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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Kebangsaan Malaysia Medical Centre

About this trial

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.

Eligibility criteria

Qualifiers

Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT >2.0, elevated GGT)

Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline.

Patients aged 18 to 65

Patients who could comply with alcohol abstinence.

Disqualifiers

Severe alcoholic hepatitis defined as Maddrey's discriminant function >32

Hepatitis B

Hepatitis C

Non-alcoholic fatty liver disease (NAFLD)

Trial design

Treatments tested in this trial

  • Palm Tocotrienol Rich Fraction (TRF)
  • Refined, bleached, and deodorised (RBD) palm olein

Treatment groups

26 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak Status unavailable 56000, Cheras, Kuala LumpurMalaysiaMalaysia

Sponsors and collaborators

Universiti Kebangsaan Malaysia Medical Centre

Lead sponsor

Malaysia Palm Oil Board

Collaborator

Hovid Berhad

Collaborator