NCT06596382Completed
Tocotrienol as a Treatment for Non-alcoholic Fatty Liver Disease
A Randomised Double-blind Controlled Trial on Tocotrienol as a Treatment for Non-alcoholic Fatty Liver
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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 powerful properties of tocotrienols, another form of saturated vitamin E, remain understudied. This research aims to assess tocotrienol's effectiveness in treating NAFLD, expanding our understanding of its therapeutic benefits.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 264 (actual)
- First submitted
- 13 Dec 2023
- Start date
- 13 Oct 2020
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- National University of Malaysia
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06596382
What you commit to
- Study type: Interventional
- Participants enrolled: 264
- From 13 Oct 2020 to the primary completion date, 30 Jun 2024
- 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
- Use of steatogenic medications within the past three months (e.g. systemic steroids, methotrexate)
- 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.
Other illness
- 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
- History of bariatric surgery
Other
- Evidence of liver cirrhosis
- Alcohol intake of \>20 g/day for males and 10 g/day for females
Who the study is looking for
- 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
Age in the registry: 18 years to 90 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 UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.