Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04198805
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 205 participants
Conditions and interventions
Conditions
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 3, 2020 (Actual)
- Primary completion
- Sep 1, 2022 (Actual)
- Completion
- Sep 1, 2022 (Actual)
- Last update posted
- May 25, 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 25, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04198805 live on ClinicalTrials.gov.