Cleveland Clinic: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (9)

University of California, San Diego

La Jolla, California, 92103, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Indiana University- Adults

Indianapolis, Indiana, 46202, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Related Links

• Nonalcoholic Steatohepatitis Clinical Research Network Centers
• The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Vitamin E; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols

Results Point of Contact

• Title: Arun J. Sanyal, MD
• Organization: Virginia Commonwealth University-Medical College of Virginia Campus

arun.sanyal@vcuhealth.org

(804) 828-7811

Study Officials

• Arun Sanyal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, double masked, placebo-controlled, parallel treatment groups

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: August 5, 2022
• Primary Completion: March 4, 2025
• Study Completion: June 30, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data from this study may be requested from the NIDDK Central Repository (https://www.niddkrepository.org/search/study/) within two years of the date the database is locked for analysis (interventional studies, primary and secondary outcomes)
• Access Criteria: Apply through the NIDDK Central Repository:

Locations

US (9)