Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome
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 fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome 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: 60 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran in the study will be selected. Intervention: Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
empty
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome 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: 60 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran in the study will be selected. Intervention: Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی 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 سندروم تخمدان پلی کیستیک 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: 40 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، بوشهر، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل روغن ماهی (20=n) یا پلاسبو (20=n) تقسیم خواهند شد. کپسول های مکمل روغن ماهی و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی 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 سندروم تخمدان پلی کیستیک 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: 40 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، بوشهر، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل روغن ماهی (20=n) یا پلاسبو (20=n) تقسیم خواهند شد. کپسول های مکمل روغن ماهی و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری روغن ماهی بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
empty
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
empty
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.
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.
empty
Population and sample size: 40 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran and Kosar affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Population and sample size: 40 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran and Kosar affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
empty
حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، بوشهر، ایران و کلینیک کوثر وابسته به دانشگاه اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 40 بیمار مبتلا به سندروم تخمدان پلی کیستیک واجد شرایط و ارجاع شده به بیمارستان شهدای خلیج فارس وابسته به دانشگاه علوم پزشکی بوشهر، بوشهر، ایران و کلینیک کوثر وابسته به دانشگاه اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
empty
Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Pregnant women, diabetes and impaired glucose tolerance, hypo or hyperthyroidism, androgen-secreting tumor, or hyperprolactinemia.
Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Pregnant women, diabetes and impaired glucose tolerance, hypo or hyperthyroidism, androgen-secreting tumor, or hyperprolactinemia.
empty
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: زنان باردار، دیابت یا عدم تحمل گلوکز، کم یا پرکاری تیروئید، تومور ترشج کننده آندروژن یا افزایش پرولاکتین خون.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: زنان باردار، دیابت یا عدم تحمل گلوکز، کم یا پرکاری تیروئید، تومور ترشج کننده آندروژن یا افزایش پرولاکتین خون.
empty
Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size.
Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size.
empty
مداخله مورد مطالعه: بیماران برای دریافت یا مکمل روغن ماهی (20=n) یا پلاسبو (20=n) تقسیم خواهند شد. کپسول های مکمل روغن ماهی و پلاسبو از نظر شکل و اندازه مشابه هستند.
مداخله مورد مطالعه: بیماران برای دریافت یا مکمل روغن ماهی (20=n) یا پلاسبو (20=n) تقسیم خواهند شد. کپسول های مکمل روغن ماهی و پلاسبو از نظر شکل و اندازه مشابه هستند.
empty
Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
empty
پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: سطوح بیان ژن مرتبط با کنترل گلیسمیک (پیامدهای اولیه) و فاکتورهای التهابی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
1
1
1
1
1
1
2
3
23
empty
Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested issues are in accordance with the approved proposal or with the coordination of Vice Chancellor of Research of University.
Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested issues are in accordance with the approved proposal or with the coordination of Vice Chancellor of Research of University.
empty
متاسفانه بدلیل کم توجهی، درخواست بروز رسانی بعد از چاپ مقاله انجام شد. بعلاوه، موارد درخواست شده، مطابق با پروپوزال تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه می باشد.
متاسفانه بدلیل کم توجهی، درخواست بروز رسانی بعد از چاپ مقاله انجام شد. بعلاوه، موارد درخواست شده، مطابق با پروپوزال تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه می باشد.
Patients with PCOS according to Rotterdam criteria aged 18 to 40 years
Patients with PCOS according to Rotterdam criteria aged 18 to 40 years
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال
Pregnant women
Diabetes and impaired glucose tolerance
Hypo or hyperthyroidism
Androgen-secreting tumor
Hyperprolactinemia
Pregnant women Diabetes and impaired glucose tolerance Hypo or hyperthyroidism Androgen-secreting tumor Hyperprolactinemia
زنان باردار
دیابت یا عدم تحمل گلوکز
کم یا پرکاری تیروئید
تومور ترشج کننده آندروژن
افزایش پرولاکتین خون
زنان باردار دیابت یا عدم تحمل گلوکز کم یا پرکاری تیروئید تومور ترشج کننده آندروژن افزایش پرولاکتین خون
empty
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to take supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to take supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
empty
در ابتدای مطالعه، بعد از تصادفی سازی بلوکی بالانس شده، افراد به دو گروه برای دریافت مکمل (n=20) و پلاسبو (n=20) تخصیص داده می شوند. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه، بعد از تصادفی سازی بلوکی بالانس شده، افراد به دو گروه برای دریافت مکمل (n=20) و پلاسبو (n=20) تخصیص داده می شوند. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
empty
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.
empty
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.
empty
empty
Secondary outcomes
#1
Interleukin 6
Interleukin 8
Interleukin 68
اینترلوکین 6
اینترلوکین 8
اینترلوکین 68
#2
empty
Interleukin 1
Interleukin 1
empty
اینترلوکین 1
اینترلوکین 1
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#3
empty
LDLR
LDLR
empty
LDLR
LDLR
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#4
empty
Lp(a)
Lp(a)
empty
Lp(a)
Lp(a)
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#5
empty
TGF-β
TGF-β
empty
TGF-β
TGF-β
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
Recruitment centers
#1
Name of recruitment center - English: Persian Gulf Martyrs Hospital
Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس
Full name of responsible person - English: Dr Elham Rahmani
Full name of responsible person - Persian: دکتر الهام رحمانی
Street address - English: Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
Street address - Persian: میدان برج، بلوار برج، بیمارستان شهدای خلیج فارس
City - English: Bushehr
City - Persian: بوشهر
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Persian Gulf Martyrs Hospital
Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس
Full name of responsible person - English: Dr Elham Rahmani
Full name of responsible person - Persian: دکتر الهام رحمانی
Street address - English: Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
Street address - Persian: میدان برج، بلوار برج، بیمارستان شهدای خلیج فارس
City - English: Bushehr
City - Persian: بوشهر
Province: Boushehr
Country: Iran (Islamic Republic of)
Postal code: 7518759577
Phone: +98 77 3345 0089
Fax:
Email: rahmani-e@bums.ac.ir
Web page address:
Name of recruitment center - English: Persian Gulf Martyrs Hospital Name of recruitment center - Persian: بیمارستان شهدای خلیج فارس Full name of responsible person - English: Dr Elham Rahmani Full name of responsible person - Persian: دکتر الهام رحمانی Street address - English: Persian Gulf Martyrs Hospital, Borj square, Borj Blvd Street address - Persian: میدان برج، بلوار برج، بیمارستان شهدای خلیج فارس City - English: Bushehr City - Persian: بوشهر Province: Boushehr Country: Iran (Islamic Republic of) Postal code: 7518759577 Phone: +98 77 3345 0089 Fax: Email: rahmani-e@bums.ac.ir Web page address:
#2
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: 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: 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: 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 of research, Bushehr University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی
Full name of responsible person - English: Dr Afshin Ostovar
Full name of responsible person - Persian: دکتر افشین استوار
Street address - English: Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
Street address - Persian: بلوار سبزآباد، دانشگاه علوم پزشکی، پردیس بهمنی
City - English: Bushehr
City - Persian: بوشهر
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor of research, Bushehr University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی
Full name of responsible person - English: Dr Afshin Ostovar
Full name of responsible person - Persian: دکتر افشین استوار
Street address - English: Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
Street address - Persian: بلوار سبزآباد، دانشگاه علوم پزشکی، پردیس بهمنی
City - English: Bushehr
City - Persian: بوشهر
Province: Boushehr
Country: Iran (Islamic Republic of)
Postal code: 7514633341
Phone: +98 77 3345 0089
Fax:
Email: research@bums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor of research, Bushehr University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی بوشهر، معاونت پژوهشی Full name of responsible person - English: Dr Afshin Ostovar Full name of responsible person - Persian: دکتر افشین استوار Street address - English: Bahmani Campus, University of Medical Sciences, Sabzabad Blvd Street address - Persian: بلوار سبزآباد، دانشگاه علوم پزشکی، پردیس بهمنی City - English: Bushehr City - Persian: بوشهر Province: Boushehr Country: Iran (Islamic Republic of) Postal code: 7514633341 Phone: +98 77 3345 0089 Fax: Email: research@bums.ac.ir Web page address:
empty
Public
public
empty
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:
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_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: 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: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: 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: 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: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذ ات 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: ذ ات 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: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: 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: ذ ات 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: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com 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
Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
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: 40 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran and Kosar affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Pregnant women, diabetes and impaired glucose tolerance, hypo or hyperthyroidism, androgen-secreting tumor, or hyperprolactinemia.
Intervention groups
Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size.
Main outcome variables
Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
General information
Reason for update
Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested issues are in accordance with the approved proposal or with the coordination of Vice Chancellor of Research of University.
Acronym
IRCT registration information
IRCT registration number:IRCT201609305623N89
Registration date:2016-10-01, 1395/07/10
Registration timing:retrospective
Last update:2019-10-18, 1398/07/26
Update count:1
Registration date
2016-10-01, 1395/07/10
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 of research, Bushehr University of
Medical Sciences
Expected recruitment start date
2016-09-24, 1395/07/03
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of fish oil supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with PCOS according to Rotterdam criteria aged 18 to 40 years
Exclusion criteria:
Pregnant women
Diabetes and impaired glucose tolerance
Hypo or hyperthyroidism
Androgen-secreting tumor
Hyperprolactinemia
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to take supplements (n=20) or placebo (n=20). 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 Bushehr University of Medical Sciences
Street address
Bahmani Campus, Bushehr University of Medical Sciences, Sabzabad Blvd
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2016-09-24, 1395/07/03
Ethics committee reference number
IR.BPUMS.REC.1395.86
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
PPAR-γ
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
GLUT-1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Interleukin 8
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
Tumor necrosis factor alpha
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
Interleukin 1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
4
Description
LDLR
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Lp(a)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
TGF-β
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), twice a day, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Martyrs Hospital
Full name of responsible person
Dr Elham Rahmani
Street address
Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0089
Email
rahmani-e@bums.ac.ir
2
Recruitment center
Name of recruitment center
Kosar 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 of research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0089
Email
research@bums.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 of research, Bushehr 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_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
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_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
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_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available