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Vitamin
Vitamin E for Non-alcoholic Fatty Liver Disease (VEDS Trial)
Phase 2
Waitlist Available
Led By Arun Sanyal, MD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older as of the initial screening interview and provision of consent
Be older than 18 years old
Must not have
Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day (~1.5 drinks/day) (> 10.5 drinks per week) in females and more than 30 g/day (~2 drinks/day) (>14 drinks per week) in males, respectively. One 'standard' drink (or one alcoholic drink equivalent) contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits)
Clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities: Serum albumin less than 3.2 g/dL, International Normalized Ratio (INR) greater than 1.3, Direct bilirubin greater than 1.0 mg/dL, History of esophageal varices, ascites or hepatic encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Summary
This trial is testing whether Vitamin E can help treat nonalcoholic fatty liver disease in adults.
Who is the study for?
Adults with nonalcoholic fatty liver disease (NAFLD) who are 18 or older, have a FibroScan CAP>280 dB/m and ALT ≥ 60 U/L. Excluded are those with low platelets, bleeding disorders, planned bariatric surgery, uncontrolled diabetes, signs of advanced liver disease, excessive vitamin E or alcohol use, certain medication histories and other specific health conditions.
What is being tested?
The trial is testing the effects of Vitamin E compared to a placebo in treating NAFLD. It's conducted at multiple centers where participants are randomly assigned to either receive Vitamin E or an inactive substance without knowing which one they're getting.
What are the potential side effects?
While not specified here, common side effects of high doses of Vitamin E may include nausea, diarrhea, stomach cramps, fatigue, headache, blurred vision and rash. Men at high risk for prostate cancer should be cautious due to potential increased risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and have given my consent.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not heavily consumed alcohol in the last year.
Select...
My liver is not functioning properly, shown by low albumin, high INR, high bilirubin, or history of liver-related complications.
Select...
I haven't used specific liver-affecting drugs for more than 2 weeks in the last 6 months.
Select...
I have a condition that increases my risk of bleeding, such as hemophilia or von Willebrand disease.
Select...
I am currently on blood thinner medication, not including aspirin or clopidogrel.
Select...
You have any of the following conditions:
- Chronic liver diseases like hepatitis B, hepatitis C, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis.
- Active liver diseases other than NASH, such as drug-induced liver disease, liver cancer, or bile duct obstruction.
- High levels of alanine aminotransferase (ALT) in the blood.
- Moderate or severe kidney problems.
- History of biliary diversion or current biliary obstruction.
- Positive for HIV infection.
- Serious medical condition with a life expectancy of less than 5 years.
- Recent substance abuse.
- Pregnancy, planning to become pregnant, or breastfeeding.
- Taking medications that may affect the absorption of fat-soluble vitamins.
- History of fat malabsorption.
- Men at high risk of prostate cancer based on age, family history, or PSA levels.
- Recent participation in another clinical trial.
- Any other condition that the doctor believes may affect your ability to follow the study requirements or give informed consent.
Select...
I have had or plan to have weight loss surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Relative change in alanine aminotransferase (ALT) from baseline to 24 weeks
Secondary study objectives
Mean change in hepatic steatosis (fat in the liver) score determined by Fibroscan® Controlled Attenuation Parameter (CAP) software function
Liver
Mean change in serum alanine aminotransferase (ALT) from baseline
+2 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Vitamin E, 200 IUActive Control1 Intervention
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Group II: Vitamin E, 400 IUActive Control1 Intervention
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Group III: Vitamin E, 800 IUActive Control1 Intervention
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Group IV: PlaceboPlacebo Group1 Intervention
matching placebo taken once daily with breakfast
Find a Location
Who is running the clinical trial?
University of California, San DiegoOTHER
1,180 Previous Clinical Trials
1,574,847 Total Patients Enrolled
13 Trials studying Non-alcoholic Fatty Liver Disease
2,299 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Indiana UniversityOTHER
1,039 Previous Clinical Trials
1,218,858 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
1,815 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Virginia Commonwealth UniversityOTHER
716 Previous Clinical Trials
22,888,298 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
7,016 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is not functioning properly, shown by low albumin, high INR, high bilirubin, or history of liver-related complications.I have not taken more than 40 IU/day of vitamin E in the last 3 months.I haven't used specific liver-affecting drugs for more than 2 weeks in the last 6 months.I have a condition that increases my risk of bleeding, such as hemophilia or von Willebrand disease.I am currently on blood thinner medication, not including aspirin or clopidogrel.I am 18 years or older and have given my consent.I have not heavily consumed alcohol in the last year.You have any of the following conditions:
- Chronic liver diseases like hepatitis B, hepatitis C, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis.
- Active liver diseases other than NASH, such as drug-induced liver disease, liver cancer, or bile duct obstruction.
- High levels of alanine aminotransferase (ALT) in the blood.
- Moderate or severe kidney problems.
- History of biliary diversion or current biliary obstruction.
- Positive for HIV infection.
- Serious medical condition with a life expectancy of less than 5 years.
- Recent substance abuse.
- Pregnancy, planning to become pregnant, or breastfeeding.
- Taking medications that may affect the absorption of fat-soluble vitamins.
- History of fat malabsorption.
- Men at high risk of prostate cancer based on age, family history, or PSA levels.
- Recent participation in another clinical trial.
- Any other condition that the doctor believes may affect your ability to follow the study requirements or give informed consent.I have had or plan to have weight loss surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin E, 200 IU
- Group 2: Vitamin E, 400 IU
- Group 3: Vitamin E, 800 IU
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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