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
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Universiti Kebangsaan Malaysia Medical Centre
Lead sponsor
Malaysia Palm Oil Board
Collaborator
Hovid Berhad
Collaborator