Evaluating the antioxidant and anti-inflammatory effect of melatonin in pediatric hemodialysis patients: a randomized, placebo-controlled trial

Children undergoing chronic hemodialysis are exposed to persistent oxidative stress and systemic inflammation, contributing to long-term cardiovascular complications. Melatonin (MLT) is a pleiotropic hormone with potential antioxidant and anti-inflammatory effects. Due to scarcity of studies on pediatrics this study sought to investigate the effects of MLT on oxidative stress and inflammation in pediatric hemodialysis patients. This prospective, block-randomized, double-blinded, placebo-controlled study aimed at assessing the effect of 5 mg MLT on oxidative stress and inflammation in pediatric hemodialysis patients. Forty eligible patients were randomly allocated into either MLT or placebo group. Serum malondialdehyde (MDA), nuclear factor kappa B (NF-κB) levels and lipid profile were measured at baseline and at the end of the study after 12 weeks. MLT significantly reduced the median percent change of serum NF-κB - 5.404(- 58.25-129.7) with p-value = 0.027 in addition to reduction in median total cholesterol in the MLT group from 163.7(134.5-259.5) at baseline to 144(113-242) at the end of the study with p-value = 0.038 and reduction of low-density lipoprotein levels from 96(78-183) to 78.5(48-171) at the end of the 12 weeks with p-value = 0.002 while there was no significance in the placebo group. Although, there was no statistical significance in serum MDA levels in the MLT group but significant increase in MDA levels in the placebo group was detected. MDA levels increased from 11.79 ± 5.078 to 14.79 ± 4.257 at the end of the study in the placebo group with p-value = 0.048, supplementation appears to have beneficial effects on ameliorating inflammation and reducing serum lipids. Moreover, MLT may have a protective antioxidant effect by reduction and inhibition of elevation of serum MDA levels.Trial registration: The study was registered on ClinicalTrials.gov (identifier: NCT05570526 https://clinicaltrials.gov/study/NCT05570526 ), on 6th of October 2022.