NCT07466485Not yet recruitingPhase 2
The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)
The Effect of Palm Tocotrienol Rich Fraction on Alcoholic Fatty Liver Disease (AFLD): A Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- May 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07466485
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- From May 2026 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other concomitant liver diseases:
- Hepatitis B
- Hepatitis C
- Non-alcoholic fatty liver disease (NAFLD)
- Autoimmune hepatitis (AIH)
- Hereditary hemochromatosis
- Patients taking vitamin E, herbal supplements, or other investigational products within 90 days prior to the participation in the study.
- Patients who have been taken any medications that could affect the treatment: hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, long-term use of NSAIDs, statins, neuroleptics, anticonvulsant medications, high-dose acetaminophen(\>=2.5g/day)
- Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
Other illness
- Severe alcoholic hepatitis defined as Maddrey's discriminant function \>32
- Patients who are obese (a BMI of 30 kg/ m2 or more) and with metabolic syndromes
- Patients with bleeding disorders and who have been on anticoagulant or antiaggregant treatments
- Patients who have been on corticosteroid therapy or pentoxifylline for alcoholic hepatitis
- Patients who have pyridoxine allergy or history
- Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc.
Other
- Patients with hepatocellular carcinoma
- Pregnant patients
- Patients who are breastfeeding
- Patients with Childs C liver cirrhosis
- Patients who could not comply with alcohol abstinence.
- Patient who considered ineligible for participation in the study as Investigator's judgment
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.