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The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Mar 2, 2026 to May 2, 2026v2 Show 4 more changesShow less
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Primary completion pushed from Sep 10, 2026 to Nov 10, 2026
    • Study completion pushed from Dec 15, 2026 to Feb 15, 2027
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical study aims to explore the potential liver-protective effects of palm tocotrienol-rich fraction (a form of Vitamin E) in adults with alcoholic fatty liver disease (AFLD). A total of 26 participants aged 18 to 65 years with AFLD will be randomly assigned to receive either tocotrienol (200 mg twice daily) or a placebo for six months. Throughout the study, participants will undergo regular liver health assessments including blood tests, FibroScan, and FibroTest, alongside evaluations of oxidative stress and inflammation markers. The study aims to determine whether tocotrienol can help improve liver function and reduce alcohol-related liver damage. Findings from this trial may provide valuable evidence for future clinical studies and highlight the potential of Malaysian palm-based tocotrienol as a natural, supportive approach to liver health.
Trial Details
NCT Number NCT07466485
Lead Sponsor Universiti Kebangsaan Malaysia Medical Centre
Collaborators: Malaysia Palm Oil Board, Hovid Berhad
Conditions
(from sponsor)		 Alcoholic Fatty Liver Disease
Related terms Fatty Liver, Alcoholic, Liver Diseases
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov