Vitamin E for Non-alcoholic Fatty Liver Disease

(VEDS Trial)

Recruiting at 9 trial locations

Overseen By Rohit Loomba, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins Bloomberg School of Public Health

Prior Safety Data

Trial Summary

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

ALT ≥ 60 U/L within 30 days of randomization

I am 18 years or older and have given my consent.

FibroScan CAP>280 dB/m within 60 days prior to randomization

Exclusion Criteria

Platelet count below 150,000 /mm3 within 90 days of randomization

Inability to reliably quantify alcohol consumption based upon local study physician judgment

My liver is not functioning properly, shown by low albumin, high INR, high bilirubin, or history of liver-related complications.

Treatment Details

Interventions

• d-alpha-tocopherol (Vitamin)
• Placebo (Other)
• Vitamin E (Vitamin)

Trial Overview The trial is testing the effects of Vitamin E compared to a placebo in treating NAFLD. It's conducted at multiple centers where participants are randomly assigned to either receive Vitamin E or an inactive substance without knowing which one they're getting.

Participant Groups

Group I: Vitamin E, 200 IU Active Control 1 Intervention

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

Group II: Vitamin E, 400 IU Active Control 1 Intervention

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

Group III: Vitamin E, 800 IU Active Control 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

matching placebo taken once daily with breakfast

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Liver Institute Northwest

Collaborator

Trials

2

Recruited

1,800+

St. Louis University

Collaborator

Trials

197

Recruited

41,400+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+