Natural vitamin e pill may delay liver transplant in cirrhosis patients
NCT ID NCT02581085
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether a natural vitamin E supplement called tocotrienol can slow the worsening of end-stage liver disease. Seventy adults with stable but advanced liver disease (MELD score 8–17) will take either tocotrienol or a placebo twice daily for three years. The main goal is to see if the supplement prevents a rise in the MELD score, which measures liver function and predicts transplant need.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tocotrienol (a natural vitamin E supplement)
- What this could lead to
- If it works, this could provide a simple, safe supplement to slow liver damage and delay the need for a transplant in people with end-stage liver disease.
- What could go wrong
- This is a small, early-phase trial (70 people) testing a supplement against a placebo. Previous results need confirmation, and the supplement may not slow disease progression or prevent serious complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
110 people
The number who actually took part.
- Started
-
Nov 2019
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years of above, male or female * ESLD patients with clinically- diagnosed NAFLD or NASH * Absence of any other possible cause for liver dysfunction * Stable MELD score of at least 8, but no greater than 17 with \<25% change in MELD over the past 60 days prior to enrollment (\*Total number of patients with MELD of 8-9 or MELD of 16-17 cannot exceed 40% of cohort) * Able to speak and understand English * Willing and able to provide informed consent * Willing and able to return for regularly scheduled research study visits \& comply with study requirements Exclusion Criteria: 1. Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment 2. Hepatocellular carcinoma 3. Positive HIV/AIDS, or other chronic immunodeficiency 4. Concurrent hepatitis B or C infection 5. Current drug and/or alcohol abuse (per treating physician) 6. Bacterial infection at time of enrollment 7. Daily use of dedicated vitamin E supplementation (greater than 100 IU per day) within the 3 months prior to study participation 8. Platelets \<35,000 cells/µL, neutrophils \<1000 cells/µL, hemoglobin \<10g/dL, total bilirubin \>3mg/dL, serum creatinine \>2.0mg/dL 9. Women who are pregnant, breastfeeding, or plan to become pregnant during course of study participation (36 months) 10. Other significant comorbidities which limit the subject's life expectancy to less than 36 months 11. Concurrent enrollment in another interventional clinical trial 12. ALT \>250 U/L 13. AST \> 250 U/L 14. Hemoglobin A1C ≥ 9.5 % 15. History of liver transplantation 16. Current or history of HCC 17. Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study 18. Malignancy within 5 years of screening with the exception of a Adequately treated carcinoma in situ of the cervix b. Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for End-stage liver disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
IU Health Unviersity Hospital
Indianapolis, Indiana, 46202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sugar patterns in blood may foretell liver transplant rejection
- Can better training get doctors to talk about what matters most to dying veterans?
- Can tailoring bypass length improve weight loss surgery results?
- Can a Dual-Drug approach tackle fatty liver disease and diabetes together?
- Could a mask replace the breathing tube in liver transplants?
- AI may foresee lung complications after liver surgery