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IRCT20200531047614N1 IRCT 2020-06-19 Kashan University of Medical Sciences Zinc supplementation in treatment of obese children and adolescents with nonalcoholic fatty liver disease The effects of zinc supplementation compared with placebo on ultrasound findings and metabolic profiles in obese children and adolescents with nonalcoholic fatty liver disease 2020-05-21 anticipated 60 Complete https://irct.ir/trial/48543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Non alcoholic fatty liver disease (NAFLD). Intervention 1: Intervention group: 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 16 weeks orally. Intervention 2: Control group: Placebo (Donyaye Behdasht, Tehran, Iran), daily for 16 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Dr. Mohammad Reza Sharif
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 0026 mrsharifmd@yahoo.com Kashan University of Medical Sciences scientific Dr. Mohammad Reza Sharif
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5554 0026 mrsharifmd@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Obese children and adolescents diagnosed with nonalcoholic fatty liver Patients aged 10-18 years old. 10 years 18 years Both 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. Unwillingness to cooperate K75.81 Nonalcoholic steatohepatitis (NASH) Treatment - Drugs Placebo 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. Hs-CRP. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Elisa kit. Severity of liver steatosis. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Sonography. Serum liver enzymes. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit. Kashan University of Medical Sciences Approved 2020-05-18 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)