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IRCT20220409054467N1 IRCT 2022-04-27 Tehran University of Medical Sciences The effect of resveratrol on children and adolescents with inflammatory bowel disease (IBD) The effect of resveratrol on children and adolescents with inflammatory bowel disease (IBD) 2022-04-21 anticipated 70 Complete https://irct.ir/trial/62875 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and double blocks. According to the sample size of 70 that has been determined, the quadruple and double blocks will be produced using the online site (www.sealedenvelope.com).In the Stratified Randomization method, age and BMI will be used as layers, Blinding description: The study is double-blind. Participants will be divided into two groups receiving resveratrol supplementation and the placebo group. Due to the double-blindness of the study, before starting the study, sets of cans containing resveratrol supplementation will be prepared by someone other than the researcher, and the placebo will be similar in appearance to resveratrol, so that the researcher does not know the type of treatment received by each group. In addition, the researcher in the evaluation phase of the desired outcomes (anthropometric measurements, blood tests, biochemistry and severity of inflammatory bowel disease) from the allocation of participants in each of the groups (intervention and control group) until after the end of the intervention period will be uninformed. 3 Inflammatory bowel disease. Intervention 1: Intervention group: The intervention group receiving resveratrol supplements will receive two 75 mg supplements daily for 12 weeks due to the better effectiveness of this supplement at lower doses and the lack of side effects reported at low doses. These supplements are provided by Karen Pharmaceuticals and Vital-Food Supplements Company. Intervention 2: Control group: Control group will receive two maltodextrin supplements daily for 12 weeks. These supplements are provided by Karen Pharmaceuticals and Vital-Food Supplements Company. 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 8 to 18 years. Diagnosis of IBD based on endoscopic, laboratory studies, and clinical examinations. Absences other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, other gastrointestinal diseases, chronic diseases (including type one or two diabetes, cardiovascular, pulmonary and celiac disease), autoimmune diseases Known and inherited and metabolic disorders. No history of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men. No pregnancy or breastfeeding in women. No substance abuse, no chronic inflammatory disease, no history of cancer, no hormone therapy, no recent weight loss diet. No history of gastrointestinal surgery. Do not 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). 8 years 18 years Both Having any acute illness The occurrence of any accident that affects a person's health. Use of antibiotics during the study Acceptance rate less than 80% Immigration Exclusion based on personal preference of participants or their parents Changes in medications taken during the study period K51.412 Inflammatory polyps of colon with intestinal obstruction Treatment - Drugs Placebo Intervention group: The intervention group receiving resveratrol supplements will receive two 75 mg supplements daily for 12 weeks due to the better effectiveness of this supplement at lower doses and the lack of side effects reported at low doses. These supplements are provided by Karen Pharmaceuticals and Vital-Food Supplements Company. Control group: Control group will receive two maltodextrin supplements daily for 12 weeks. These supplements are provided by Karen Pharmaceuticals and Vital-Food Supplements Company. Disease activity index. Timepoint: Beginning and end of the study. Method of measurement: Software for calculating pediatric Crohn's disease activity index (PCDAI) and pediatric ulcerative colitis activity index (PUCAI). Serum C-reactive protein (CRP) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Serum tumor necrosis factor (TNF) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Serum total antioxidant capacity (TAC) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Serum malondialdehyde (MDA) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Weight. Timepoint: Beginning and end of the study. Method of measurement: scale. Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculation. Serum Albumin. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. Tehran University of Medical Sciences Approved 2022-04-04 Research Ethics Committees of Children’s Medical Center- Tehran University of Medical Sciences Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)