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IRCT20091114002709N51 IRCT 2019-03-11 Iran University of Medical Sciences The effect of Selenium supplementation n patients with ulcerative colitis The effect of Selenium supplementation on remission rate, serum levels of Interleukins 10, 17 and SIRT1 and PGC-1a gene expression and Quality of Life in patients with ulcerative colitis: Double-Blind RCT 2019-04-06 anticipated 100 Complete https://irct.ir/trial/35701 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Permuted Block randomization method will be used with Six-block blocks, Blinding description: In order to concealment in the randomization, unique codes will be used on the drug boxes, the code being generated by the software. 3 Ulcerative colitis. Intervention 1: Intervention group: cap selenium 200 microgram 1/d. Intervention 2: Control group: Rice flour Cap 1/d. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Farzad Shidfar
Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2503 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Volunteering participation in the study The definitive diagnosis of injured colitis by using histological methods on mucosal biopsy of the colon, rectum and jejunium by the physician in the mild to moderate phase The consumer of only one of the 5-amino-salicylic acid Pentasa, mesalazine or asacole), as well as an immunomodulatory drug such as azathioprine (maximum one tablet/d) age: 18≤ 30<BMI ≥18/5 18 years no limit Both Change in the type and dosage of the drug during the past month The onset of some diseases such as : autoimmune diseases, cancer, inflammatory and infectious diseases) Pregnancy or lactation in women or the use of contraceptives The use of multi-vitamin - Mineral supplements, omega-3, polyphenols and antioxidants during one previous month The use of cholesterol lowering drugs (statins), NSAIDs, aspirin and diclofenac, antihistamines, anticoagulants, anti-TNF drugs, barbiturates, corticosteroids) during one previous month K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: cap selenium 200 microgram 1/d Control group: Rice flour Cap 1/d Percentage of patients in clinical remission at the end of treatment, defined as SCCAI score. Timepoint: at baseline and end of study. Method of measurement: [Simple Clinical Colitis Activity Index] Questionnaire. Quality of life. Timepoint: at first and end of study. Method of measurement: IBDQ- 9 questionnaire. Interleukin 17. Timepoint: at baseline and end of study. Method of measurement: ELISA kit. Interleukin 10. Timepoint: at baseline and end of study. Method of measurement: ELISA kit. PGC1-α gene expression. Timepoint: at baseline and end of study. Method of measurement: Real Time RT-PCR. Sirt1 gene expression. Timepoint: at baseline and end of study. Method of measurement: Real Time RT-PCR. Iran University of Medical Sciences Approved 2018-10-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway tehran Tehran Iran (Islamic Republic of)