The effects of zinc 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 zinc 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 zinc supplement (n=30) or placebo (n=30).

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, 60 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, hypersensitivity to the study medication, and unwillingness to cooperate.

Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 16 weeks orally.

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

The updating process was done before publishing the paper to correct the registration information.

Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.

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 Donyaye Behdasht 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.