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
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Protocol summary
Patients with mild-to-moderate active UC will be recruited between 2019-2020 from Rasoul-Akram medical center in Tehran, Iran. All 70 included patients will be randomized to receive 1 capsule a day of placebo or selenium for a duration of 10 wk. Each selenium capsule contained 200 micro gram of selenomethionine. Blood sampling, anthropometric measurements and related questionnaires will be done at baseline and at the end of the study.
Patients with mild-to-moderate active UC will be recruited between 2019-2020 from Rasoul-Akram medical center in Tehran, Iran. All 100 included patients will be randomized to receive 1 capsule a day of placebo or selenium for a duration of 10 wk. Each selenium capsule contained 200 micro gram of selenomethionine. Blood sampling, anthropometric measurements and related questionnaires will be done at baseline and at the end of the study.
Patients with mild-to-moderate active UC will be recruited between 2019-2020 from Rasoul-Akram medical center in Tehran, Iran. All 70100 included patients will be randomized to receive 1 capsule a day of placebo or selenium for a duration of 10 wk. Each selenium capsule contained 200 micro gram of selenomethionine. Blood sampling, anthropometric measurements and related questionnaires will be done at baseline and at the end of the study.
افراد مورد مطالعه بیماران مبتلا به کولیت زخمی با شدت متوسط تا خفیف مراجعه کننده به کلینیک گوارش بیمارستان حضرت رسول اکرم (ص) در سال 1398 خواهند بود، تمام 70 بیمار واجد شرایط بصورت تصادفی به دو گروه دریافت کننده دارونما و یا دریافت کننده سلنیم تقسیم می شوند. هر کپسول سلنیم حای 200 میکروگرم سلنومتیونین می باشد. خون گیری و پرسشنامه های مربوط به اطلاعات افراد و اندازه گیری های انتروپومتریک ابتدا و انتهای مطالعه اخذ می گردد.
افراد مورد مطالعه بیماران مبتلا به کولیت زخمی با شدت خفیف تا متوسط فعال مراجعه کننده به کلینیک گوارش بیمارستان حضرت رسول اکرم (ص) در سال 1398 خواهند بود، تمام 100 بیمار واجد شرایط بصورت تصادفی به دو گروه دریافت کننده دارونما و یا دریافت کننده سلنیم تقسیم می شوند. هر کپسول سلنیم حای 200 میکروگرم سلنومتیونین می باشد. خون گیری و پرسشنامه های مربوط به اطلاعات افراد و اندازه گیری های انتروپومتریک ابتدا و انتهای مطالعه اخذ می گردد.
افراد مورد مطالعه بیماران مبتلا به کولیت زخمی با شدت متوسطخفیف تا خفیفمتوسط فعال مراجعه کننده به کلینیک گوارش بیمارستان حضرت رسول اکرم (ص) در سال 1398 خواهند بود، تمام 70100 بیمار واجد شرایط بصورت تصادفی به دو گروه دریافت کننده دارونما و یا دریافت کننده سلنیم تقسیم می شوند. هر کپسول سلنیم حای 200 میکروگرم سلنومتیونین می باشد. خون گیری و پرسشنامه های مربوط به اطلاعات افراد و اندازه گیری های انتروپومتریک ابتدا و انتهای مطالعه اخذ می گردد.
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score ≤2 [Simple Clinical Colitis Activity Index]
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score [Simple Clinical Colitis Activity Index]
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score ≤2 [Simple Clinical Colitis Activity Index]
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAIکمتر و مساوی2
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAI
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAIکمتر و مساوی2SCCAI
General information
70
100
70100
2020-02-19, 1398/11/30
2020-03-19, 1398/12/29
2020-0203-19 00:00:00
empty
sample size change
sample size change
empty
تغییر در حجم نمونه
تغییر در حجم نمونه
Primary outcomes
#1
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score ≤2
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score ≤2
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAIکمتر و مساوی2
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAI
درصد بیماران با بهبودی علایم براساس پرسشنامه SCCAIکمتر و مساوی2SCCAI
Recruitment centers
#1
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: maryam khazdouz
Full name of responsible person - Persian: مریم خزدوز
Street address - English: Satarkhan St.
Street address - Persian: ستارخان
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6651 5001
Fax:
Email: hrmc@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Maryam Khazdouz
Full name of responsible person - Persian: مریم خزدوز
Street address - English: Satarkhan St.
Street address - Persian: ستارخان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6651 5001
Fax:
Email: hrmc@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Name of recruitment center - Persian: بیمارستان رسول اکرم Full name of responsible person - English: maryam khazdouzMaryam Khazdouz Full name of responsible person - Persian: مریم خزدوز Street address - English: Satarkhan St. Street address - Persian: ستارخان City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6651 5001 Fax: Email: hrmc@iums.ac.ir Web page address:
Protocol summary
Study aim
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
Design
Two arm parallel group randomized double blind trial
Settings and conduct
Patients with mild-to-moderate active UC will be recruited between 2019-2020 from Rasoul-Akram medical center in Tehran, Iran. All 100 included patients will be randomized to receive 1 capsule a day of placebo or selenium for a duration of 10 wk. Each selenium capsule contained 200 micro gram of selenomethionine. Blood sampling, anthropometric measurements and related questionnaires will be done at baseline and at the end of the study.
Participants/Inclusion and exclusion criteria
Patients with age: 18≤ years who have a confirmed endoscopic and histologic diagnosis of UC and active mild-to-moderate UC , 30<BMI ≥18/5 will be recruited. The onset of some diseases, pregnancy or lactation in women, the use of multi-vitamin - Mineral supplements, omega-3, polyphenols and antioxidants, and some drugs (statins), NSAIDs, aspirin and etc during one previous month are excluded criteria of the study.
Intervention groups
200 microgram selenium /day
Main outcome variables
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score [Simple Clinical Colitis Activity Index]
General information
Reason for update
sample size change
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N51
Registration date:2019-03-11, 1397/12/20
Registration timing:prospective
Last update:2020-04-14, 1399/01/26
Update count:1
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Selenium supplementation n patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The Permuted Block randomization method will be used with Six-block blocks
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.688
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
percentage of patients in clinical remission at the end of treatment, defined as SCCAI score
Intervention group: cap selenium 200 microgram 1/d
Category
Treatment - Drugs
2
Description
Control group: Rice flour Cap 1/d
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Maryam Khazdouz
Street address
Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
hrmc@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
shidfar.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor of nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Email
shidfar.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2755
Email
shidfar.f@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The primary outcome is the capable to share at the end of the study
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic institutes
Under which criteria data/document could be used
By requesting the correspond, there will be the possibility of using the data
From where data/document is obtainable
Professor Farzad Shidfar School of Public Health Iran University of Medical Science Hemmat, and Chamran Highways crossroad Tehran Iran. Tel: +98 21 86704743 Cell: +98 9123082922 Fax: +98 21 88622707 Email: shidfar.f@iums.ac.ir Additional email: farzadShidfar@yahoo.com
What processes are involved for a request to access data/document
When, an email sent to the correspond author, the data will usually be sent within 5 to 10 business days