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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver, Non-Alcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04198805

Run by

Naga P. Chalasani

People needed

205

Starts

2020-01-03

Expected to finish

2022-09-01

Last updated by the study team

2023-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female gender
• ≥18 years of age
• A new diagnosis or reconfirmation of previously known fatty liver by imaging (ultrasound or CT or MRI), or by liver biopsy within ≤ 4 years
• Fibroscan CAP score >300db
• Hepatic fat fraction ≥12% by MRI PDFF
• ALT≥ 40 U/L
• eGFR/Creatinine Clearance ≥ 60ml/min
• Participants with previously diagnosed Type 2 diabetes (up to 50% of sample): they must either be taking anti-diabetic medications, or their fasting (>10 hours) glucose must be ≥ 100 mg/dL at the time of screening
• Stable weight (±5%) for at least 3 months
• Subjects willing and able to give written informed consent and to understand, to participant and to comply with the clinical study requirements.

You may not qualify if…

• Evidence of alternative causes of hepatic steatosis or other forms of chronic liver disease, e.g. Hep.B, Hep.C
• Evidence of acute Hepatitis A
• Serum ALT or AST ≥ 250 U/L
• Serum Alkaline Phosphatase > 2 ULN
• Total bilirubin > 2 ULN in the absence of Gilbert's Syndrome [In patients with Gilbert's Syndrome, direct bilirubin must not exceed 2 ULN]
• HbA1c≥9.5%
• Decompensated acute or chronic liver disease
• Clinical, imaging or histological evidence of cirrhosis
• Use of anti-NASH drugs (e.g. thiazolidinediones) in the 3 months prior to randomization
• Use of a non-stable dose of statins or fibrates in the 3 months prior to randomization
• Use of fish oil, algal oil or Krill oil supplements, drugs or foods fortified with omega-3s in the 2 months prior to randomization (>200mg DHA/d and/or >60mg EPA/d by FFQ)
• Known intolerance to vitamin E or DHA
• Malabsorption of Vit E (e.g. due to steatorrhea, chronic pancreatitis, severe cholestasis)
• Vitamin E supplementation of greater than 100 IU/day in the 3 months prior to randomization
• History of bariatric surgery (jejunoileal bypass or gastric weight loss surgery) or currently undergoing evaluation for bariatric surgery
• History of biliary diversion
• Known positivity for antibody to Human Immunodeficiency Virus (HIV)
• Patients with coagulopathy (PT ≥3 sec.from ULN), thrombocytopenia (<70K)
• Contraindication to MRI (implants, metal…)
• Active, serious medical disease or disease diagnosis of a life-expectancy less than 5 years
• Ongoing or recent alcohol consumption > 21 drinks (1 drink= 12 oz regular beer, or 5 oz wine, or 1.5 oz distilled spirits) per week in men and > 14 drinks per week in women as per subject self-report as part of medical history.
• Active substance abuse, such as oral, inhaled or injected illicit drugs (except marijuana), in the year prior to screening
• Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial
• Women who are breastfeeding
• Any other condition which, in the opinion of the investigator would impede compliance or hinder completion of the study

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• Arizona Liver Health — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Inland Empire Clinical Trials, LLC — Rialto, California, United States
• Integrity Clinical Research LLC — Doral, Florida, United States
• Indago Research and Health Center, Inc. — Hialeah, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Advanced Pharma CR LLC — Miami, Florida, United States
• Med-Care Research — Miami, Florida, United States
• Summit Clinical Research LLC — Athens, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• M3 Wake Research Associates — Raleigh, North Carolina, United States
• Centex Studies, Inc. — Houston, Texas, United States
• Liver Specialists of Texas/Mt. Olympus Medical Research — Houston, Texas, United States
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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