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

• Status: Completed
• Trial end date: 2022-01-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University of Malaysia
• Treatments: Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

1. Children aged 13 - 18 years old

2. Overweight or obese (BMI percentile range ≥ 85%)

3. Able to swallow small oral soft gel capsule

4. Diagnosis of NAFLD confirmed by presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score of >263

5. Elevated alanine transaminase (ALT) ≥ 2 fold upper limits (26 U/L for boys and 22 U/L for girls)

Exclusion Criteria:

• Evidence of other primary chronic liver diseases (as determined by clinical and standard investigations) - e.g. Hepatitis B, C infections, autoimmune hepatic disorders.

• Not on any dietary supplements.