1. Home
  2. Approved trials
  3. » فارسی

Clinical trial of the effect of combined omega-3 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles and pregnancy outcomes in patients with gestational diabetes

View the latest revision

History
# Registration date Revision Id
2 2019-09-22, 1398/06/31 110737
1 2017-02-09, 1395/11/21 6136
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Objective: The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles and pregnancy outcomes in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 120 patients with gestational diabetes of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined omega-3 fatty acids or vitamin D (n=30), omega-3 fatty acids (n=30), vitamin D supplements (n=30) and placebo (n=30). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Inflammatory factors (primary outcomes), and oxidative stress factors and pregnancy outcomes will be quantified at study baseline and at the end of the trial.
    empty
    هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب اسیدهای چرب امگا-3 و ویتامین D بر پروفایل های متابولیک و پیامدهای بارداری در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: کارآزمایی بالینی تصادفي شده دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 120 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک علوی وابسته به دانشگاه علوم پزشکی اردبیل، اردبیل، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین D (30=n)، اسیدهای چرب امگا-3 (30=n)، ویتامین D (30=n) و پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین D، اسیدهای چرب امگا-3، ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: فاکتورهای التهابی (پیامدهای اولیه) و فاکتورهای استرس اکسیداتیو و پیامدهای بارداری در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    empty
    empty
    The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles and pregnancy outcomes in patients with gestational diabetes.
    empty
    هدف این مطالعه تعیین اثرات مکمل یاری ترکیب اسیدهای چرب امگا-3 و ویتامین D بر پروفایل های متابولیک و پیامدهای بارداری در بیماران مبتلا به دیابت بارداری است.
    empty
    Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment will be done by the use of computer-generated random numbers.
    empty
    طراحي انجام مطالعه: کارآزمایی بالینی تصادفي شده دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
    empty
    Population and sample size: 120 patients with gestational diabetes of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected.
    empty
    حجم نمونه و جمعیت مورد مطالعه: 120 بیمار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک علوی وابسته به دانشگاه علوم پزشکی اردبیل، اردبیل، ایران در مطالعه انتخاب خواهند شد.
    empty
    Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking omega-3 fatty acids supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism and Smokers
    empty
    معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: مصرف مکمل های اسیدهای چرب امگا 3، انسولین درمانی، جدا شدن زودرس جفت، پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید و افراد سیگاری.
    empty
    Intervention: Patients will be assigned to receive either combined omega-3 fatty acids or vitamin D (n=30), omega-3 fatty acids (n=30), vitamin D supplements (n=30) and placebo (n=30). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size.
    empty
    مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین D (30=n)، اسیدهای چرب امگا-3 (30=n)، ویتامین D (30=n) و پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین D، اسیدهای چرب امگا-3، ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند.
    empty
    Outcomes: Inflammatory factors (primary outcomes), and oxidative stress factors and pregnancy outcomes will be quantified at study baseline and at the end of the trial.
    empty
    پيامدها: فاکتورهای التهابی (پیامدهای اولیه) و فاکتورهای استرس اکسیداتیو و پیامدهای بارداری در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    1
    1
    1
    2
    3
    empty
    Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested changes are in accordance with the approved proposal and with the coordination of Vice Chancellor of Research of Ardabil University of Medical Sciences
    empty
    متاسفانه بدلیل کم توجهی، درخواست بروز رسانی بعد از چاپ مقاله انجام شده است. بعلاوه، موارد درخواست شده، مطابق با پروپوزال تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه علوم پزشکی اردبیل می باشد
    Patients with gestational diabetes
    Age range of 18 to 40 years
    بیماران مبتلا به دیابت بارداری
    در محدوده سنی 18 تا 40 سال
    Taking omega-3 fatty acids supplements
    Insulin therapy
    Placenta abruption
    Pre-eclampsia
    Eclampsia
    Hypo and hyperthyroidism
    Smokers
    مصرف مکمل های اسیدهای چرب امگا 3
    انسولین درمانی
    جدا شدن زودرس جفت
    پره اکلامپسی
    اکلامپسی
    کم کاری و پرکاری تیروئید
    افراد سیگاری
    empty
    Randomization will be done by the use of computer-generated random numbers.
    empty
    تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
    empty
    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology clinics, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.Participants, investigators or the assessors of the outcomes are unaware of the study groups.The appearance of the placebo capsule is indistinguishable in color, shape, size, and packaging, smell and taste from vitamin D and omega-3 fatty acids capsules.
    empty
    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک زنان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. ظاهر کپسول پلاسبو از نظر رنگ، شکل، اندازه، بسته بندی، بو و مزه شبیه کپسول های ویتامین دی و اسیدهای چرب امگا-3 می باشد.
    empty
    empty

  • Primary outcomes

    #1
    اسکتروفتومتری
    اسپکتروفتومتری

  • Secondary outcomes

    #1
    اسکتروفتومتری
    اسپکتروفتومتری
    #2
    اسکتروفتومتری
    اسپکتروفتومتری
    #3
    اسکتروفتومتری
    اسپکتروفتومتری
    #4
    empty
    Apgar score
    empty
    عدد آپگار
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #5
    empty
    Newborn's bilirubin
    empty
    بیلی روبین نوزادان تازه متولد شده
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Newborns' hospitalization
    empty
    بستری شدن نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #7
    empty
    Maternal pre-eclampsia
    empty
    پری اکلامپسی مادران باردار
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی

  • Intervention groups

    #1
    Intervention group: Combined 1000 mg omega-3 fatty acids (Barij Essence, Kashan, Iran) and 2000 IU vitamin D (Zahravi, Tabriz, Iran), twice a day, for 6 weeks orally.
    Intervention group: Combined 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
    گروه مداخله: ترکیب 1000میلی گرم اسیدهای چرب امگا-3 (باریج اسانس، کاشان، ایران) و 2000 واحد ویتامینD (زهراوی، تبریز، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته.
    گروه مداخله: ترکیب 2000 میلی گرم اسیدهای چرب امگا-3 روزانه (زهراوی، تبریز، ایران) و 50000 واحد ویتامین D هر دو هفته (زهراوی، تبریز، ایران)، به صورت خوراکی برای 6 هفته.
    #2
    Intervention group: 1000 mg omega-3 fatty acids (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
    Intervention group: 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran), for 6 weeks orally.
    گروه مداخله: 1000 میلی گرم اسیدهای چرب امگا-3 (باریج اسانس، کاشان، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته.
    گروه مداخله: 2000 میلی گرم اسیدهای چرب امگا-3 روزانه (زهراوی، تبریز، ایران)، به صورت خوراکی برای 6 هفته.
    #3
    Intervention group: 2000 IU vitamin D (Zahravi, Tabriz, Iran), twice a day, for 6 weeks orally.
    Intervention group: 5000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
    گروه مداخله: 2000 واحد ویتامین D (زهراوی، تبریز، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته.
    گروه مداخله: 50000 واحد ویتامین D هر دو هفته (زهراوی، تبریز، ایران)، به صورت خوراکی برای 6 هفته.
    #4
    Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 6 weeks orally.
    Control group: Omega-3 placebo daily (Zahravi, Tabriz, Iran) and vitamin D placebo every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
    گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، دو بار در روز، به صورت خوراکی برای 6 هفته.
    گروه کنترل: پلاسبو امگا-3 روزانه (زهراوی، تبریز، ایران) و پلاسبو ویتامین D هر دو هفته یک بار (زهراوی، تبریز، ایران)، به صورت خوراکی برای 6 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Alavi Clinic
    Name of recruitment center - Persian: کلینیک علوی
    Full name of responsible person - English: Maryamalsadat Razavi
    Full name of responsible person - Persian: مریم السادات رضوی
    Street address - English: Pasdaran Avenue, Ardabil
    Street address - Persian: اردبیل، خیابان پاسداران
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Alavi Clinic
    Name of recruitment center - Persian: کلینیک علوی
    Full name of responsible person - English: Maryamalsadat Razavi
    Full name of responsible person - Persian: مریم السادات رضوی
    Street address - English: Pasdaran Avenue, Ardabil
    Street address - Persian: اردبیل، خیابان پاسداران
    City - English: Ardabil
    City - Persian: اردبیل
    Province: Ardabil
    Country: Iran (Islamic Republic of)
    Postal code: 5613974156
    Phone: +98 45 3324 8888
    Fax:
    Email: alavi@arums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Ardabil University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Sharam Habibzadeh
    Full name of responsible person - Persian: شهرام حبیب زاده
    Street address - English: Ardabil University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی اردبیل
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Ardabil University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Sharam Habibzadeh
    Full name of responsible person - Persian: شهرام حبیب زاده
    Street address - English: Ardabil University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی اردبیل
    City - English: Ardabil
    City - Persian: اردبیل
    Province: Ardabil
    Country: Iran (Islamic Republic of)
    Postal code: 56189-85991
    Phone: +98 45 3353 4776
    Fax:
    Email: research@arums.ac.ir
    Web page address:
    empty
    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:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Ghotbe Ravandi Boulevard, Kashan
    Position - Persian: کاشان، بلوار قطب راوندی
    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: +98 913 361 5446
    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 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: PhD of Nutrition
    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: Ghotbe Ravandi Boulevard, 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: 00
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_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: PhD of Nutrition
    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: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    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: PhD of Nutrition
    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: Ghotbe Ravandi Boulevard, 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: 00
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_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: PhD of Nutrition
    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: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    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
The aim of this study is to determine the effects of combined omega-3 fatty acids and vitamin D supplementation on metabolic profiles and pregnancy outcomes in patients with gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled trial. Random assignment will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: 120 patients with gestational diabetes of eligible and referred to Alavi Clinic affiliated to Ardabil University of Medical Sciences, Ardabil, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking omega-3 fatty acids supplements, insulin therapy, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism and Smokers
Intervention groups
Intervention: Patients will be assigned to receive either combined omega-3 fatty acids or vitamin D (n=30), omega-3 fatty acids (n=30), vitamin D supplements (n=30) and placebo (n=30). Combined omega-3 fatty acids and vitamin D, omega-3 fatty acids, vitamin D supplements and placebos capsules are similar in shape and size.
Main outcome variables
Outcomes: Inflammatory factors (primary outcomes), and oxidative stress factors and pregnancy outcomes will be quantified at study baseline and at the end of the trial.

General information

Reason for update
Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested changes are in accordance with the approved proposal and with the coordination of Vice Chancellor of Research of Ardabil University of Medical Sciences
Acronym
IRCT registration information
IRCT registration number: IRCT201701305623N106
Registration date: 2017-02-09, 1395/11/21
Registration timing: retrospective

Last update: 2019-11-10, 1398/08/19
Update count: 1
Registration date
2017-02-09, 1395/11/21
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
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2016-09-08, 1395/06/18
Expected recruitment end date
2016-11-08, 1395/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined omega-3 fatty acids and vitamin D supplementation compared with the placebo on metabolic profiles and pregnancy outcomes in patients with gestational diabetes
Public title
Effect of supplementation in treatment of patients with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes Age range of 18 to 40 years
Exclusion criteria:
Taking omega-3 fatty acids supplements Insulin therapy Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 120
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
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology clinics, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.Participants, investigators or the assessors of the outcomes are unaware of the study groups.The appearance of the placebo capsule is indistinguishable in color, shape, size, and packaging, smell and taste from vitamin D and omega-3 fatty acids capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
5613974156
Approval date
2016-09-07, 1395/06/17
Ethics committee reference number
IR.ARUMS.REC.1395.35

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
E28.2
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary 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

Secondary outcomes

1

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

2

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

3

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

4

Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale

5

Description
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape

6

Description
Polyhydramnios
Timepoint
After the intervention
Method of measurement
Sonography

7

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

8

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

9

Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record

10

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

Intervention groups

1

Description
Intervention group: Combined 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Intervention group: 2000 mg omega-3 fatty acids daily (Zahravi, Tabriz, Iran), for 6 weeks orally.
Category
Treatment - Drugs

3

Description
Intervention group: 5000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
Category
Treatment - Drugs

4

Description
Control group: Omega-3 placebo daily (Zahravi, Tabriz, Iran) and vitamin D placebo every 2 weeks (Zahravi, Tabriz, Iran), for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi Clinic
Full name of responsible person
Maryamalsadat Razavi
Street address
Pasdaran Avenue, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
alavi@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Sharam Habibzadeh
Street address
Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3353 4776
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ardabil 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
Ghotbe Ravandi Boulevard, Kashan
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 Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
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

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
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
Loading...