NCT04704063: T3-NAFL

Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL)

Completed Phase 2 Last updated 10 May 2024

What this trial tests

Phase 2 trial testing Tocotrienols / Vitamin E in Hepatic Steatosis in 170 participants. Completed in 1 October 2023.

Timeline

1 January 2021

Primary endpoint
15 August 2023

1 October 2023

Quick facts

Lead sponsor	Yuen Kah Hay
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	170
Start date	1 January 2021
Primary completion	15 August 2023
Estimated completion	1 October 2023
Sites	4 locations across Malaysia

Drugs / interventions tested

• Tocotrienols / Vitamin E — full drug profile →
• Placebo control

Conditions studied

• Hepatic Steatosis — all drugs for Hepatic Steatosis →
• NAFLD — all drugs for NAFLD →

Sponsor

Yuen Kah Hay — full company profile →

Who can join

Adults 18 to 70, any sex, with Hepatic Steatosis or NAFLD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Palm-derived tocotrienols have shown hepatoprotective effects in both animal and human studies. This study aims to investigate the effects of tocotrienols in hepatocellular lipid content using MRI. Non-alcoholic fatty liver disease (NAFLD) is a spectrum of diseases ranging from simple fatty liver (steatosis, NAFL) to non-alcoholic steatohepatitis (NASH) to cirrhosis. NASH is the accumulation of fat in liver cells accompanied with inflammation that can lead to the scarring of the liver. Prevention of liver fibrosis by early introduction of low risk interventions such as lifestyle modification, diet control and nutraceuticals may help circumvent long-term healthcare costs associated with management of chronic NASH.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Molecular Insight into the Role of Antioxidants in Nonalcoholic Fatty Liver Diseases.
   Ezhilarasan D, Lakshmi T. · · 2022 · cited 34× · PMID 35602098 · DOI 10.1155/2022/9233650
2. Iron metabolism and ferroptosis in nonalcoholic fatty liver disease: what is our next step?
   Shen X, Yu Z, Wei C, Hu C, et al · · 2024 · cited 20× · PMID 38506752 · DOI 10.1152/ajpendo.00260.2023
3. Nutritional supplementation for nonalcohol-related fatty liver disease: a network meta-analysis.
   Komolafe O, Buzzetti E, Linden A, Best LM, et al · · 2021 · cited 12× · PMID 34280304 · DOI 10.1002/14651858.cd013157.pub2