200 Participants Needed

Vitamin E for Non-alcoholic Fatty Liver Disease

(VEDS Trial)

Recruiting at 9 trial locations
LM
ES
NT
EM
BH
SD
RL
Overseen ByRohit Loomba, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use certain drugs linked to liver disease or medications that affect fat-soluble vitamin absorption. If you're on anticoagulation therapy or certain other medications, you may need to stop them before joining.

Is Vitamin E safe for humans?

Vitamin E, also known as d-alpha-tocopherol, is generally considered safe for humans when used as a supplement. However, the short duration of trials limits the ability to draw firm conclusions about its long-term safety.12345

How is Vitamin E treatment unique for non-alcoholic fatty liver disease?

Vitamin E, specifically d-alpha-tocopherol, is unique for treating non-alcoholic fatty liver disease because it acts as an antioxidant, reducing oxidative stress in the liver, which is a key factor in the disease's progression. It is particularly recommended for non-diabetic patients with biopsy-proven nonalcoholic steatohepatitis (NASH), showing improvements in liver enzyme levels and inflammation, although it may not significantly improve liver fibrosis.23467

What data supports the effectiveness of the drug Vitamin E for treating non-alcoholic fatty liver disease?

Research shows that Vitamin E can improve liver function in adults with non-alcoholic fatty liver disease, as it helps reduce certain liver enzymes that indicate liver damage. However, its effectiveness in children is less clear, and combining it with lifestyle changes may yield better results.14589

Who Is on the Research Team?

Transplant Hepatology Fellowship ...

Arun J Sanyal, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

ALT ≥ 60 U/L within 30 days of randomization
FibroScan CAP>280 dB/m within 60 days prior to randomization

Exclusion Criteria

Platelet count below 150,000 /mm3 within 90 days of randomization
Inability to reliably quantify alcohol consumption based upon local study physician judgment
My liver is not functioning properly, shown by low albumin, high INR, high bilirubin, or history of liver-related complications.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with 200 IU, 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • d-alpha-tocopherol
  • Placebo
  • Vitamin E
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials
2,513
Recruited
4,366,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

Virginia Commonwealth University

Collaborator

Trials
732
Recruited
22,900,000+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Case Western Reserve University

Collaborator

Trials
314
Recruited
236,000+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials
441
Recruited
2,157,000+

Liver Institute Northwest

Collaborator

Trials
2
Recruited
1,800+

St. Louis University

Collaborator

Trials
197
Recruited
41,400+

Published Research Related to This Trial

In a study of 42 patients with nonalcoholic fatty liver disease (NAFLD), a combination treatment of weight management, ursodeoxycholic acid (UDCA), and vitamin E led to normalization of ALT levels in all patients in that group, significantly outperforming other treatment groups.
The results suggest that the combination of vitamin E with weight management and UDCA is an effective strategy for managing NAFLD, as it resulted in a lower post-treatment ALT level compared to weight management alone or weight management with UDCA.
Vitamin E-based therapy is effective in ameliorating transaminasemia in nonalcoholic fatty liver disease.Madan, K., Batra, Y., Gupta, DS., et al.[2019]

Citations

Does vitamin E improve the outcomes of pediatric nonalcoholic fatty liver disease? A systematic review and meta-analysis. [2021]
Vitamin E has a beneficial effect on nonalcoholic fatty liver disease: a meta-analysis of randomized controlled trials. [2015]
Vitamin E-based therapy is effective in ameliorating transaminasemia in nonalcoholic fatty liver disease. [2019]
Effect of vitamin E in non-alcoholic fatty liver disease: a systematic review and meta-analysis of randomised controlled trials. [2020]
Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial. [2022]
Systematic review with meta-analysis: The effect of vitamin E supplementation in adult patients with non-alcoholic fatty liver disease. [2021]
The efficacy of vitamin E in reducing non-alcoholic fatty liver disease: a systematic review, meta-analysis, and meta-regression. [2022]
The Role of Vitamin E in the Treatment of NAFLD. [2020]
Impact of vitamin E on redox biomarkers in non-alcoholic fatty liver disease. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security