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Protocol summary
Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) on lipid profile, and sestrin 2 and Nrf2 factor gene expression in patients with type 2 diabetes
Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on lipid profile, and sestrin 2 and Nrf2 gene expression in patients with type 2 diabetes
Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) on lipid profile, and sestrin 2 and Nrf2 factor gene expression in patients with type 2 diabetes
80 patients with type 2 diabetes considering inclusion and exclusion criteria are divided into 2 groups of drug and placebo. The patients will be allocated randomly to either groups using permuted block randomization. Codes will be assigned to patients for concealment.
70 patients with type 2 diabetes are divided into 2 groups of drug and placebo. The patients will be allocated randomly to either groups using permuted block randomization. Codes will be assigned to patients for concealment.
8070 patients with type 2 diabetes considering inclusion and exclusion criteria are divided into 2 groups of drug and placebo. The patients will be allocated randomly to either groups using permuted block randomization. Codes will be assigned to patients for concealment.
80 نفر بیمار مبتلا به دیابت 2 با در نظر گرفتن معیارهای ورود و خروج و به دو گروه دارو و دارونما تقسیم می شوند. تخصیص به دو گروه به صورت تصادفی به روش permuted block randomization خواهد بود. برای پنهان سازی گروه مداخله به هریک از شرکت کنندگان یک کد تخصیص داده خواهد شد. مطالعه به صورت دو سوکور انجام خواهد شد.
70 بیمار مبتلا به دیابت 2 به دو گروه دارو و دارونما تقسیم می شوند. تصادفی سازی به روش permuted block randomization خواهد بود. برای پنهان سازی گروه مداخله به هریک از شرکت کنندگان یک کد تخصیص داده خواهد شد.
80 نفر70 بیمار مبتلا به دیابت 2 با در نظر گرفتن معیارهای ورود و خروج و به دو گروه دارو و دارونما تقسیم می شوند. تخصیص به دو گروه به صورت تصادفی سازی به روش permuted block randomization خواهد بود. برای پنهان سازی گروه مداخله به هریک از شرکت کنندگان یک کد تخصیص داده خواهد شد. مطالعه به صورت دو سوکور انجام خواهد شد.
This randomized double blind clinical trial is performed on 80 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. The study is designed as double blind trial and neither the patients not the physician are aware of the type of supplement that is administered. The clinical details of all the study subjects are recorded.
In the beginning of the study fasting blood samples are collected and used for the measurement of insulin , blood glucose, lipid profile. After the initial clinical and biochemical investigations all the diabetic patients are given either 2700 mg ω-3 fatty acids supplement in the form of oral capsules including EPA (1800 mg) and DHA (900 mg) per day or oral paraffin as the placebo in three divided doses for ten weeks. Blood samples are collected and all the above biochemical parameters including insulin, sestrin and NRF-2 gene expression and total antioxidant levels are meassured 10 weeks after intervention with omega 3 supplements.
Before and after intervention diet input, physical activity level, anthropometric characteristics, systolic and diastolic blood pressure are measured.
This randomized double blind clinical trial is performed on 70 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. Neither the patients nor the physician are aware of the type of supplement that is administered.
In the beginning of the study fasting blood samples are collected and used for the measurement of insulin , blood glucose, lipid profile. After the initial clinical and biochemical investigations all the patients are given either 2700 mg n3PUFA in the form of oral capsules or oral paraffin as the placebo in three divided doses for ten weeks. Blood samples are collected and all the above biochemical parameters including insulin, sestrin and NRF-2 gene expression and total antioxidant levels are measured.
Before and after intervention diet input, anthropometric characteristics, systolic and diastolic blood pressure are measured.
This randomized double blind clinical trial is performed on 8070 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. The study is designed as double blind trial and neitherNeither the patients notnor the physician are aware of the type of supplement that is administered. The clinical details of all the study subjects are recorded. In the beginning of the study fasting blood samples are collected and used for the measurement of insulin , blood glucose, lipid profile. After the initial clinical and biochemical investigations all the diabetic patients are given either 2700 mg ω-3 fatty acids supplementn3PUFA in the form of oral capsules including EPA (1800 mg) and DHA (900 mg) per day or oral paraffin as the placebo in three divided doses for ten weeks. Blood samples are collected and all the above biochemical parameters including insulin, sestrin and NRF-2 gene expression and total antioxidant levels are meassured 10 weeks after intervention with omega 3 supplementsmeasured. Before and after intervention diet input, physical activity level, anthropometric characteristics, systolic and diastolic blood pressure are measured.
این کارآزمایی بالینی تصادفی دو سو کور کنترل شده بر روی 80 بیمار مبتلا به دیابت نوع 2 مراجعه کننده به کلینیک دیابت دانشگاه علوم پزشکی تهران انجام می شود. مطالعه به صورت دو سوکور انجام می شود و نه بیماران و نه پزشک هیچیک از نوع مکمل تجویز شده مطلع نیستند. اطلاعات بالینی بیماران ثبت می گردد. در ابتدای آزمایش نمونه های خون ناشتای بیماران جهت اندازه گیری انسولین ، قند خون ناشتا و پروفایل لیپید آزمایش می شود. بعد از انجام آزمایشات بالینی و بیوشیمیایی اولیه شرکت کنندگان ملزم به رعایت رژیم مصرف مکمل n-3 PUFA به صورت کپسول خوراکی ميزان 2700 میلی گرم (مخلوط EPA=1800mg وDHA=900 mg ) و یا دارونما (پارافین خوراکی) به مدت 10 هفته می شوند. نمونه خون ناشتا جهت اندازه گیری فاکتور های یاد شده و نیز انسولین ، میزان بیان ژن سسترین 2 و فاکتور رونویسی Nrf2 و سطح آنتی اکسیدان توتال پس از ده هفته درمان با مکمل های اومگا-3 از بیماران گرفته می شود.
قبل و بعد از دوره مداخله، دریافت های رژیمی، سطح فعالیت بدنی، شاخص های تن سنجی، فشار خون سیستولیک و فشار خون دیاستولیک اندازه گیری می گردد.
این کارآزمایی بالینی تصادفی دو سو کور کنترل شده بر روی 70 بیمار مبتلا به دیابت نوع 2 مراجعه کننده به کلینیک دیابت دانشگاه علوم پزشکی تهران انجام می شود. در این مطالعه نه بیماران و نه پزشک هیچیک از نوع مکمل تجویز شده مطلع نیستند. اطلاعات بالینی بیماران ثبت می گردد. در ابتدای آزمایش نمونه های خون ناشتای بیماران جهت اندازه گیری انسولین ، قند خون ناشتا و پروفایل لیپید آزمایش می شود. بعد از انجام آزمایشات بالینی و بیوشیمیایی اولیه شرکت کنندگان ملزم به رعایت رژیم مصرف مکمل n-3 PUFA به صورت کپسول خوراکی ميزان 2700 میلی گرم و یا دارونما (پارافین خوراکی) به مدت 10 هفته می شوند. نمونه خون ناشتا جهت اندازه گیری فاکتور های یاد شده و نیز انسولین ، میزان بیان ژن سسترین 2 و فاکتور رونویسی Nrf2 و سطح آنتی اکسیدان توتال پس از ده هفته درمان با مکمل های اومگا-3 از بیماران گرفته می شود.
قبل و بعد از دوره مداخله، دریافت های رژیمی، سطح فعالیت بدنی، شاخص های تن سنجی، فشار خون سیستولیک و فشار خون دیاستولیک اندازه گیری می گردد.
این کارآزمایی بالینی تصادفی دو سو کور کنترل شده بر روی 8070 بیمار مبتلا به دیابت نوع 2 مراجعه کننده به کلینیک دیابت دانشگاه علوم پزشکی تهران انجام می شود. در این مطالعه به صورت دو سوکور انجام می شود و نه بیماران و نه پزشک هیچیک از نوع مکمل تجویز شده مطلع نیستند. اطلاعات بالینی بیماران ثبت می گردد. در ابتدای آزمایش نمونه های خون ناشتای بیماران جهت اندازه گیری انسولین ، قند خون ناشتا و پروفایل لیپید آزمایش می شود. بعد از انجام آزمایشات بالینی و بیوشیمیایی اولیه شرکت کنندگان ملزم به رعایت رژیم مصرف مکمل n-3 PUFA به صورت کپسول خوراکی ميزان 2700 میلی گرم (مخلوط EPA=1800mg وDHA=900 mg ) و یا دارونما (پارافین خوراکی) به مدت 10 هفته می شوند. نمونه خون ناشتا جهت اندازه گیری فاکتور های یاد شده و نیز انسولین ، میزان بیان ژن سسترین 2 و فاکتور رونویسی Nrf2 و سطح آنتی اکسیدان توتال پس از ده هفته درمان با مکمل های اومگا-3 از بیماران گرفته می شود. قبل و بعد از دوره مداخله، دریافت های رژیمی، سطح فعالیت بدنی، شاخص های تن سنجی، فشار خون سیستولیک و فشار خون دیاستولیک اندازه گیری می گردد.
Drug group: treatment with n-3 PUFA supplement with the dose of 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks
Placebo group: treatment with oral paraffin for 10 weeks.
Drug group: treatment with n-3PUFA supplement, 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks
Placebo group: treatment with oral paraffin for 10 weeks.
Drug group: treatment with n-3 PUFA3PUFA supplement with the dose of, 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks Placebo group: treatment with oral paraffin for 10 weeks.
General information
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2018-03-01, 1396/12/10
2018-03-01 00:00:00
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Based on the calculations of sample size, the sample size that is stated in the "randomization section" (70 participants) is correct and the sample size 80 was entered mistakenly and must be corrected.
Based on the calculations of sample size, the sample size that is stated in the "randomization section" (70 participants) is correct and the sample size 80 was entered mistakenly and must be corrected.
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حجم نمونه ای که در تصادفی سازی وارد شده (70 نفر) که بر اساس محاسبات حجم نمونه می باشد، صحیح است ولی حجم نمونه 80 نفر که در قسمت مربوطه وارد شده اشتباه می باشد و نیاز به اصلاح دارد.
حجم نمونه ای که در تصادفی سازی وارد شده (70 نفر) که بر اساس محاسبات حجم نمونه می باشد، صحیح است ولی حجم نمونه 80 نفر که در قسمت مربوطه وارد شده اشتباه می باشد و نیاز به اصلاح دارد.
The effect of Omega 3 supplementation on oxidative stress in diabetic patient type 2
The effect of Omega 3 supplementation on oxidative stress in patients with type 2 diabetes
The effect of Omega 3 supplementation on oxidative stress in diabetic patientpatients with type 2 diabetes
Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 80, 20 blocks of 4 will be produced using www.sealedenvelope.com. In order to perform concealment, unique codes, produced by software, will be assigned to each participant and sealed pockets will be used so that no one is informed about the type of intervention prior to selection.
Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 70, 18 blocks of 4 will be produced using www.sealedenvelope.com. In order to perform concealment, unique codes, produced by software, will be assigned to each participant will be used so that no one is informed about the type of intervention prior to selection.
Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 8070, 2018 blocks of 4 will be produced using www.sealedenvelope.com. In order to perform concealment, unique codes, produced by software, will be assigned to each participant and sealed pockets will be used so that no one is informed about the type of intervention prior to selection.
برای اعمال تصادفی سازی از روش بلوکهای تصادفی (permuted block randomization) با بلوکهای چهارتایی استفاده خواهد شد. با توجه به حجم نمونه 70 تایی که تعیین شده است، 18 بلوک چهارتایی با استفاده از سایت آنلاین (www.sealedenvelope.com) تولید خواهد شد. به منظور اعمال concealment در فرآیند تصادفی سازی از کدهای منحصر به فرد برای هر نمونه استفاده خواهد شد که کد مورد نظر نیز توسط نرم افزار تولید می شود و همچنین از پاکتهای مهر و موم شده استفاده خواهد شد لذا قبل از انتخاب فرد، کسی از نوع درمانی که وی دریافت خواهد کرد، آگاه نخواهد بود.
برای اعمال تصادفی سازی از روش بلوکهای تصادفی (permuted block randomization) با بلوکهای چهارتایی استفاده خواهد شد. با توجه به حجم نمونه 70 تایی که تعیین شده است، 18 بلوک چهارتایی با استفاده از سایت آنلاین (www.sealedenvelope.com) تولید خواهد شد. به منظور اعمال concealment در فرآیند تصادفی سازی از کدهای منحصر به فرد برای هر نمونه استفاده خواهد شد که کد مورد نظر نیز توسط نرم افزار تولید می شود لذا قبل از انتخاب فرد، کسی از نوع درمانی که وی دریافت خواهد کرد، آگاه نخواهد بود.
برای اعمال تصادفی سازی از روش بلوکهای تصادفی (permuted block randomization) با بلوکهای چهارتایی استفاده خواهد شد. با توجه به حجم نمونه 70 تایی که تعیین شده است، 18 بلوک چهارتایی با استفاده از سایت آنلاین (www.sealedenvelope.com) تولید خواهد شد. به منظور اعمال concealment در فرآیند تصادفی سازی از کدهای منحصر به فرد برای هر نمونه استفاده خواهد شد که کد مورد نظر نیز توسط نرم افزار تولید می شود و همچنین از پاکتهای مهر و موم شده استفاده خواهد شد لذا قبل از انتخاب فرد، کسی از نوع درمانی که وی دریافت خواهد کرد، آگاه نخواهد بود.
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Primary outcomes
#1
sestrin expression
Sestrin gene expression
sestrinSestrin gene expression
Secondary outcomes
#1
weight
Weight
weightWeight
kg-scale
Scale
kg-scaleScale
کیلوگرم - ترازو
ترازو
کیلوگرم - ترازو
#2
kg/m2 - calculation according to weight and height
Calculation according to weight and height using relevant formula
kg/m2 - calculationCalculation according to weight and height using relevant formula
کیلوگرم بر متر مربع - محاسبه بر اساس قد و وزن
محاسبه بر اساس قد و وزن و با کمک فرمول
کیلوگرم بر متر مربع - محاسبه بر اساس قد و وزن و با کمک فرمول
#3
insulin
Insulin
insulinInsulin
IU/mlm -elisa
ELISA test
IU/mlm -elisaELISA test
IU/mlµ - الایزا
تست الایزا
IU/mlµ -تست الایزا
#4
empty
Malondialdehyde
Malondialdehyde
empty
مالون دی آلدهید
مالون دی آلدهید
empty
10 weeks
10 weeks
empty
10 هفته
10 هفته
empty
colorimetry
colorimetry
empty
رنگ سنجی
رنگ سنجی
#5
empty
Fasting blood glucose
Fasting blood glucose
empty
قند خون ناشتا
قند خون ناشتا
empty
10 weeks
10 weeks
empty
10 هفته
10 هفته
empty
colorimetry
colorimetry
empty
رنگ سنجی
رنگ سنجی
#6
empty
HOMA-IR
HOMA-IR
empty
HOMA-IR
HOMA-IR
empty
10 weeks
10 weeks
empty
10 هفته
10 هفته
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calculation
calculation
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محاسبه
محاسبه
Protocol summary
Study aim
Evaluation of the effect of Omega 3 supplementation (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on lipid profile, and sestrin 2 and Nrf2 gene expression in patients with type 2 diabetes
Design
70 patients with type 2 diabetes are divided into 2 groups of drug and placebo. The patients will be allocated randomly to either groups using permuted block randomization. Codes will be assigned to patients for concealment.
Settings and conduct
This randomized double blind clinical trial is performed on 70 patients with type 2 diabetes admitted to Diabetes Clinic of Tehran University of Medical Sciences. Neither the patients nor the physician are aware of the type of supplement that is administered.
In the beginning of the study fasting blood samples are collected and used for the measurement of insulin , blood glucose, lipid profile. After the initial clinical and biochemical investigations all the patients are given either 2700 mg n3PUFA in the form of oral capsules or oral paraffin as the placebo in three divided doses for ten weeks. Blood samples are collected and all the above biochemical parameters including insulin, sestrin and NRF-2 gene expression and total antioxidant levels are measured.
Before and after intervention diet input, anthropometric characteristics, systolic and diastolic blood pressure are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having type 2 diabetes, BMI within 25-40 kg/m2 range, men 30-65 yr , women 30 yr-before menopause
Exclusion criteria: having other diseases, taking drugs which may affect obesity or metabolism, pregnancy and lactation.
Intervention groups
Drug group: treatment with n-3PUFA supplement, 2700 mg (combination of EPA=1800 mg and DHA=900 mg) for 10 weeks
Placebo group: treatment with oral paraffin for 10 weeks.
Based on the calculations of sample size, the sample size that is stated in the "randomization section" (70 participants) is correct and the sample size 80 was entered mistakenly and must be corrected.
Acronym
IRCT registration information
IRCT registration number:IRCT20150926024198N4
Registration date:2018-01-28, 1396/11/08
Registration timing:retrospective
Last update:2020-01-30, 1398/11/10
Update count:1
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Mitra Nourbakhsh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 3109
Email address
nourbakhsh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
2015-08-22, 1394/05/31
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
2018-03-01, 1396/12/10
Scientific title
The effect of Omega 3 supplementation on oxidative stress & the gene expression of sestrin 2 enzyme & Nrf2 factor in diabetic patient type 2
Public title
The effect of Omega 3 supplementation on oxidative stress in patients with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with diabetes duration more than one year.
Diabetic patient in both genders, men 36-65 years old and women from 30 years old upto before menopause.
BMI in the range of 25-40 kg/m2.
Literateness (for recording 3-day meal)
Willingness to maintain weight during the study.
Willingness to maintain routine activities and current lifestyle during the study.
Willingness to participate in the study
Exclusion criteria:
pregnancy and lactation
Consumption of omega-3 supplement in the last three months.
having chronic renal, hepatic, enteric, haematic disorders, microalbuminuria, retinopathy, neuropathy, hypo/hyperthyroidism, cardiac disease, type 1 diabetes according to patient declaration and medical history.
Treatmetn with orlistat, cybotramin, insulin, thiazolidinediones, non-steroidical anti-inflammatory drugs
Using Combined oral contraceptive pills
Using dietary supplements, vitamin supplements, and herbal supplements at least 2 weeks before intervention
Changing dose or type of anti-diabetic drug
Occurrence of any inflammatory disease which requires using anti-inflammation drugs.
Unwillingness to continue participation.
Using less than 90 percent of the omega 3 supplement.
Appearance of any allergic reactions to omega-3.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by permuted block randomization method using block of size 4. according to sample size which is 70, 18 blocks of 4 will be produced using www.sealedenvelope.com. In order to perform concealment, unique codes, produced by software, will be assigned to each participant will be used so that no one is informed about the type of intervention prior to selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the patients are blinded. The placebo has been provided in a form similar to the main drug and each one is indicated by a code that only the main investigator is aware of. The patients do not know whether they are using the main drug or the placebo. The physician who is responsible for physical examination of the patient and administering the supplement is also blinded and not aware of the codes and only delivers the supplements to the patients. Data analyzer is also blinded and analyzes the data according to two separate groups.
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
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.IUMS.REC 1396.1213
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Sestrin gene expression
Timepoint
10 weeks
Method of measurement
Real time- polymerase chain reaction (PCR)
2
Description
NRF2 transcription factor gene expression
Timepoint
10 week
Method of measurement
Real-time PCR
3
Description
Serum total antioxidants
Timepoint
10 weeks
Method of measurement
spectrophotometry
Secondary outcomes
1
Description
Weight
Timepoint
10 weeks
Method of measurement
Scale
2
Description
BMI
Timepoint
10 weeks
Method of measurement
Calculation according to weight and height using relevant formula
3
Description
Insulin
Timepoint
10 weeks
Method of measurement
ELISA test
4
Description
A1C hemoglobin
Timepoint
10 weeks
Method of measurement
spectrophotometry
5
Description
Malondialdehyde
Timepoint
10 weeks
Method of measurement
colorimetry
6
Description
Fasting blood glucose
Timepoint
10 weeks
Method of measurement
colorimetry
7
Description
HOMA-IR
Timepoint
10 weeks
Method of measurement
calculation
Intervention groups
1
Description
Intervention with omega 3 polyunsaturated fatty acid supplement by the daily dose of 1250 mg (combination of EPA=600 mg and DHA= 300 mg) for 10 weeks.
Category
Treatment - Drugs
2
Description
Control group: oral paraffin for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Mazaherion
Street address
North Kargar, Shahrivar st.
City
tehran
Province
Tehran
Postal code
1411715851
Phone
+98 21 8833 4192
Email
maryammazaherioon@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8862 2742
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
96-02-30-31213
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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mazaherioon
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No162, between vatan poor and aghaee Ave,West Farmanieh
City
Tehran
Province
Tehran
Postal code
1984614456
Phone
+98 21 2665 7890
Email
maryammazaherioon@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
Assistant profesoor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry Department, Faculty of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 3109
Fax
+98 21 8862 2742
Email
nourbakhsh.m@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry department, Faculty of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 3109
Fax
+98 21 8862 2742
Email
nourbakhsh.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
All collected deidentified results from primary and secondary outcomes
When the data will become available and for how long
After publication of results
To whom data/document is available
Researchers from academic that applies
Under which criteria data/document could be used
For systematic analysis
From where data/document is obtainable
Contacting the person responsible for scientific enquieries
What processes are involved for a request to access data/document