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Protocol summary
Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles in gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at weeks 24-28 of gestation will be included. 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: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and 6 weeks after intervention to measure metabolic profiles. Start and end date of intervention: 6 weeks (September 1, 2015-October 17, 2015). Outcomes: Metabolic profiles will be measured at study baseline and end-of-trial.
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Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles in gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at weeks 24-28 of gestation will be included. 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: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and 6 weeks after intervention to measure metabolic profiles. Start and end date of intervention: 6 weeks (September 1, 2015-October 17, 2015). Outcomes: Metabolic profiles will be measured at study baseline and end-of-trial.
هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری 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: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار 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 ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک گرفته خواهد شد. زمان شروع و اتمام مداخله: 6 هفته (از 10 شهریور 1394 تا 25 مهر 1394). پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری 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: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار 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 ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک گرفته خواهد شد. زمان شروع و اتمام مداخله: 6 هفته (از 10 شهریور 1394 تا 25 مهر 1394). پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles in gestational diabetes.
The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles in gestational diabetes.
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هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک در دیابت بارداری است.
هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک در دیابت بارداری است.
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک زنان و زایمان وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک زنان و زایمان وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at weeks 24-28 of gestation will be included. Exclusion criteria: Pre-eclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and those requiring commencement of insulin therapy during treatment.
Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at weeks 24-28 of gestation will be included. Exclusion criteria: Pre-eclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and those requiring commencement of insulin therapy during treatment.
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معیار ورود مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری وارد خواهند شد. معیار خروج از مطالعه: پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری کلیوی و کبدی و افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند.
معیار ورود مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری وارد خواهند شد. معیار خروج از مطالعه: پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری کلیوی و کبدی و افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند.
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Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30).
Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30).
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مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. معیار خروج از مطالعه: پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری کلیوی و کبدی و افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند.
مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. معیار خروج از مطالعه: پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری کلیوی و کبدی و افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند.
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Outcomes: Markers of insulin resistance (primary outcomes) and lipid profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of insulin resistance (primary outcomes) and lipid profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
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پيامدها: مارکرهای مقاومت به انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای مقاومت به انسولین (پیامدهای اولیه) و پروفایل های لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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23
2015-08-23, 1394/06/01
2015-09-02, 1394/06/11
2015-0809-2302 00:00:00
2015-09-01, 1394/06/10
2015-09-18, 1394/06/27
2015-09-0118 00:00:00
Pregnant women aged 18-40 years
Diagnosed with GDM at weeks 24-28 of gestation
Pregnant women aged 18-40 years Diagnosed with GDM at weeks 24-28 of gestation
زنان باردار 40-18 ساله
مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری
زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته های 28-24 بارداری
Pre-eclampsia
Eclampsia
hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Those requiring commencement of insulin therapy during treatment.
Pre-eclampsia Eclampsia hypo- and hyperthyroidism Urinary tract infection Smokers Kidney or liver diseases Those requiring commencement of insulin therapy during treatment.
پره اکلامپسی
اکلامپسی
کم کاری و پرکاری تیروئید
عفونت ادراری
افراد سیگاری
بیماری کلیوی و کبدی
افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند
پره اکلامپسی اکلامپسی کم کاری و پرکاری تیروئید عفونت ادراری افراد سیگاری بیماری کلیوی و کبدی افرادی که نیاز به شروع انسولین درمانی در طول درمان دارند
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Randomization will be done by the use of computer-generated random numbers.
Randomization will be done by the use of computer-generated random numbers.
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تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده از جدول 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.
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.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Secondary outcomes
#1
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VLDL
VLDL
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VLDL
VLDL
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At the beginning of the study and after 6 weeks of intervention
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
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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LDL
LDL
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LDL
LDL
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At the beginning of the study and after 6 weeks of intervention
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
در ابتدای مطالعه و 6 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
Recruitment centers
#1
Name of recruitment center - English: Kosar 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: Gynecology Clinic
Name of recruitment center - Persian: کلینیک زنان و زایمان
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:
Name of recruitment center - English: KosarGynecology Clinic Name of recruitment center - Persian: کلینیک کوثرزنان و زایمان 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: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی 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 research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
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: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی 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 research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3814113634
Phone: +98 86 3223 3823
Fax:
Email: rafiee-m@aums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی 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 research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3814113634 Phone: +98 86 3223 3823 Fax: Email: rafiee-m@aums.ac.ir Web page address:
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Public
public
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Domestic
domestic
empty
Academic
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: 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: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: 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: 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: 1771844351 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: دکترای 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: +98 913 361 5446
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: دکترای 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: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac
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: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 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: 1771844351 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir-asemi_r@yahoo.comkaums.ac 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: +98 913 361 5446
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: 1771844351
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac
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: 034 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: 1771844351 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir-asemi_r@yahoo.comkaums.ac Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
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
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles in gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at weeks 24-28 of gestation will be included. Exclusion criteria: Pre-eclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and those requiring commencement of insulin therapy during treatment.
Intervention groups
Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Outcomes: Markers of insulin resistance (primary outcomes) and lipid profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201509115623N52
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:2019-09-22, 1398/06/31
Update count:1
Registration date
2015-09-16, 1394/06/25
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 Sciences
Expected recruitment start date
2015-09-02, 1394/06/11
Expected recruitment end date
2015-09-18, 1394/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin D and evening primrose oil supplementation on metabolic profiles 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 weeks 24-28 of gestation
Exclusion criteria:
Pre-eclampsia
Eclampsia
hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Those requiring commencement of insulin therapy during treatment.
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:
60
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
Ethics committee of 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
2015-09-01, 1394/06/10
Ethics committee reference number
IR.ARAKMU.REC.1394.161
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
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
VLDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
LDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, 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
Gynecology 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
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
rafiee-m@aums.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, 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
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
1771844351
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
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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