Vitamin E for Non-alcoholic Fatty Liver Disease

(VEDS Trial)

Recruiting at 9 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

200 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{4 6 7 8 9}

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).

Research Team

Arun J Sanyal, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Does vitamin E improve the outcomes of pediatric nonalcoholic fatty liver disease? A systematic review and meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Vitamin E has a beneficial effect on nonalcoholic fatty liver disease: a meta-analysis of randomized controlled trials. [2015]

3. India pubmed.ncbi.nlm.nih.gov

Vitamin E-based therapy is effective in ameliorating transaminasemia in nonalcoholic fatty liver disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effect of vitamin E in non-alcoholic fatty liver disease: a systematic review and meta-analysis of randomised controlled trials. [2020]

5. Scotland pubmed.ncbi.nlm.nih.gov

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]

6. Australia pubmed.ncbi.nlm.nih.gov

Systematic review with meta-analysis: The effect of vitamin E supplementation in adult patients with non-alcoholic fatty liver disease. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The efficacy of vitamin E in reducing non-alcoholic fatty liver disease: a systematic review, meta-analysis, and meta-regression. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Vitamin E in the Treatment of NAFLD. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of vitamin E on redox biomarkers in non-alcoholic fatty liver disease. [2021]