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Tocotrienol Against the Progression of End Stage Liver Disease

NCT02581085 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-09

No results posted yet for this study

Summary

The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.

Conditions

  • End Stage Liver Disease
  • NASH - Nonalcoholic Steatohepatitis
  • NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

DRUG

Tocotrienol (TCT)

TCT is a natural vitamin E supplement with a long history of safe dietary consumption in humans. The objective of the current trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD score over time in patients with end stage liver disease/cirrhosis.

OTHER

Placebo

Control study capsule that includes no study product (Vitamin E - Tocotrienol)

Sponsors & Collaborators

  • Malaysia Palm Oil Board

    collaborator OTHER_GOV

  • Indiana University

    collaborator OTHER

  • Chandan Sen

    lead OTHER

Principal Investigators

  • Chandan K Sen, Ph.D · University of Pittsburgh

  • Raj Vuppalanchi, M.D. · Indiana Unviersity School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2026-12-16
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581085 on ClinicalTrials.gov