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Natural vitamin e pill may delay liver transplant in cirrhosis patients

NCT ID NCT02581085

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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