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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20091114002709N51
Enrollment
100
Registered
2019-03-11
Start date
2019-04-06
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: cap selenium 200 microgram 1/d. Intervention 2: Control group: Rice flour Cap 1/d.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Shidfar

Iran University of Medical Sciences

shidfar.f@iums.ac.ir+98 21 8670 2503

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026