CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate] +3 morecombination
Likely dose
Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate] 1.89 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04198805
NCT04198805Phase 2Completed
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The Effect of Vitamin E and Docosahexaenoic Acid Ethyl Ester on Non-Alcoholic Fatty Liver Disease (NAFLD) - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)

Naga P. Chalasani·interventional·Posted Dec 13, 2019·Updated May 25, 2023

In Brief

A Phase 2 clinical trial evaluating Vitamin E [(all-rac)-α-tocopheryl acetate], Omega-3 fatty acid (DHA EE), and 2 other interventions for Non-Alcoholic Fatty Liver Disease and 2 related conditions. Completed, enrolled 205 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver, Non-Alcoholic Steatohepatitis
CountriesUnited States
Collaboratorsdsm-firmenich Switzerland AG

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 13, 2019
Enrollment StartJan 3, 2020
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.6 years ago

Interventions

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

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

Omega-3 fatty acid (DHA EE)dietary

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

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

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

Placeboother

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