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The effect of omega-3 fatty acid plus vitamin E supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients

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History
# Registration date Revision Id
2 2019-09-27, 1398/07/05 109774
1 2014-10-26, 1393/08/04 6058
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of omega-3 fatty acid and vitamin E co-supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Patients aged 18-75 years with Hemodialysis status will be included in this study. Receiving omega-3 fatty acid and vitamin E in 3 months prior to the study, pregnancy (positive β-HCG), liver disease and PTH more than 150 pg/ml will be excluded in the study. Population and sample size: 120 Hemodialysis patients eligible and referred to Akhavan Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be divided into four groups to receive either 1200 mg omega-3/day plus 400 IU vitamin E/day co-supplement (intervention group: n=30), 1200 mg omega-3/day supplement (intervention group: n=30), 400 IU vitamin E/day supplement (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles, inflammatory factors and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (August 1, 2014-November 1, 2014). Outcomes: Fasting plasma glucose, serum triglycerides, cholesterol, HDL-cholesterol, hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA) will be measured at baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب اسید چرب امگا-3 و ویتامین E بر روی پروفایل های متابولیک، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در بیماران همودیالیزی است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: بیماران 75-18 ساله با وضعیت همودیالیز در این مطالعه وارد خواهند شد. دریافت اسید چرب امگا-3 و ویتامین E در سه ماه قبل از مداخله، بارداری (β-HCG مثبت)، بیماری کبدی و میزان پاراتورمون بیشتر از pg/ml 150 از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 120 بیمار همودیالیزی واجد شرایط و ارجاع شده به بیمارستان اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به چهار گروه برای دریافت مکمل ترکیب 1200 میلی گرم امگا-3 روزانه بعلاوه 400 واحد ویتامین E روزانه (گروه مداخله: 30=n)، مکمل 1200 میلی گرم امگا-3 روزانه (گروه مداخله: 30=n)، مکمل 400 واحد ویتامین E روزانه (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته (از 10 مرداد 1393 تا 10 آبان 1393). پيامدها: قند خون ناشتا، تری گلیسرید، کلسترول، کلسترول HDL، hs-CRP سرمی، نیتریک اکساید، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون و مالون دی آلدئید پلاسمایی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of omega-3 fatty acid and vitamin E co-supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب اسید چرب امگا-3 و ویتامین E بر روی پروفایل های متابولیک، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو در بیماران همودیالیزی است.
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    Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 120 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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    ز بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 120 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
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    Inclusion Criteria: Patients aged 18-80 years with Hemodialysis status. Exclusion Criteria: Pregnant, taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment.
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    معیارهای ورود مطالعه: بیماران 80-18 ساله با وضعیت همودیالیز. معیارهای خروج مطالعه: زنان باردار، گرفتن آنتی اکسیدانت یا داروهای سرکوبگر ایمنی طی سه ماه قبل از مداخله.
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    Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally. Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally. Intervention group: Vitamin E pearl, 400 IU, daily, for 12 weeks orally. Control group: Placebo pearl, daily, for 12 weeks orally.
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    گروه مداخله: پرل امگا-3 و پرل ویتامین E، 1250 میلی گرم و 400 واحد، روزانه، به صورت خوراکی برای 12 هفته. گروه مداخله: پرل امگا-3، 1250 میلی گرم، روزانه، به صورت خوراکی برای 12 هفته. گروه مداخله: پرل ویتامین E، 400 واحد، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پرل پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
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    Outcomes: Malondialdehyde and SGA score (primary outcomes), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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    پيامدها: مالون دی آلدئید و امتیاز SGA (پیامدهای اولیه) و گلیسمیک کنترل، پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    75
    80
    1
    1
    1
    Factorial
    Parallel
    N/A
    3
    2014-07-22, 1393/04/31
    2014-08-02, 1393/05/11
    2014-08-01, 1393/05/10
    2014-08-06, 1393/05/15
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    Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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    بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    Patients aged 18-80 years with Hemodialysis status
    بیماران 80-18 ساله با وضعیت همودیالیز
    Pregnant
    Taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment
    زنان باردار
    گرفتن آنتی اکسیدانت یا داروهای سرکوبگر ایمنی طی سه ماه قبل از مداخله
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    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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    empty

  • Primary outcomes

    #1
    Fasting plasma glucose
    SGA score
    قند خون ناشتا
    امتیاز SGA
    Baseline and End-of-trial
    At the beginning of the study and after 12 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Enzymatic
    Calculation
    آنزیمی
    محاسبه
    #2
    Triglycerides
    Malondialdehyde
    تری گلیسرید
    مالون دی آلدئید
    Baseline and End-of-trial
    At the beginning of the study and after 12 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Enzymatic
    Spectrophotometry
    آنزیمی
    اسپکتروفتومتری
    #3
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #4
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #5
    Hs-CRP
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا
    empty
    #6
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #7
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #8
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty

  • Secondary outcomes

    #1
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #2
    empty
    Insulin resistance
    empty
    مقاومت به انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Calculation using HOMA formula
    empty
    محاسبه با استفاده از فرمول HOMA
    #3
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    HDL
    empty
    HDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    LDL
    empty
    LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #7
    empty
    VLDL
    empty
    VLDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #8
    empty
    FPG
    empty
    قند خون ناشتا
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #9
    empty
    Total antioxidant
    empty
    توتال آنتی اکسیدانت
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #10
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #11
    empty
    Nitric oxide
    empty
    نیتریک اکساید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #12
    empty
    Hs-CRP
    empty
    Hs-CRP
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #13
    empty
    Creatinine
    empty
    کراتی نین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #14
    empty
    BUN
    empty
    BUN
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #15
    empty
    Albumin
    empty
    آلبومین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #16
    empty
    TIBC
    empty
    TIBC
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی

  • Intervention groups

    #1
    Intervention group: Omega-3 pearl and vitamin E pearl, 1200 mg and 400 IU, daily, for 12 weeks orally.
    Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally.
    گروه مداخله: پرل امگا-3 و پرل ویتامین E، 1200 میلی گرم و 400 واحد، روزانه، به صورت خوراکی برای 12 هفته.
    گروه مداخله: پرل امگا-3 و پرل ویتامین E، 1250 میلی گرم و 400 واحد، روزانه، به صورت خوراکی برای 12 هفته.
    #2
    Intervention group: Omega-3 pearl, 1200 mg, daily, for 12 weeks orally.
    Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally.
    گروه مداخله: پرل امگا-3، 1200 میلی گرم، روزانه، به صورت خوراکی برای 12 هفته.
    گروه مداخله: پرل امگا-3، 1250 میلی گرم، روزانه، به صورت خوراکی برای 12 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Akhavan Hospital
    Name of recruitment center - Persian: بیمارستان اخوان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English:
    Street address - Persian:
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Akhavan Hospital
    Name of recruitment center - Persian: بیمارستان اخوان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Bolvare Ghotbe Ravandi, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5554 0022
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
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    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutrition PhD
    Position - Persian: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bolvare Ghotbe Ravandi, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutrition PhD
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: rasemi_r@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available.
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of omega-3 fatty acid and vitamin E co-supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients.
Design
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 120 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 18-80 years with Hemodialysis status. Exclusion Criteria: Pregnant, taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment.
Intervention groups
Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally. Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally. Intervention group: Vitamin E pearl, 400 IU, daily, for 12 weeks orally. Control group: Placebo pearl, daily, for 12 weeks orally.
Main outcome variables
Outcomes: Malondialdehyde and SGA score (primary outcomes), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number: IRCT201410245623N28
Registration date: 2014-10-26, 1393/08/04
Registration timing: retrospective

Last update: 2019-11-03, 1398/08/12
Update count: 1
Registration date
2014-10-26, 1393/08/04
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-08-02, 1393/05/11
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid plus vitamin E supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in Hemodialysis patients
Public title
Effect of supplementation in treatment of Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-80 years with Hemodialysis status
Exclusion criteria:
Pregnant Taking antioxidant supplements or immunosuppressive medications within 3 months prior to enrollment
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2014-08-01, 1393/05/10
Ethics committee reference number
P/29/5/1/3538

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
SGA score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation

2

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

Secondary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

3

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

7

Description
VLDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

8

Description
FPG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

9

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

10

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

11

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

12

Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

13

Description
Creatinine
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

14

Description
BUN
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

15

Description
Albumin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

16

Description
TIBC
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Omega-3 pearl and vitamin E pearl, 1250 mg and 400 IU, daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Intervention group: Omega-3 pearl, 1250 mg, daily, for 12 weeks orally.
Category
Treatment - Drugs

3

Description
Intervention group: Vitamin E pearl, 400 IU, daily, for 12 weeks orally.
Category
Treatment - Drugs

4

Description
Control group: Placebo pearl, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhavan Hospital
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0022
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
rasemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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