NCT04801849

Vitamin E Dosing Study

Vitamin E Dosing Study (VEDS): A Dose Finding Study of Vitamin E for the Treatment of Adult NAFLD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units (IU), 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks. The primary objective of the study is to determine the minimum effective dose of Vitamin E (d-alpha-tocopherol) based upon relative change in alanine aminotransferase (ALT) from baseline to 24 weeks.

Conditions

• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-05
• Primary completion: 2025-03-04
• Completion: 2025-06-30
• First posted: 2021-03-17
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study