Clinical trial of the effect of melatonin supplementation compared with the placebo on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of this study is to determine the effects of melatonin supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30). melatonin and placebo 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 the end of the intervention: 12 weeks. Outcomes: Malondialdehyde (primary outcome) and hormonal profiles, inflammatory factors and gene expression related to inflammation (secondary outcome) 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 melatonin supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30). melatonin and placebo 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 the end of the intervention: 12 weeks. Outcomes: Malondialdehyde (primary outcome) and hormonal profiles, inflammatory factors and gene expression related to inflammation (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر پروفایل های هورمونی، فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و بیان ژن مرتبط با التهاب در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول 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. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مکمل ملاتونین (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ملاتونین 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: مالون دی آلدئید (پیامد اولیه) و پروفایل های هورمونی، فاکتورهای التهابی و بیان ژن مرتبط با التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر پروفایل های هورمونی، فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و بیان ژن مرتبط با التهاب در بیماران مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول 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. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مکمل ملاتونین (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ملاتونین 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: مالون دی آلدئید (پیامد اولیه) و پروفایل های هورمونی، فاکتورهای التهابی و بیان ژن مرتبط با التهاب (پیامدهای ثانویه) 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 melatonin supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome.
Objective: The aim of this study is to determine the effects of melatonin supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome.
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هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر پروفایل های هورمونی، فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و بیان ژن مرتبط با التهاب در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر پروفایل های هورمونی، فاکتورهای التهابی، بیومارکرهای استرس اکسیداتیو و بیان ژن مرتبط با التهاب در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplements (n=30) or placebo (n=30).
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplements (n=30) or placebo (n=30).
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طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل یاری (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل یاری (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
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Among patients with polycystic ovary syndrome referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Among patients with polycystic ovary syndrome referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک سرپایی کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک سرپایی کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
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Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, breastfeeding, patients with sleeping disorders, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction and/or diabetes.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, breastfeeding, patients with sleeping disorders, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction and/or diabetes.
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معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: بارداری، شیردهی، بیماران مبتلا به اختلالات خواب، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینیمیا، اختلال در عملکرد تیروئید و/یا دیابت.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: بارداری، شیردهی، بیماران مبتلا به اختلالات خواب، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینیمیا، اختلال در عملکرد تیروئید و/یا دیابت.
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Intervention group: 10 mg melatonin (Zahravi Pharmaceutical Company,Tabriz, Iran) daily for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Intervention group: 10 mg melatonin (Zahravi Pharmaceutical Company,Tabriz, Iran) daily for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
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گروه مداخله: 10 میلی گرم ملاتونین (شرکت دارویی ظهراوی، تبریز، ایران) روزانه برای 12 هفته به صورت خوراکی. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران) روزانه برای 12 هفته به صورت خوراکی.
گروه مداخله: 10 میلی گرم ملاتونین (شرکت دارویی ظهراوی، تبریز، ایران) روزانه برای 12 هفته به صورت خوراکی. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران) روزانه برای 12 هفته به صورت خوراکی.
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Outcomes: Malondialdehyde (primary outcome) and hormonal profiles, inflammatory factors and gene expression related to inflammation (secondary outcome) will be quantified at study baseline and end-of-trial.
Outcomes: Malondialdehyde (primary outcome) and hormonal profiles, inflammatory factors and gene expression related to inflammation (secondary outcome) will be quantified at study baseline and end-of-trial.
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پيامدها: مالون دی آلدئید (پیامد اولیه) و پروفایل های هورمونی، فاکتورهای التهابی و بیان ژن مرتبط با التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مالون دی آلدئید (پیامد اولیه) و پروفایل های هورمونی، فاکتورهای التهابی و بیان ژن مرتبط با التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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Patients with polycystic ovary syndrome aged 18 to 40 years
Patients with polycystic ovary syndrome aged 18 to 40 years
بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال
بارداری
شیردهی
بیماران مبتلا به اختلالات خواب
هیپرپلازی آدرنال
تومورهای ترشح کننده آندروژن
هیپرپرولاکتینیمیا
اختلال در عملکرد تیروئید و/یا دیابت
بارداری شیردهی بیماران مبتلا به اختلالات خواب هیپرپلازی آدرنال تومورهای ترشح کننده آندروژن هیپرپرولاکتینیمیا اختلال در عملکرد تیروئید و/یا دیابت
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To decrease potential confounding effects, after balanced randomisation, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
To decrease potential confounding effects, after balanced randomisation, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بالانس شده، افراد به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بالانس شده، افراد به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری 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
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Expressed levels of TGFB gene
Expressed levels of TGFB gene
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سطوح بیان TGFB
سطوح بیان TGFB
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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
#2
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Expressed levels of VEGF gene
Expressed levels of VEGF gene
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سطوح بیان VEGF
سطوح بیان VEGF
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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
#3
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Modified Ferriman Gallwey
Modified Ferriman Gallwey
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فری من گال وی تعدیل شده
فری من گال وی تعدیل شده
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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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Questioner
Questioner
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پرسشنامه
پرسشنامه
Intervention groups
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Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
Intervention group: Melatonin supplements (NUTRALabZahravi, ScarboroughTabriz, CanadaIran), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
گروه مداخله: مکمل ملاتونین (نوترالب، کانادا)، 5 میلی گرم، دو کپسول 1 ساعت قبل از خواب برای 12 هفته به صورت خوراکی
گروه مداخله: مکمل ملاتونین (ظهراوی، تبریز، ایران)، 5 میلی گرم، دو کپسول 1 ساعت قبل از خواب برای 12 هفته به صورت خوراکی
گروه مداخله: مکمل ملاتونین (نوترالبظهراوی، کاناداتبریز، ایران)، 5 میلی گرم، دو کپسول 1 ساعت قبل از خواب برای 12 هفته به صورت خوراکی
Recruitment centers
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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: 3817713314
Phone: +98 86 4223 6559
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: 3817713314 Phone: +98 86 4223 6559 Fax: Email: jamilian.mehri@gmail.com Web page address:
Sponsors / Funding sources
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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: ali arash anoushirvani
Full name of responsible person - Persian: علی آرش انوشیروانی
Street address - English: Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
Street address - Persian: خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک
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: Ali arash Anoushirvani
Full name of responsible person - Persian: علی آرش انوشیروانی
Street address - English: Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
Street address - Persian: خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3817713314
Phone: +98 86 4223 6559
Fax:
Email: Anoushirvani-aa@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: aliAli arash anoushirvaniAnoushirvani Full name of responsible person - Persian: علی آرش انوشیروانی Street address - English: Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences Street address - Persian: خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3817713314 Phone: +98 86 4223 6559 Fax: Email: Anoushirvani-aa@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: 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: Ph.D 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: Ph.D 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: Ph.D 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 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: Ph.D 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: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
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: 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: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd 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: 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:
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: Ph.D 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: Name of organization / entity - Persian: Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D 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:
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 melatonin supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplements (n=30) or placebo (n=30).
Settings and conduct
Among patients with polycystic ovary syndrome referred to Kosar outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, breastfeeding, patients with sleeping disorders, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction and/or diabetes.
Intervention groups
Intervention group: 10 mg melatonin (Zahravi Pharmaceutical Company,Tabriz, Iran) daily for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Main outcome variables
Outcomes: Malondialdehyde (primary outcome) and hormonal profiles, inflammatory factors and gene expression related to inflammation (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017082733941N9
Registration date:2017-09-18, 1396/06/27
Registration timing:retrospective
Last update:2019-09-16, 1398/06/25
Update count:1
Registration date
2017-09-18, 1396/06/27
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2017-08-30, 1396/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of melatonin supplementation compared with the placebo on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in women with polycystic ovary syndrome
Public title
Effect of melatonin supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome aged 18 to 40 years
To decrease potential confounding effects, after balanced randomisation, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3817713314
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.ARAKMU.REC.1396.89
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
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
4
Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
8
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
9
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
10
Description
Expressed levels of TGFB gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
11
Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
12
Description
Modified Ferriman Gallwey
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questioner
Intervention groups
1
Description
Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks 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
3817713314
Phone
+98 86 4223 6559
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
Ali arash Anoushirvani
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3817713314
Phone
+98 86 4223 6559
Email
Anoushirvani-aa@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
Ph.D 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 scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
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
Ph.D 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
Email
asemi_r@yahoo.com
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