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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04198805

Public ClinicalTrials.gov record NCT04198805. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 6:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT04198805
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Naga P. Chalasani
Other
Enrollment
205 participants

Conditions and interventions

Interventions

  • Vitamin E [(all-rac)-α-tocopheryl acetate] Dietary Supplement
  • Omega-3 fatty acid (DHA EE) Dietary Supplement
  • Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate] Combination Product
  • Placebo Other

Dietary Supplement · Combination Product · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2, 2020
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update posted
May 24, 2023

2020 – 2022

United States locations

U.S. sites
15
U.S. states
8
U.S. cities
13
Facility City State ZIP Site status
Arizona Liver Health Chandler Arizona 85712
Arizona Liver Health Tucson Arizona 85712
Arkansas Gastroenterology North Little Rock Arkansas 72117
Inland Empire Clinical Trials, LLC Rialto California 92377
Integrity Clinical Research LLC Doral Florida 33166
Indago Research and Health Center, Inc. Hialeah Florida 33012
Florida Research Institute Lakewood Rch Florida 34211
Advanced Pharma CR LLC Miami Florida 33147
Med-Care Research Miami Florida 33165
Summit Clinical Research LLC Athens Georgia 30607
Indiana University School of Medicine Indianapolis Indiana 46202
M3 Wake Research Associates Raleigh North Carolina 27612
Centex Studies, Inc. Houston Texas 77058
Liver Specialists of Texas/Mt. Olympus Medical Research Houston Texas 77479
American Research Corporation at the Texas Liver Institute San Antonio Texas 78215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04198805, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 24, 2023 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04198805 live on ClinicalTrials.gov.

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