Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity

Summary

The goal of this clinical trial is to investigate the effects of tocotrienol-rich fraction vitamin E supplementation on liver enzymes in overweight and obese children with non-alcoholic fatty liver disease as compared to placebo. The main question\[s\] it aims to answer are: 1. Does supplementation of tocotrienol-rich fraction vitamin E reduce the level of liver enzymes and improve liver steatosis in non-alcoholic fatty liver disease among overweight and obese children? 2. Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage? Participants will : 1. consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months. 2. Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid. 3. The following investigations were performed upon recruitment and following 6 months of intervention: (i) liver biomarker and enzymes; (ii) DNA damage; (iii) TNFα, IL-6 and IFN-gamma genes; (iv) Fibroscan.

Timeline

Start

2020-01-01

Primary completion

2022-01-01

Completion

2022-01-21

Publications

• Al-Baiaty FDR, Ishak S, Mohd Zaki F, Masra F, Abdul Aziz DA, Wan Md Zin WN, Yee Hing E, Kuthubul Zaman AS, Abdul Wahab N, Muhammad Nawawi KN, Hamid Z, Raja Ali RA, Mokhtar NM. Assessing the efficacy of tocotrienol-rich fraction vitamin E in obese children with non-alcoholic fatty liver disease: a single-blind, randomized clinical trial. BMC Pediatr. 2024 Aug 20;24(1):529. doi: 10.1186/s12887-024-04993-8.

Drugs

Indications