Status:
COMPLETED
Tocotrienol as a Treatment for Non-alcoholic Fatty Liver Disease
Lead Sponsor:
National University of Malaysia
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Vitamin E's potential in treating non-alcoholic fatty liver disease (NAFLD) is attributed to its antioxidant properties. While tocopherols have shown significant results in NAFLD management, the power...
Detailed Description
This is a randomized double-blinded placebo-controlled trial targeted toward patients being diagnosed with non-alcoholic fatty liver disease. Patients will be screened and identified from the gastroen...
Eligibility Criteria
Inclusion
- Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of \>263 dB/m
- Raised ALT level (above the upper limit of normal): \>35 U/L for males and \>25 U/L for females
Exclusion
- Evidence of other chronic liver diseases (e.g. Hepatitis B, C infections, autoimmune hepatic disorders)
- Evidence of acute disorders affecting the liver (e.g. drug-induced liver injury, non-Hepatitis B, C viral infection)
- Biliary disease
- Liver cancer - primary hepatocellular carcinoma or liver metastasis
- Evidence of liver cirrhosis
- Alcohol intake of \>20 g/day for males and 10 g/day for females
- Use of steatogenic medications within the past three months (e.g. systemic steroids, methotrexate)
- History of bariatric surgery
- Intake of antibiotics and/or probiotic supplements within two months prior to the study
- Intake of a lipid-lowering agent (statin) within a month prior to the study.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06596382
Start Date
October 13 2020
End Date
June 30 2024
Last Update
November 22 2024
Active Locations (1)
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1
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia, 56000