The effects of melatonin supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease

Objective: The aim of this study is to determine the effects of melatonin supplementation on on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease.

Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplement (n=33) or placebo (n=33)

Among obese children and adolescents with nonalcoholic fatty liver disease referred to Pediatric Clinic of Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 66 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 16 weeks after the intervention. At the beginning and the end of the intervention: 16 weeks.

Inclusion criteria: Obese children and adolescents with nonalcoholic fatty liver disease aged 10 to 18 years old. Exclusion criteria: Taking any antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment, patients with infectious and autoimmune diseases, and hypersensitivity to the study medication.

Intervention group: two melatonin tablets (Simorgh Darou Attar Co., Iran) 6 mg, 3 mg each tablet, once a day, one hour before bedtime for 16 weeks orally. Control group: two Placebo tablets (Simorgh Darou Attar Co., Iran), once a day, one hour before bedtime for 16 weeks orally.

Outcomes: hs-CRP (primary outcome) and ultrasound findings, serum liver enzymes, lipid profiles and markers of oxidative damage (secondary outcomes) will be quantified at study baseline and end-of-trial.

Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Pediatric clinic of Shahid Beheshti Hospital, affiliated to Kashan University of Medical Science, who is not involved in the trial and not aware of random sequences, will assign the participants to intervention groups. Supplements and placebos are in the same packaging at the Simorgh Darou Attar Pharmaceutical Company. Only the code is written on the packages. Patients, parents and researchers will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Children, their parents, investigators or the assessors of the outcomes are unaware of the study groups.