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IRCT20190710044172N1 IRCT 2022-11-30 Tehran University of Medical Sciences zinc supplementation in ulcerative colitis The effect of zinc supplementation on clinical symptoms, quality of life and its effect on inflammatory biomarkers and the expression of NF-kB, calprotectin, TLR-4 and TNF-α genes in patients with ulcerative colitis 2022-12-22 anticipated 60 Complete https://irct.ir/trial/67083 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the patients, people are randomly assigned to two groups receiving zinc gluconate supplement and placebo. For randomization, permuted block randomization with 4 blocks (based on sex and BMI) will be used. The randomization will be individual. In order to apply concealment in the randomization process, unique codes will be used on the complementary boxes, and the desired code will be generated by the software and will be done with the envelope-sealed method with a random sequence. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is registered will be allocated to the person, and therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, the interrogator and the attending physician will not be aware of the intervention, Blinding description: In order to apply concealment (in a double-blind manner) in the randomization process, unique codes will be used on the complementary boxes, and the desired code is also generated by the software and by the envelope-in-package method with a random sequence will be done. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is recorded will be assigned to the person, and therefore, before choosing the person, no one will be aware of the type of treatment he will receive. Also, the interrogator and the attending physician will not be aware of the intervention. 3 Ulcerative Colitis. Intervention 1: Intervention group: Along with their medical drugs, including Mesalazine and Azaram, zinc gluconate oral supplement from Karen pharmaceutical company with 30 mg of zinc elemental and capsule filler (glycerol, gelatin and lecithin) is taken once a day for 60 days. Patients are given two cans containing 30 capsules each month. The first can will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Intervention 2: Control group: Along with their medical drugs, such as Mesalazine and Azaram, the placebo oral supplement from Karen pharmaceutical company without any medicinal combination and filled with glycerol, gelatin, and lecithin is taken once daily for 60 days. Patients are given two cans containing 30 capsules each month. The first can will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Yes - There is a plan to make this available What will be shared: The analysis and results of the study will be published. Items related to the personal information of patients will not be published. When: The access period starts 6 months after the results are published To whom: Patients with ulcerative colitis, nutritionists, physicians Conditions: It will be available to people in the form of brochures, articles, and training courses. Where to obtain: Executive and project manager masoomehkhalighi@gmail.com How to obtain: They can request information and documents by email Comments:
public Masoumeh Khalighi Sikaroudi
Rasoul-e-Akram Hospital, Maziar Mansouri Street, Sattar Khan Street
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8895 5975 masoomehkhalighi@gmail.com Tehran University of Medical Sciences scientific Masoumeh Khalighi Sikaroudi
Rasoul-e-Akram Hospital, Maziar Mansouri Street, Sattar Khan Street
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8895 5975 masoomehkhalighi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Body mass index 18.5 to 35 Diagnosis of ulcerative colitis according to the patient's symptoms, tests and colonoscopy image and intestinal sample pathology Mild to moderate active form of the disease according to the Mayo questionnaire No change in clinical symptoms during the last week of entering the study Absence of concomitant diseases such as malignant diseases and other inflammatory diseases (cancer, kidney failure, heart failure, liver disorders, Wilson's, rheumatoid arthritis, diabetes, psoriasis, Behcet and other inflammatory and autoimmune diseases) No hospitalization and no medication changes during the last 3 months due to the severity of the disease Not having an acute disease (cold, corona and any other viral-bacterial-fungal disease) No intestinal surgery Not taking zinc supplements in the last 2 months Not taking supplements containing antioxidants - omega 3 - vitamin D - probiotic - vitamin E - vitamin A - multivitamin in the last two months 18 years 50 years Both Use of infliximab, Adalimumab, high dose of corticosteroids (above 40 mg), NSAIDs pregnant and lactating women Taking contraceptives Implementation of special diet such as vegetarian diet, ketogenic diet and gluten-free diet K51.9 Ulcerative colitis, unspecified Treatment - Drugs Placebo Intervention group: Along with their medical drugs, including Mesalazine and Azaram, zinc gluconate oral supplement from Karen pharmaceutical company with 30 mg of zinc elemental and capsule filler (glycerol, gelatin and lecithin) is taken once a day for 60 days. Patients are given two cans containing 30 capsules each month. The first can will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Control group: Along with their medical drugs, such as Mesalazine and Azaram, the placebo oral supplement from Karen pharmaceutical company without any medicinal combination and filled with glycerol, gelatin, and lecithin is taken once daily for 60 days. Patients are given two cans containing 30 capsules each month. The first can will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Clinical symptoms. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Mayo questionnaire. Quality of life. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Inflammatory Bowel Disease Quality of Life Short Questionnaire (IBDQ-9). Serum zinc level. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. C-reactive protein (CRP). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Interleukin 17 (IL-17). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Interleukin 6 (IL-6). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Interleukin 10 (IL-10). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Transforming growth factor beta (TGF-β). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit. Tumor necrosis factor alpha (TNF-α). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Gene expression in PBMC samples. Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Gene expression in PBMC samples. Calprotectin gene expression. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Gene expression in PBMC samples. Toll-like receptor 4 (TLR-4). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Gene expression in PBMC samples. Tehran University of Medical Sciences Approved 2022-11-26 Ethics Committee of Tehran University of Medical Sciences 13th floor, Block A, Treatment and Medical Education, Central Headquarters of the Ministry of Health, Simai Iran St., between South Flamek and Zarafshan, Quds town (west) Tehran Tehran Iran (Islamic Republic of)