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IRCT20190712044182N3 IRCT 2022-09-18 Iran University of Medical Sciences "zinc supplementation"; "Ulcerative colitis" zinc supplementation in patients with ulcerative colitis: effects on clinical symptoms, and inflammatory/anti-inflammatory cytokines affecting the immune system 2022-09-23 anticipated 50 Complete https://irct.ir/trial/65220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the patients, people are randomly assigned to two groups receiving a zinc gluconate supplement and a placebo. For randomization, permuted block randomization with 4 blocks and 2 blocks (based on age and BMI) will be used. The randomization unit 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 person evaluating the patient (interrogator) and the attending physician will not be aware of the intervention, Blinding description: In order to apply concealment (double-blind) 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 sealed envelope method. As each person enters the study based on the generated sequence, the supplementary package in which the desired code is recorded will be allocated to the person, and therefore, before choosing the person, no one will be not aware of the type of treatment he will receive. Also, the person evaluating the patient and the attending physician will not be aware of the intervention. 3 ulcerative colitis disease. Intervention 1: Intervention group: Patients take one daily zinc gluconate softgel from Dana Pharmaceutical Company with 40 mg of elemental zinc and capsule filler (glycerol, gelatin, and lecithin) along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle 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: Patients take one daily placebo from Dana Pharmaceutical Company without any drug Compounds including zinc and a capsule filled with glycerol, gelatin, and lecithin along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle 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 Correspondent masoomehkhalighi@gmail.com How to obtain: They can request information and documents by email Comments:
public Mohsen Masoodi
Sattar Khan Street, Maziar Mansouri Street, Rasool Akram Hospital
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 masoodi47@yahoo.com Iran University of Medical Sciences scientific Gholamreza Mohammadi Farsani
No. 44, Hojat Dost St., Naderi St., Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8895 5975 mohammadigh53@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Body mass index between 18.5 and 35 ِDiagnosis of ulcerative colitis according to the patient's symptoms, tests and colonoscopy, and intestinal sample pathology Mild to moderate active form of the disease according to the Mayo questionnaire Absence of concomitant diseases not taking supplements containing zinc during the last 2 months No use of infliximab, Sinora, high dose of corticosteroids (above 40 mg), NSAIDs Not pregnant or lactating Not taking contraceptives 18 years 50 years Both K51.9 Ulcerative colitis, unspecified Treatment - Drugs Placebo Intervention group: Patients take one daily zinc gluconate softgel from Dana Pharmaceutical Company with 40 mg of elemental zinc and capsule filler (glycerol, gelatin, and lecithin) along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Control group: Patients take one daily placebo from Dana Pharmaceutical Company without any drug Compounds including zinc and a capsule filled with glycerol, gelatin, and lecithin along with their therapeutic medications, including Mesalazine and Azaram, for 60 days. Capsules are given to patients in two bottles containing 30 softgel in each of them. The first bottle will be delivered to the patient on the day of sampling and instructions will be given on how to use it. Severity of clinical symptoms. Timepoint: At the baseline (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. Serum level of Interlukin-6. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit. Serum level of Interlukin-17. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit. Serum level of TNF-α. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit. Quality of life. Timepoint: At the baseline (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 level of Interlukin-10. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit. Iran University of Medical Sciences Approved 2022-04-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)