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Effect of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes

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History
# Registration date Revision Id
3 2019-09-27, 1398/07/05 108892
2 2014-07-16, 1393/04/25 6050
1
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 54 patients with GDM among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 supplements (intervention group: n=27) or placebo (control group: n=27). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles, inflammatory factors and biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 4 months (May 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum hs-CRP levels, nitric oxide, plasma total antioxidant capacity (TAC), total glutathione (GSH) and malondialdehyde (MDA). Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر روی فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و پیامدهای بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آن هایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 54 زن باردار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 (گروه مداخله: 27n=) یا پلاسبو (گروه کنترل27n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک، فاکتورهای التهابی و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. اگرچه مدت مداخله 6 هفته خواهد بود، ولی بیماران تا زمان زایمان پیگیری خواهند شد. زمان مداخله: 4 ماه (از 20 اردیبهشت 1393 تا 20 شهریور 1393). پيامدها: گلوکز پلاسمایی ناشتا، hs-CRP، نیتریک اکساید، ظرفیت آنتی اکسیدانی توتال، گلوتاتیون توتال و مالون دی آلدئید پلاسما در ابتدا و انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بر روی فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و پیامدهای بارداری در دیابت بارداری است.
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    Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Population and sample size: Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 54 patients will be selected according to inclusion and exclusion criteria.
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    حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 54 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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    Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation. Exclusion Criteria: Pre-existing diabetes, required complex diets, chronic medical conditions, significant psychiatric disease, smokers, kidney or liver diseases, chronic hypertension, hypothyroidism.
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    معیارهای ورود مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری. معیارهای خروج مطالعه: داشتن دیابت از قبل، نیاز به رژیم های کمپلکس، شرایط پزشکی مزمن، بیماری روانی بالقوه، سیگاری ها، بیماری های کلیوی یا کبدی، فشار خون مزمن، کم کاری تیروئید.
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    Intervention group: Omega-3 pearl, 1000 mg, daily, for 6 weeks orally. Control group: Placebo pearl, daily, for 6 weeks orally.
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    گروه مداخله: پرل امگا-3، 1000 میلی گرم، روزانه، به صورت خوراکی برای 6 هفته. گروه کنترل: پرل پلاسبو، روزانه، به صورت خوراکی برای 6 هفته.
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    Outcomes: Pregnancy outcomes (primary outcomes),hs-CRP, total nitrite and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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    پيامدها: پیامد بارداری (پیامدهای اولیه)، پروتئین واکنشگر C با حساسیت بالا، توتال نیتریت و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    1
    1
    1
    2014-06-10, 1393/03/20
    2014-05-28, 1393/03/07
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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.
    Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation
    زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
    Pre-existing diabetes
    Required complex diets
    Chronic medical conditions
    Significant psychiatric disease
    Smokers
    Kidney or liver diseases
    Chronic hypertension
    Hypothyroidism
    داشتن دیابت از قبل
    نیاز به رژیم های کمپلکس
    شرایط پزشکی مزمن
    بیماری روانی بالقوه
    سیگاری ها
    بیماری های کلیوی یا کبدی
    فشار خون مزمن
    کم کاری تیروئید
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    Randomization will be done by the use of computer-generated random numbers.
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    تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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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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  • Primary outcomes

    #1
    hs-CRP
    Infants' weight
    پروتئین واکنشگر C با حساسیت بالا
    وزن نوزادان
    Baseline and End-of-trial
    Delivery time
    ابتدا و انتهای مطالعه
    زمان زایمان
    Eliza
    Scale
    الایزا
    ترازو
    #2
    Nitric oxide
    Infants' head circumference
    نیتریک اکساید
    دور سر نوزادان
    Baseline and End-of-trial
    Delivery time
    ابتدا و انتهای مطالعه
    زمان زایمان
    Spectrophotometry
    Tape
    اسپکتروفتومتری
    متر نواری
    #3
    Total antioxidant capacity
    Newborns' length
    ظرفیت آنتی اکسیدانی توتال
    قد نوزادان تازه متولد شده
    Baseline and End-of-trial
    Delivery time
    ابتدا و انتهای مطالعه
    زمان زایمان
    Spectrophotometry
    Tape
    اسپکتروفتومتری
    متر نواری
    #4
    Glutathione
    Polyhydramnios
    گلوتاتیون
    پلی هیدروآمونیوس
    Baseline and End-of-trial
    After the intervention
    ابتدا و انتهای مطالعه
    بعد از مداخله
    Spectrophotometry
    Sonography
    اسپکتروفتومتری
    سونوگرافی
    #5
    Malondialdehyde
    Newborn's bilirubin
    مالون دی آلدئید
    بیلی روبین نوزادان تازه متولد شده
    Baseline and End-of-trial
    Delivery time
    ابتدا و انتهای مطالعه
    زمان زایمان
    Spectrophotometry
    Enzymatic kit
    اسپکتروفتومتری
    کیت آنزیمی
    #6
    Infants' weight
    Apgar score
    وزن نوزادان
    عدد آپگار
    Scale
    Clinical observation
    ترازو
    مشاهده بالینی
    #7
    Infants' head circumference
    Preterm delivery
    دور سر نوزادان
    زایمان زودرس
    Delivery time
    After delivery
    زمان زایمان
    بعد زایمان
    Tape
    Medical record
    متر نواری
    پرونده پزشکی
    #8
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    Maternal pre-eclampsia
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    پری اکلامپسی مادران باردار
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    After delivery
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    بعد زایمان
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    Medical record
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    پرونده پزشکی
    #9
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    Maternal hospitalization
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    بستری شدن مادران
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    After delivery
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    بعد زایمان
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    Medical record
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    پرونده پزشکی

  • Secondary outcomes

    #1
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    Hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
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    At the beginning of the study and after 6 weeks of intervention
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    در ابتدای مطالعه و 6 هفته بعد از مداخله
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    ELISA kit
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    کیت الایزا
    #2
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    Nitric oxide
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    نیتریک اکساید
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    At the beginning of the study and after 6 weeks of intervention
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    در ابتدای مطالعه و 6 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
    #3
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    Total antioxidant
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    توتال آنتی اکسیدانت
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    At the beginning of the study and after 6 weeks of intervention
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    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #4
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    Malondialdehyde
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    مالون دی آلدئید
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
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    Glutathione
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    گلوتاتیون
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    At the beginning of the study and after 6 weeks of intervention
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    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Spectrophotometry
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    اسپکتروفتومتری

  • Recruitment centers

    #1
    Name of recruitment center - English: Kossar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English:
    Street address - Persian:
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kossar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Emam Khomeyni Avenue, Arak
    Street address - Persian: اراک، خیابان امام خمینی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3814113634
    Phone: +98 86 3223 3823
    Fax:
    Email: jamilian.mehri@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mehri Jamilian
    Full name of responsible person - Persian: مهری جمیلیان
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3814113634
    Phone: +98 86 3223 3823
    Fax:
    Email: research@aums.ac.ir
    Web page address:
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    Public
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    Domestic
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    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: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: Nutrition PhD
    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 Science
    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: Nutrition PhD
    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: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: irasemi_r@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: 00
    Mobile: 00
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
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    undecided
    undecided
    undecided
    undecided
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    Undecided - It is not yet known if there will be a plan to make this available.
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    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 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 54 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation. Exclusion Criteria: Pre-existing diabetes, required complex diets, chronic medical conditions, significant psychiatric disease, smokers, kidney or liver diseases, chronic hypertension, hypothyroidism.
Intervention groups
Intervention group: Omega-3 pearl, 1000 mg, daily, for 6 weeks orally. Control group: Placebo pearl, daily, for 6 weeks orally.
Main outcome variables
Outcomes: Pregnancy outcomes (primary outcomes),hs-CRP, total nitrite and biomarkers of oxidative stress (secondary outcome) 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: IRCT201406305623N20
Registration date: 2014-07-16, 1393/04/25
Registration timing: retrospective

Last update: 2019-10-25, 1398/08/03
Update count: 1
Registration date
2014-07-16, 1393/04/25
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
Arak University of Medical Science
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-05-28, 1393/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 supplementation on inflammatory factors, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
Public title
Effect of supplementation in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
Pre-existing diabetes Required complex diets Chronic medical conditions Significant psychiatric disease Smokers Kidney or liver diseases Chronic hypertension Hypothyroidism
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the use of computer-generated random numbers.
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Approval date
2014-05-09, 1393/02/19
Ethics committee reference number
93-165-20

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
Infants' weight
Timepoint
Delivery time
Method of measurement
Scale

2

Description
Infants' head circumference
Timepoint
Delivery time
Method of measurement
Tape

3

Description
Newborns' length
Timepoint
Delivery time
Method of measurement
Tape

4

Description
Polyhydramnios
Timepoint
After the intervention
Method of measurement
Sonography

5

Description
Newborn's bilirubin
Timepoint
Delivery time
Method of measurement
Enzymatic kit

6

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

7

Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record

8

Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record

9

Description
Maternal hospitalization
Timepoint
After delivery
Method of measurement
Medical record

Secondary outcomes

1

Description
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
ELISA kit

2

Description
Nitric oxide
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Total antioxidant
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group: Omega-3 pearl, 1000 mg, daily, for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo pearl, daily, for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kossar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
jamilian.mehri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
research@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
81151-87159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition PhD
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
irasemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Science
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
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
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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