In this trial, 32 Malaysian children (mean age of approximately 12 years old) received either placebo or a daily dose of 50 mg of vitamin E isomers (comprised 7.4 mg δ-tocotrienol, 2.02 mg β-tocotrienol, 22.3 mg γ-tocotrienol, 18.28 mg α-tocotrienol, and 17.1 mg α-tocopherol) for 6 months, with the trial’s primary outcome defined as the mean difference in hepatic steatosis as evaluated by the controlled attenuated parameter (CAP). Multiple secondary outcomes included fibrosis scores and biochemical assessments of inflammation, DNA damage, etc.
Among the 29 children who completed the trial, those who received TRF had significantly lower apolipoprotein-A1 (ApoA1) and aspartate aminotransferase (AST) levels after 6 months compared to baseline. Additionally, significant reductions were observed in pro-inflammatory cytokines (IL-6 and TNF-1) as well as DNA damage parameters (comet assay) after TRF supplementation. No differences were observed between groups for multiple secondary outcomes, including ALT, fasting blood glucose, α-2-M, GGT, haptoglobin, total bilirubin, and triglycerides. While a slight reduction in CAP was observed in the placebo group (perhaps due to behavioral changes), the decrease in the TRF group was not significant. No adverse effects were observed with TRF, suggesting that it may have a valuable role as a supportive and safe therapy for pediatric NAFLD, helping with oxidative damage and a healthy inflammatory response.