Vitamin E for Non-alcoholic Fatty Liver Disease

(VEDS Trial)

No longer recruiting at 10 trial locations

Overseen By Rohit Loomba, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Anticoagulants, NAFLD drugs, others

Disqualifiers: Alcohol use, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Vitamin E (d-alpha-tocopherol) might benefit individuals with non-alcoholic fatty liver disease (NAFLD), a condition characterized by fat accumulation in the liver without alcohol use. The study tests different doses of Vitamin E to determine its effectiveness in reducing liver fat compared to a placebo. This trial suits those diagnosed with NAFLD and elevated liver enzyme levels indicating liver stress. Participants should not have recently used high doses of Vitamin E or consumed significant amounts of alcohol. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Vitamin E is generally safe for individuals with non-alcoholic fatty liver disease (NAFLD). Studies have found that Vitamin E can improve liver health by reducing liver damage, particularly by lowering liver enzymes like ALT and AST, which help doctors assess liver function.

Researchers are testing different amounts of Vitamin E, and current evidence indicates no major safety issues with these amounts. Even at doses up to 800 IU, individuals have tolerated it well without serious side effects.

While every treatment can have side effects, research so far suggests that Vitamin E is quite safe. It is always important to consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Vitamin E for treating non-alcoholic fatty liver disease (NAFLD) because it offers a potential alternative to current treatments like lifestyle changes and medications aimed at managing symptoms. Unlike other treatments, Vitamin E, specifically d-alpha-tocopherol, is a powerful antioxidant that may help reduce liver inflammation and damage directly. This treatment is also being tested in varying doses (200 IU, 400 IU, and 800 IU), which might allow for personalized treatment plans based on patient needs. If successful, Vitamin E could provide a simple, daily supplement option for those struggling with NAFLD.

What evidence suggests that Vitamin E might be an effective treatment for non-alcoholic fatty liver disease?

Research has shown that Vitamin E might help treat non-alcoholic fatty liver disease (NAFLD). Studies have found that it can improve liver health by reducing signs of liver damage. This trial will evaluate different dosages of Vitamin E—specifically 200 IU, 400 IU, and 800 IU—to determine their effectiveness in improving liver function in adults with NAFLD. Additionally, a placebo group will be included for comparison. Although Vitamin E appears promising, uncertainty remains about all its benefits, prompting further research. ^{1 3 4 6 7}

Who Is on the Research Team?

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.

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?

Group I: Vitamin E, 200 IU Active Control 1 Intervention

200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Group II: Vitamin E, 400 IU Active Control 1 Intervention

400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Group III: Vitamin E, 800 IU Active Control 1 Intervention

800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast

Group IV: Placebo Placebo Group 1 Intervention

matching placebo taken once daily with breakfast

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin E-based therapy is effective in ameliorating transaminasemia in nonalcoholic fatty liver disease. Madan, K., Batra, Y., Gupta, DS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7724271/

The efficacy of vitamin E in reducing non-alcoholic fatty liver ... Current evidence affirms that vitamin E – whether alone or combined – improves biochemical and histological outcomes in adults and pediatric patients.

2. nature.com nature.com/articles/s41598-024-52482-w

Vitamin E intake is inversely associated with NAFLD ... Vitamin E intake, encompassing both dietary and supplemental forms, as well as total vitamin E intake, demonstrated a protective association with NAFLD.

3. cureus.com cureus.com/articles/305756-vitamin-e-and-non-alcoholic-fatty-liver-disease-investigating-the-evidence-through-a-systematic-review

Vitamin E and Non-alcoholic Fatty Liver Disease These results suggest that vitamin E is effective in improving liver damage in patients with NAFLD, particularly in reducing aminotransferase ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02690792?term=nafld&viewType=Table&checkSpell=&rank=3

Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease The study is designed to harness the physiologic changes that occur with short- and long-term fasting to provide a rapid and cost-effective method to accomplish ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015033.pub2/full

Vitamin E for people with non‐alcoholic fatty liver disease Vitamin E has shown beneficial effects on oxidative stress, which plays a major role in the pathogenesis of NAFLD. However, there is uncertainty ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02690792

Effect of Vitamin E on Non-Alcoholic Fatty Liver Disease The conclusion of the metabolic studies in week 0 marks the end of the study for control subjects, while NAFLD subjects will be initiated on Vitamin E or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9853086/

Effect of Vitamin E on Clinical Outcomes in Patients With Non ... The study found that reduction in ALT levels, AST levels, and BMI was significantly greater in patients in the vitamin E group compared to the placebo group.