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IRCT20220409054467N7 IRCT 2026-08-08 Tehran University of Medical Sciences Efficacy of N-Acetylcysteine in Improving Clinical and Biochemical Parameters of Metabolic Dysfunction-Associated Steatotic Liver Disease in Children and Adolescents Efficacy of N-Acetylcysteine in Improving Clinical and Biochemical Parameters of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Children and Adolescents: A double-blind, placebo-controlled clinical trial study 2026-08-13 anticipated 64 Recruiting https://irct.ir/trial/92272 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and eight blocks. According to the sample size of 64 that has been determined, 8 octoploid blocks will be produced using the online site (www.sealedenvelope.com).In the Stratified Randomization method, age and BMI will be used as layers. subjects in each strata will be assigned to treatment or placebo group based on a random list produced by the online site (www.sealedenvelope.com). The random list containing 3-digit codes for each patient that identifies the relevant treatment will be provided to the researcher and will be inserted on the labels of 64 drug bottles. Randomization and blinding of the study are performed to maintain concealment, Blinding description: The study is double-blind. The participants will be divided into 2 groups receiving N-Acetylcysteine and the group receiving placebo. Given the double-blind nature of the study, before the study begins, the sets of cans containing the N-Acetylcysteine supplement will be prepared by someone other than the researcher, and the placebo will also be similar in appearance to the N-Acetylcysteine, so that neither the researcher nor the participant will be aware of the type of treatments received by each group. In addition, during the evaluation of the desired outcomes, the researcher will be unaware of the allocation of participants to each group (intervention and control groups) until after the end of the intervention period. 3 Metabolic Dysfunction-Associated Steatotic Liver Disease. Intervention 1: Intervention group: In this group, individuals take daily N-acetylcysteine ​​at a dose of 70 Milligrams per kilogram of body weight per day in two divided doses, as well as Ursodeoxycholic Acid at a dose of 10–15 Milligrams per kilogram of body weight per day in two divided doses (maximum 1000 Milligrams per day). The drug is supplied by Actover Company. Intervention 2: Control group: In the control group, in addition to ursodeoxycholic acid at the same dose as the intervention group, participants will be given a placebo that is completely identical to the original drug. The placebo is provided by Actover. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Pejman Rohani
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 0024 cmcpr@tums.ac.ir Tehran University of Medical Sciences scientific Pejman Rohani
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 0024 cmcpr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study. Girls and boys aged 7 to 18 years. Having a Z score of body mass index higher than 1 and less than 3 for age and sex. Diagnosis of MASLD based on imaging findings and metabolic criteria 7 years 18 years Both Other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, known autoimmune diseasesو and inherited disorders affecting the liver (iron, copper, etc.). History of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men. Pregnancy or breastfeeding in women Take hepatotoxic drugs such as phenytoin, amoxifen, and lithium celiac disease, diabetes, cardiovascular disease, lung disease, and kidney disease Substance abuse, chronic inflammatory disease, history of cancer, hormone therapy, recent weight loss diet. Consume St. John's wort, omega 3, coenzyme Q10, and carnitine Take medications or supplements that affect appetite, weight, or metabolism for at least 6 months before the study (such as medications that affect carbohydrate, protein, or fat metabolism, and medications that reduce or increase appetite or food intake, including herbal supplements). Treatment - Drugs Placebo Intervention group: In this group, individuals take daily N-acetylcysteine ​​at a dose of 70 Milligrams per kilogram of body weight per day in two divided doses, as well as Ursodeoxycholic Acid at a dose of 10–15 Milligrams per kilogram of body weight per day in two divided doses (maximum 1000 Milligrams per day). The drug is supplied by Actover Company. Control group: In the control group, in addition to ursodeoxycholic acid at the same dose as the intervention group, participants will be given a placebo that is completely identical to the original drug. The placebo is provided by Actover. Disease severity index. Timepoint: Beginning and end of the study. Method of measurement: Liver ultrasound. Serum Alanine Aminotransferase (ALT) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Serum Aspartate Aminotransferase (AST)levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Divide weight in kilograms by height in meters squared. Serum glucose levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Serum triglyceride level. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Tehran University of Medical Sciences Approved 2026-07-25 Research Ethics Committees of Digestive Diseases Research Institute- Tehran University of Medical Sc Digestive Diseases Research Institute, Shariati Hospital, Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)