Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)

Summary

Multicenter, randomized, double-blinded, placebo-controlled clinical trial is focused on novel treatments for non-alcoholic fatty liver disease (NAFLD), the most common cause of chronic liver disease. The primary objective of the study is to determine the clinical efficacy and safety of Vitamin E \[(all-rac)-α-tocopheryl acetate\] and Omega-3 fatty acid (DHA EE) compared to placebo on reducing liver fat content in participants with NAFLD. There is currently no approved drug treatment for NAFLD or NASH. While several new targets are being evaluated, they are not sufficiently powered to provide definitive data. There is, therefore, a need for well-designed, appropriately powered efficacy (phase 2) trials to define the utility of newer therapies for NAFLD. The combination of Vitamin E and DHA may provide optimal benefit for patients with NAFLD due to their associated mechanisms of action, namely Vitamin E's antioxidant action, preventing lipid oxidation of long-chain fatty acids such as DHA and thus preventing the propagation of free radicals and ROS.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Non-Alcoholic Fatty Liver
• Non-Alcoholic Steatohepatitis

Interventions

DIETARY_SUPPLEMENT

Vitamin E [(all-rac)-α-tocopheryl acetate]

Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months

DIETARY_SUPPLEMENT

Omega-3 fatty acid (DHA EE)

DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)

COMBINATION_PRODUCT

Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate]

DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months

OTHER

Placebo

Matching soybean placebo (3 capsules) of all arms daily for 6 months.

Sponsors & Collaborators

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• Naga P. Chalasani

  lead OTHER

Principal Investigators

• Naga P. Chalasani, MD · Indiana University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-03

Primary Completion

2022-09-01

Completion

2022-09-01

FDA Drug

Yes

Countries

• United States

Study Locations