Clinical trial of the effect of omega-3 plus vitamin E supplementation compared to placebo on level of gene expression related to glycemic control and inflammatory factors in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of this study is to determine the effects of omega-3 plus vitamin E 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. Population and sample size: 60 eligible patients referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran will be included. Intervention: Patients will be assigned to receive either combined omega-3 fatty acids and vitamin E (n=30) or placebo (n=30). Combined omega-3 fatty acids and vitamin E and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of omega-3 plus vitamin E 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. Population and sample size: 60 eligible patients referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran will be included. Intervention: Patients will be assigned to receive either combined omega-3 fatty acids and vitamin E (n=30) or placebo (n=30). Combined omega-3 fatty acids and vitamin E and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. 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 امگا-3 بعلاوه ویتامین E 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: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک 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 یا مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین E (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین E 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.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بعلاوه ویتامین E 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: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک 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 یا مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین E (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل ترکیب اسیدهای چرب امگا-3 و ویتامین E 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.
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Objective: The aim of this study is to determine the effects of omega-3 plus vitamin E 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 omega-3 plus vitamin E supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بعلاوه ویتامین E 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 امگا-3 بعلاوه ویتامین E بر سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
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طراحي انجام مطالعه: کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
طراحي انجام مطالعه: کارآزمایی بالینی موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
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حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندرم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندرم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Smoking, intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months, intake of anti-inflammatory or antidiabetic drugs, pregnancy, other causes of hyperandrogenism and/or anovulation.
Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Smoking, intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months, intake of anti-inflammatory or antidiabetic drugs, pregnancy, other causes of hyperandrogenism and/or anovulation.
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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: سیگار کشیدن، دریافت مکمل اسیدهای چرب امگا-3 و/یا ویتامین ای در طی سه ماه قبل از مداخله، دریافت داروهای ضد التهابی یا آنتی دیابتیک، بارداری، سایر علت های هیپرآندروژنسیم و/یا عدم تخمک گذاری.
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: سیگار کشیدن، دریافت مکمل اسیدهای چرب امگا-3 و/یا ویتامین ای در طی سه ماه قبل از مداخله، دریافت داروهای ضد التهابی یا آنتی دیابتیک، بارداری، سایر علت های هیپرآندروژنسیم و/یا عدم تخمک گذاری.
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Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Control group: Placebo manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally. Control group: Placebo manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
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گروه مداخله: ترکیب 1000 میلی گرم اسیدهای چرب امگا-3 و 400 واحد ویتامین E، ساخت شرکت باریج اسانس، کاشان، ایران؛ یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه کنترل: پلاسبو ساخت شرکت باریج اسانس، کاشان، ایران، یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه مداخله: ترکیب 1000 میلی گرم اسیدهای چرب امگا-3 و 400 واحد ویتامین E، ساخت شرکت باریج اسانس، کاشان، ایران؛ یک بار در روز، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو ساخت شرکت باریج اسانس، کاشان، ایران، یک بار در روز، به صورت خوراکی برای 12 هفته.
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Outcomes: Parameters of mental health (primary outcomes), levels of gene expression related with glycemic control and inflammatory factors (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Parameters of mental health (primary outcomes), levels of gene expression related with glycemic control and inflammatory factors (secondary outcomes) will be quantified at study baseline and end-of-trial.
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پيامدها: پارامترهای سلامت روان (پیامدهای اولیه)، سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: پارامترهای سلامت روان (پیامدهای اولیه)، سطوح بیان ژن مرتبط با کنترل گلیسمیک و فاکتورهای التهابی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
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
Smoking
Intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months
Intake of anti-inflammatory or antidiabetic drugs
Pregnancy
Other causes of hyperandrogenism and/or anovulation
Smoking Intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months Intake of anti-inflammatory or antidiabetic drugs Pregnancy Other causes of hyperandrogenism and/or anovulation
سیگار کشیدن
دریافت مکمل اسیدهای چرب امگا-3 و/یا ویتامین ای در طی سه ماه قبل از مداخله
دریافت داروهای ضد التهابی یا آنتی دیابتیک
بارداری
سایر علت های هیپرآندروژنسیم و/یا عدم تخمک گذاری
سیگار کشیدن دریافت مکمل اسیدهای چرب امگا-3 و/یا ویتامین ای در طی سه ماه قبل از مداخله دریافت داروهای ضد التهابی یا آنتی دیابتیک بارداری سایر علت های هیپرآندروژنسیم و/یا عدم تخمک گذاری
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided 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 and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take supplements (n = 20) or placebo (n = 20). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی 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 و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی 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.
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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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Primary outcomes
#1
levels of GLUT1 gene expression
Beck scor
levels of GLUT1 gene expressionBeck scor
سطوح بیان ژن GLUT1
امتیاز بک
سطوح بیان ژن GLUT1امتیاز بک
PCR
Questionnaire
PCRQuestionnaire
PCR
پرسشنامه
PCRپرسشنامه
#2
level of PPAR-γ geene expression
GHQ score
level of PPAR-γ geene expressionGHQ score
سطوح بیان ژن PPAR-γ
امتیاز سلامت عمومی
سطوح بیان ژن PPAR-γامتیاز سلامت عمومی
PCR
Questionnaire
PCRQuestionnaire
PCR
پرسشنامه
PCRپرسشنامه
#3
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DASS-28 score
DASS-28 score
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امتیاز DASS-28
امتیاز DASS-28
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Questionnaire
Questionnaire
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پرسشنامه
پرسشنامه
Secondary outcomes
#1
level of IL-6 gene expression
level of IL-8 gene expression
level of IL-68 gene expression
سطوح بیان ژن اینترلوکین 6
سطوح بیان ژن اینترلوکین 8
سطوح بیان ژن اینترلوکین 68
#2
level of SOD gene expression
level of TGFB gene expression
level of SODTGFB gene expression
سطوح بیان ژن SOD
سطوح بیان ژن TGFB
سطوح بیان ژن SODTGFB
#3
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Gene expression of PPAR-gamma
Gene expression of PPAR-gamma
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سطوح بیان ژن PPAR-gamma
سطوح بیان ژن PPAR-gamma
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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PCR
PCR
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PCR
PCR
#4
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Gene expression of GLUT-1
Gene expression of GLUT-1
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سطوح بیان ژن GLUT-1
سطوح بیان ژن GLUT-1
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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PCR
PCR
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PCR
PCR
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: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
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: 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: 3819691187
Phone: +98 86 3313 6055
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: 3819691187 Phone: +98 86 3313 6055 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، خیابان سردشت، دانشگاه علوم پزشکی اراک،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، خیابان سردشت، دانشگاه علوم پزشکی اراک،معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3313 6055
Fax:
Email: research@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، خیابان سردشت، دانشگاه علوم پزشکی اراک،معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3313 6055 Fax: Email: research@aums.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:
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contact.provinces_available:
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contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: 00
Fax:
Email: asemi_r@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: 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: 8115187159
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: 8115187159 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: 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: 8115187159
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: 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: 8115187159 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 omega-3 plus vitamin E supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
Design
Study design: Parallel clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Smoking, intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months, intake of anti-inflammatory or antidiabetic drugs, pregnancy, other causes of hyperandrogenism and/or anovulation.
Intervention groups
Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Control group: Placebo manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Main outcome variables
Outcomes: Parameters of mental health (primary outcomes), levels of gene expression related with glycemic control and inflammatory factors (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number:IRCT201605215623N79
Registration date:2016-05-25, 1395/03/05
Registration timing:retrospective
Last update:2019-11-25, 1398/09/04
Update count:1
Registration date
2016-05-25, 1395/03/05
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, Arak University of Medical Sciences
Expected recruitment start date
2016-03-08, 1394/12/18
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of omega-3 plus vitamin E supplementation compared to placebo on level of gene expression related to 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:
Smoking
Intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months
Intake of anti-inflammatory or antidiabetic drugs
Pregnancy
Other causes of hyperandrogenism and/or anovulation
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 and after stratification for pre-intervention BMI and age, subjects will be randomly divided 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
Random assignment will be done by the use of computer-generated random numbers.
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 research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.ARAKMU.REC.1394.335
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
Beck scor
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
2
Description
GHQ score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
3
Description
DASS-28 score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
level of IL-1 gene expression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
level of IL-8 gene expression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
level of TNFα gene expression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
4
Description
level of TGFB gene expression
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Gene expression of PPAR-gamma
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Gene expression of GLUT-1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured byBarij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Category
Treatment - Drugs
Recruitment centers
1
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
3819691187
Phone
+98 86 3313 6055
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
3819693345
Phone
+98 86 3313 6055
Email
research@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
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
8115187159
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available