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The effect of Selenium supplementation n patients with ulcerative colitis

Phase 3
Conditions
lcerative colitis.
Ulcerative colitis
Registration Number
IRCT20091114002709N51
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
100
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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-a 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.
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