Vitamin E Dosing Study

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

Interventions

DRUG

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

DRUG

Placebo

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

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• Liver Institute Northwest

  collaborator UNKNOWN

• Indiana University

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

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

  lead NIH

Principal Investigators

• Arun Sanyal, MD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-05

Primary Completion

2025-03-04

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations