The effect of grape seed extract on the expression of genes mediating immunity, inflammation, disease severity and quality of life in patients with ulcerative colitis
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Protocol summary
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 86 patients with ulcerative colitis
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 66 patients with ulcerative colitis
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 8666 patients with ulcerative colitis
کار ازمایی بالینی،موازی با گروه کنترل،سه سو کور، تصادفی شده، فاز 3 بر روی 86 بیمار مبتلا به کولیت اولسراتیو
کار ازمایی بالینی،موازی با گروه کنترل،سه سو کور، تصادفی شده، فاز 3 بر روی 66 بیمار مبتلا به کولیت اولسراتیو
کار ازمایی بالینی،موازی با گروه کنترل،سه سو کور، تصادفی شده، فاز 3 بر روی 8666 بیمار مبتلا به کولیت اولسراتیو
Inclusion criteria: age 18 to 65 years, BMI between18.5 and 35 kg/m2, Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist ,Patients using only one of the drug groups, such as 5-aminosalicylic acid (Petasa, Mesalazine, or Asacol), as well as the Azathioprine.
Exclusion criteria: Pregnancy and breastfeeding,Taking anticoagulants such as warfarin or heparin, Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.
Inclusion criteria: age 18 to 65 years, BMI between18.5 and 35 kg/m2, Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist ,Patients using one of the drug groups, such as 5-aminosalicylic acid (Petasa, Mesalazine, or Asacol).
Exclusion criteria: Pregnancy and breastfeeding,Taking anticoagulants such as warfarin or heparin, Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.
Inclusion criteria: age 18 to 65 years, BMI between18.5 and 35 kg/m2, Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist ,Patients using only one of the drug groups, such as 5-aminosalicylic acid (Petasa, Mesalazine, or Asacol), as well as the Azathioprine. Exclusion criteria: Pregnancy and breastfeeding,Taking anticoagulants such as warfarin or heparin, Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.
معیارهای ورود به مطالعه سن18 تا 65 سال, bMI بین 18/5 تا 35 کیلوگرم بر متر مربع,
تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش،
بیماران مصرف کننده تنها یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) و همچنین داروی آزاتیوپرین باشند.
معیارهای عدم ورود:حاملگی و شیردهی, مصرف دارو های ضد انعقاد مانند وارفارین یا هپارین
ابتلا به سایر بیماری ها روده ای، بیماری های خود ایمنی ، سرطان، بیماری التهابی و عفونی
معیارهای ورود به مطالعه سن18 تا 65 سال, bMI بین 18/5 تا 35 کیلوگرم بر متر مربع,
تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش،
بیماران مصرف کننده یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) باشند.
معیارهای عدم ورود:حاملگی و شیردهی, مصرف دارو های ضد انعقاد مانند وارفارین یا هپارین
ابتلا به سایر بیماری ها روده ای، بیماری های خود ایمنی ، سرطان، بیماری التهابی و عفونی
معیارهای ورود به مطالعه سن18 تا 65 سال, bMI بین 18/5 تا 35 کیلوگرم بر متر مربع, تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش، بیماران مصرف کننده تنها یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) و همچنین داروی آزاتیوپرین باشند. معیارهای عدم ورود:حاملگی و شیردهی, مصرف دارو های ضد انعقاد مانند وارفارین یا هپارین ابتلا به سایر بیماری ها روده ای، بیماری های خود ایمنی ، سرطان، بیماری التهابی و عفونی
Expression of genes such as T-bet, GATA3, ROR-γt, FOXp,Serum concentrations of IL-17, hs-CRP,Measurement of ESR,IBDQ-9 and SCCAI-Q questionnaires
Expression of genes such as T-bet, GATA3, ROR-γt, FOXp,Serum concentrations of IL-17, hs-CRP,MDA,SOD,TAC, GPX,Measurement of ESR,IBDQ-9 and SCCAI-Q questionnaires
Expression of genes such as T-bet, GATA3, ROR-γt, FOXp,Serum concentrations of IL-17, hs-CRP,MeasurementCRP,MDA,SOD,TAC, GPX,Measurement of ESR,IBDQ-9 and SCCAI-Q questionnaires
Variables (MDA, SOD, TAC, GPX), with the aim of conducting a secondary study entitled "The Effect of Grape Seed Extract on Antioxidant Status in Patients with Ulcerative Colitis," approved with the ethics code R.IUMS.REC.1403.895, were added to the present study. This study will be conducted after the end of the main study on the patients' serum. The sample size of the main study was changed to 66 people due to lack of funding based on citation of evidence (article).
Variables (MDA, SOD, TAC, GPX), with the aim of conducting a secondary study entitled "The Effect of Grape Seed Extract on Antioxidant Status in Patients with Ulcerative Colitis," approved with the ethics code R.IUMS.REC.1403.895, were added to the present study. This study will be conducted after the end of the main study on the patients' serum. The sample size of the main study was changed to 66 people due to lack of funding based on citation of evidence (article).
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متغیرهای (MDA,SOD,TAC, GPX)، با هدف انجام مطالعه ثانویه با عنوان” اثر عصاره هسته انگور بر وضعیت آنتی اکسیدانی در بیماران مبتلا به کولیت اولسراتیو” با کد اخلاق R.IUMS.REC.1403.895 مصوب گردیده است، به مطالعه حاضر اضافه شد.این مطالعه بعد از اتمام مطالعه اصلی بر روی سرم های بیماران انجام خواهد شد. جحم نمونه مطالعه اصلی به علت کمبود بودجه بر اساس استناد به شواهد (مقاله)به 66 نفر تغییر یافت.
متغیرهای (MDA,SOD,TAC, GPX)، با هدف انجام مطالعه ثانویه با عنوان” اثر عصاره هسته انگور بر وضعیت آنتی اکسیدانی در بیماران مبتلا به کولیت اولسراتیو” با کد اخلاق R.IUMS.REC.1403.895 مصوب گردیده است، به مطالعه حاضر اضافه شد.این مطالعه بعد از اتمام مطالعه اصلی بر روی سرم های بیماران انجام خواهد شد. جحم نمونه مطالعه اصلی به علت کمبود بودجه بر اساس استناد به شواهد (مقاله)به 66 نفر تغییر یافت.
BMI of patients between 18.5-35 kg/m2
Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy.
Patients using only one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol), as well as Azathioprine.
BMI of patients between 18.5-35 kg/m2
Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy.
Patients using one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol).
BMI of patients between 18.5-35 kg/m2 Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy. Patients using only one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol), as well as Azathioprine.
BMI بیماران بین 18/5 تا 35 کیلوگرم بر متر مربع
تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش براساس، آزمایشات بیمار، علائم بیمار (پرسشنامه شدت بیماری)، کولونوسکوپی
بیماران مصرف کننده تنها یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) و همچنین داروی آزاتیوپرین باشند.
BMI بیماران بین 18/5 تا 35 کیلوگرم بر متر مربع
تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش براساس، آزمایشات بیمار، علائم بیمار (پرسشنامه شدت بیماری)، کولونوسکوپی
بیماران مصرف کننده یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) باشند.
BMI بیماران بین 18/5 تا 35 کیلوگرم بر متر مربع تشخیص ابتلا به کولیت اولسراتیو در مرحله خفیف تا متوسط توسط متخصص گوارش براساس، آزمایشات بیمار، علائم بیمار (پرسشنامه شدت بیماری)، کولونوسکوپی بیماران مصرف کننده تنها یکی از گروه های دارویی (5-آمینوسالیسیلیک اسید (پتاسا، مزالازین یا آساکول) و همچنین داروی آزاتیوپرین باشند.
Primary outcomes
#1
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Total Antioxidant Capacity
Total Antioxidant Capacity
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ظرفیت تام آنتی اکسیدانی (TAC)
ظرفیت تام آنتی اکسیدانی (TAC)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
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در ابتدای مطالعه و انتهای هفته 12
در ابتدای مطالعه و انتهای هفته 12
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TAC concentration in serum using an ELISA kit
TAC concentration in serum using an ELISA kit
empty
غلظت TAC در سرم با استفاده از کیت الایزا
غلظت TAC در سرم با استفاده از کیت الایزا
#2
empty
Malondialdehyde (MDA)
Malondialdehyde (MDA)
empty
مالون دی آلدئید (MDA)
مالون دی آلدئید (MDA)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
در ابتدای مطالعه و انتهای هفته 12
در ابتدای مطالعه و انتهای هفته 12
empty
MDA concentration in serum using an ELISA kit
MDA concentration in serum using an ELISA kit
empty
غلظت MDA در سرم با استفاده از کیت الایزا
غلظت MDA در سرم با استفاده از کیت الایزا
#3
empty
Superoxide dismutase (SOD)
Superoxide dismutase (SOD)
empty
سوپراکسید دیسموتاز (SOD)
سوپراکسید دیسموتاز (SOD)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
در ابتدای مطالعه و انتهای هفته 12
در ابتدای مطالعه و انتهای هفته 12
empty
SOD concentration in serum using an ELISA kit
SOD concentration in serum using an ELISA kit
empty
غلظت SOD در سرم با استفاده از کیت الایزا
غلظت SOD در سرم با استفاده از کیت الایزا
#4
empty
Glutathione peroxidase (GPX)
Glutathione peroxidase (GPX)
empty
گلوتاتیون پراکسیداز( GPX)
گلوتاتیون پراکسیداز( GPX)
empty
At the beginning of the study and at the end of week 12
At the beginning of the study and at the end of week 12
empty
در ابتدای مطالعه و انتهای هفته 12
در ابتدای مطالعه و انتهای هفته 12
empty
GPX concentration in serum using an ELISA kit
GPX concentration in serum using an ELISA kit
empty
غلظت GPX در سرم با استفاده از کیت الایزا
غلظت GPX در سرم با استفاده از کیت الایزا
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکتر رضا فلک، سرپرست تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Full name of responsible person - Persian: Dr. Reza Falak, Head of Deputy of Research and Technology, Iran University of Medical Sciences
Street address - English: Iran University of Medical Sciences, next to Milad Tower, Hammet Highway
Street address - Persian: تهران، بزرگراه همت، جنب برجمیلاد، دانشگاهعلوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14496-14535
Phone: +98 21 8862 2703
Fax:
Email: rezafalak@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Reza Falak, Head of Deputy of Research and Technology, Iran University of Medical Sciences
Full name of responsible person - Persian: دکتر رضا فلک، سرپرست تحقیقات و فناوری، دانشگاه علوم پزشکی ایران
Street address - English: Iran University of Medical Sciences, next to Milad Tower, Hammet Highway
Street address - Persian: تهران، بزرگراه همت، جنب برجمیلاد، دانشگاهعلوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14496-14535
Phone: +98 21 8862 2703
Fax:
Email: rezafalak@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکتر رضا فلک، سرپرست تحقیقات و فناوری، دانشگاه علوم پزشکی ایران Full name of responsible person - Persian: Dr. Reza Falak, Head of Deputy of Research and Technology, Iran University of Medical Sciences Full name of responsible person - Persian: دکتر رضا فلک، سرپرست تحقیقات و فناوری، دانشگاه علوم پزشکی ایران Street address - English: Iran University of Medical Sciences, next to Milad Tower, Hammet Highway Street address - Persian: تهران، بزرگراه همت، جنب برجمیلاد، دانشگاهعلوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14496-14535 Phone: +98 21 8862 2703 Fax: Email: rezafalak@yahoo.com Web page address:
Protocol summary
Study aim
Determining the effect of grape seed extract on the expression of genes mediating immunity, inflammation, disease severity, and quality of life in patients with ulcerative colitis.
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 66 patients with ulcerative colitis
Settings and conduct
Ulcerative colitis patients referred to Rasoul Akram Hospital, who meet the inclusion criteria, are randomly divided into two groups: the intervention group (receiving grape seed extract) and the placebo control group for 12 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years, BMI between18.5 and 35 kg/m2, Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist ,Patients using one of the drug groups, such as 5-aminosalicylic acid (Petasa, Mesalazine, or Asacol).
Exclusion criteria: Pregnancy and breastfeeding,Taking anticoagulants such as warfarin or heparin, Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.
Expression of genes such as T-bet, GATA3, ROR-γt, FOXp,Serum concentrations of IL-17, hs-CRP,MDA,SOD,TAC, GPX,Measurement of ESR,IBDQ-9 and SCCAI-Q questionnaires
General information
Reason for update
Variables (MDA, SOD, TAC, GPX), with the aim of conducting a secondary study entitled "The Effect of Grape Seed Extract on Antioxidant Status in Patients with Ulcerative Colitis," approved with the ethics code R.IUMS.REC.1403.895, were added to the present study. This study will be conducted after the end of the main study on the patients' serum. The sample size of the main study was changed to 66 people due to lack of funding based on citation of evidence (article).
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009472N28
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2025-05-26, 1404/03/05
Update count:1
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of grape seed extract on the expression of genes mediating immunity, inflammation, disease severity and quality of life in patients with ulcerative colitis
Public title
The effect of grape seed extract in ulcerative colitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
BMI of patients between 18.5-35 kg/m2
Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy.
Patients using one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol).
Exclusion criteria:
Pregnancy and breastfeeding
Taking anticoagulants such as warfarin or heparin
Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
A person outside the study is asked to randomly assign the letter A or B to the cans of supplement and placebo by flipping a coin, and then hand the cans to the researcher. It is used to randomize patients to receive packages A and B using random number generation software.After analyzing the data, the person outside the study will be requested to provide the names of the drug and placebo labels to be utilized in the results and discussion section.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Supplement and placebo will be categorized based on random codes. The researcher, gastroenterologist, individuals involved in sample evaluation, and the person conducting statistical analysis will be blinded to the intervention or control group assignment.
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
Research and Technology Vice-Chancellor, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.IUMS.REC.1402.451
Health conditions studied
1
Description of health condition studied
Patients with ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
T-bet gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR
2
Description
GATA3 gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR
3
Description
ROR-ꝩtgene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR
4
Description
FOXp3 gene expression
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Real-time PCR
5
Description
Serum concentration of hs-CRP
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Eliza
6
Description
Serum concentration of IL-17
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Eliza
7
Description
ESR
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
westergren
8
Description
Disease Severity(SCCAI-Q)
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Severity of Disease Questionnaire (SCCAI-Q)
9
Description
Quality of Life(IBDQ-9)
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Quality of life questionnaire(IBDQ-9)
10
Description
Total Antioxidant Capacity
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
TAC concentration in serum using an ELISA kit
11
Description
Malondialdehyde (MDA)
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
MDA concentration in serum using an ELISA kit
12
Description
Superoxide dismutase (SOD)
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
SOD concentration in serum using an ELISA kit
13
Description
Glutathione peroxidase (GPX)
Timepoint
At the beginning of the study and at the end of week 12
Method of measurement
GPX concentration in serum using an ELISA kit
Secondary outcomes
1
Description
BMI
Timepoint
At the beginning of the study and the twelfth week
Method of measurement
Weight(kg)/ (height)m²
Intervention groups
1
Description
Intervention group: Patients will receive 600 mg/day (two tablets of 300 mg) of grape seed extract, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks.
Category
Treatment - Drugs
2
Description
Control group:Patients will receive 600 mg/day (two tablets of 300 mg) of placebo, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital, Tehran
Full name of responsible person
Elham Pishgar
Street address
Niyayesh St., Satarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
dr.elhampishgar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak, Head of Deputy of Research and Technology, Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hammet Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8862 2703
Email
rezafalak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Dr. Nahid Aryaeian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, , School of Public Health
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
aryaeian.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Aryaeian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Fax
Email
aryaeian.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Aryaeian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Public Health,Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
aryaeian.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable personal data of participants; Only part of the data such as the original outcome information
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
To conduct studies
From where data/document is obtainable
Dr. Nahid Aryaeian : aryaeian.n@iums.ac.ir
What processes are involved for a request to access data/document
Request by e-mail along with providing a complete explanation of why the data is needed