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Vitamin
Vitamin E for Non-alcoholic Fatty Liver Disease (VEDS Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
VEDS Trial 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.Check my eligibility
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.See study design
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.
VEDS Trial 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.
VEDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative change in alanine aminotransferase (ALT) from baseline to 24 weeks
Secondary outcome measures
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 moreVEDS Trial 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
1,127 Previous Clinical Trials
1,552,844 Total Patients Enrolled
13 Trials studying Non-alcoholic Fatty Liver Disease
2,909 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Indiana UniversityOTHER
988 Previous Clinical Trials
1,090,998 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
2,425 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Virginia Commonwealth UniversityOTHER
700 Previous Clinical Trials
22,886,845 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
7,576 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health conditions are typically treated with Vitamin E, 400 IU?
"Vitamin E, 400 IU is an effective solution for treating dietary deficits, such as long-chain omega-3 fatty acid deficiencies and general vitamin inadequacies."
Answered by AI
Are there any available slots in this experiment for potential participants?
"Affirmative, the information hosted on clinicaltrials.gov has indicated that this research project is presently recruiting participants. This experiment was first publicly posted on August 5th 2022 and recently updated October 5th 2022; it hopes to have 200 patients enrolled across nine different locations."
Answered by AI
Are there any recorded precedents of research involving 400 IU of Vitamin E?
"Vitamin E 400 IU was initially tested in 2008 at the George E Wahlen VA Medical Center. Since then, 18391 trials have been completed and there are currently 12 recruiting clinical studies taking place primarily out of Durham, North carolina."
Answered by AI
Has the U.S. Food and Drug Administration authorized 400 IU of Vitamin E for public use?
"Our team rates the safety of Vitamin E, 400 IU a 2 due to limited clinical evidence confirming its efficacy but some empirical data demonstrating it is safe."
Answered by AI
How many healthcare facilities in the city are currently involved with this experiment?
"This clinical trial has 9 locations where patients can be enrolled, including Duke University Medical Center in Durham, University of California San Diego in La Jolla and Indiana University- Adults in Indianapolis. There are also 6 other sites recruiting participants."
Answered by AI
What is the cap on enrollees for this clinical trial?
"To conduct this medical trial, 200 volunteers that meet the particular eligibility criteria must be enrolled. These individuals can register from two leading American universities: Duke University Medical Center in Durham, North carolina and University of California San Diego in La Jolla, California."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
California
How old are they?
18 - 65
What site did they apply to?
University of California, San Diego
University of Southern California
St. Louis University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To know and. It's because of wanting better health.
PatientReceived 1 prior treatment
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