Clinical trial of the effect of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, anti-diabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and end date of intervention: 12 weeks (August 23, 2015-November 21, 2015). Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
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Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, women aged 18-40 years diagnosed with PCOS will be included. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, anti-diabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 patients with PCOS among women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either combined vitamin D and evening primrose oil supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 weeks of intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and end date of intervention: 12 weeks (August 23, 2015-November 21, 2015). Outcomes: Metabolic profiles and biomarkers of oxidative stress will be measured at study baseline and after 12 weeks of intervention.
هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک و استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. افراد مبتلا به نئوپلاستیک، اختلالات قلبی-عروقی، اختلالات سوء جذبی، استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون، داروهای ضد دیابتیک و داروهای ضد چاقی از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو گرفته خواهد شد. زمان شروع و اتمام مداخله: 12 هفته (از 1 شهریور 1394 تا 30 آبان 1394). پيامدها: پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
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هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک و استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان 40-18 ساله مبتلا به سندروم تخمدان پلی کیستیک وارد خواهند شد. افراد مبتلا به نئوپلاستیک، اختلالات قلبی-عروقی، اختلالات سوء جذبی، استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون، داروهای ضد دیابتیک و داروهای ضد چاقی از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به سندروم تخمدان پلی کیستیک در میان زنان واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ترکیب ویتامین D و روغن گل مغربی (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو گرفته خواهد شد. زمان شروع و اتمام مداخله: 12 هفته (از 1 شهریور 1394 تا 30 آبان 1394). پيامدها: پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
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Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS).
Objective: The aim of the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS).
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هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک و استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب ویتامین D و روغن گل مغربی بر پروفایل های متابولیک و استرس اکسیداتیو در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
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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.
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.
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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.
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.
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Population and sample size: 60 patients of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Population and sample size: 60 patients of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 60 بیمار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 بیمار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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Inclusion criteria: Women aged 18-40 years diagnosed with PCOS.Exclusion criteria: Elevated levels of prolactin, thyroid disorder, endocrine diseases including individuals with diabetes, impaired glucose tolerance, gastrointestinal diseases.
Inclusion criteria: Women aged 18-40 years diagnosed with PCOS.Exclusion criteria: Elevated levels of prolactin, thyroid disorder, endocrine diseases including individuals with diabetes, impaired glucose tolerance, gastrointestinal diseases.
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معیارهای ورود مطالعه: زنان 40-18 ساله تشخیص داده شده به سندروم تخمدان پلی کیستیک. معیار خروج از مطالعه: افزایش سطوح پرولاکتین، اختلال تیروئید، بیماری های آندوکرین از قبیل دیابت، اختلال در تحمل گلوکز، بیماری های دستگاه گوارش.
معیارهای ورود مطالعه: زنان 40-18 ساله تشخیص داده شده به سندروم تخمدان پلی کیستیک. معیار خروج از مطالعه: افزایش سطوح پرولاکتین، اختلال تیروئید، بیماری های آندوکرین از قبیل دیابت، اختلال در تحمل گلوکز، بیماری های دستگاه گوارش.
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Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally.
Control group: Placebo pearl, daily, for 12 weeks orally.
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally. Control group: Placebo pearl, daily, for 12 weeks orally.
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گروه مداخله: پرل ترکیب ویتامین D و روغن گل مغربی، 1000 واحد ویتامین D بعلاوه 1000 میلی گرم روغن گل مغربی، روزانه، به صورت خوراکی برای 12 هفته.
گروه کنترل: پرل پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
گروه مداخله: پرل ترکیب ویتامین D و روغن گل مغربی، 1000 واحد ویتامین D بعلاوه 1000 میلی گرم روغن گل مغربی، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پرل پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
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Outcomes: Lipid profiles (primary outcomes) and biomarkers of oxidative stress (secondary outcomes) will be measured at study baseline and after 12 weeks of intervention.
Outcomes: Lipid profiles (primary outcomes) and biomarkers of oxidative stress (secondary outcomes) will be measured at study baseline and after 12 weeks of intervention.
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پيامدها: پروفایل های لیپیدی (پیامدهای اولیه) و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
پيامدها: پروفایل های لیپیدی (پیامدهای اولیه) و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و 12 هفته بعد از مداخله اندازه گیری خواهد شد.
General information
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2015-08-12, 1394/05/21
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2015-08-22, 1394/05/31
2015-08-06, 1394/05/15
2015-08-2206 00:00:00
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Due to an error, the request for an update in our website was 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 was 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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بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Women aged 18-40 years diagnosed with PCOS
Women aged 18-40 years diagnosed with PCOS
زنان 40-18 ساله تشخیص داده شده به سندروم تخمدان پلی کیستیک
زنان 40-18 ساله تشخیص داده شده به سندروم تخمدان پلی کیستیک
Elevated levels of prolactin
Thyroid disorder
Endocrine diseases including individuals with diabetes, impaired glucose tolerance
Gastrointestinal diseases
Elevated levels of prolactin Thyroid disorder Endocrine diseases including individuals with diabetes, impaired glucose tolerance Gastrointestinal diseases
افزایش سطوح پرولاکتین
اختلال تیروئید
بیماری های آندوکرین از قبیل دیابت، اختلال در تحمل گلوکز
بیماری های دستگاه گوارش
افزایش سطوح پرولاکتین اختلال تیروئید بیماری های آندوکرین از قبیل دیابت، اختلال در تحمل گلوکز بیماری های دستگاه گوارش
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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=30) or the standard diet (n=30). 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=30) or the standard diet (n=30). 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=30) و پلاسبو (n=30) 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=30) و پلاسبو (n=30) 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
Insulin
Triglycerides
InsulinTriglycerides
انسولین
تری گلیسرید
انسولینتری گلیسرید
Elisa
Enzymatic kit
ElisaEnzymatic kit
الایزا
کیت آنزیمی
الایزاکیت آنزیمی
#2
Insulin resistance
HDL-cholesterol
Insulin resistanceHDL-cholesterol
مقاومت به انسولین
کلسترول HDL
مقاومت به انسولینکلسترول HDL
Calculation
Enzymatic kit
CalculationEnzymatic kit
محاسبه
کیت آنزیمی
محاسبهکیت آنزیمی
#3
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Total cholesterol
Total cholesterol
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کلسترول تام
کلسترول تام
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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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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#4
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LDL
LDL
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LDL
LDL
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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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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#5
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VLDL
VLDL
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VLDL
VLDL
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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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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
Secondary outcomes
#1
Triglycerides
Serum vitamin D
TriglyceridesSerum vitamin D
تری گلیسرید
ویتامین دی سرمی
تری گلیسریدویتامین دی سرمی
Enzymatic
Elisa kit
EnzymaticElisa kit
آنزیمی
کیت الایزا
آنزیمیکیت الایزا
#2
Total cholesterol
Hirsutism
Total cholesterolHirsutism
کلسترول تام
هیرسوتیسم
کلسترول تامهیرسوتیسم
Enzymatic
Clinical observation
EnzymaticClinical observation
آنزیمی
مشاهده بالینی
آنزیمیمشاهده بالینی
#3
HDL-cholesterol
Total antioxidant
HDL-cholesterolTotal antioxidant
کلسترول HDL
آنتی اکسیدانت توتال
کلسترول HDLآنتی اکسیدانت توتال
Enzymatic
Spectrophotometry
EnzymaticSpectrophotometry
آنزیمی
اسپکتروفتومتری
آنزیمیاسپکتروفتومتری
#4
Fasting blood sugar
Glutathione
Fasting blood sugarGlutathione
قند خون ناشتا
گلوتاتیون
قند خون ناشتاگلوتاتیون
Enzymatic
Spectrophotometry
EnzymaticSpectrophotometry
آنزیمی
اسپکتروفتومتری
آنزیمیاسپکتروفتومتری
#5
Total antioxidant
Malondialdehyde
Total antioxidantMalondialdehyde
آنتی اکسیدانت توتال
مالون دی آلدئید
آنتی اکسیدانت توتالمالون دی آلدئید
#6
Glutathione
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Glutathione
گلوتاتیون
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گلوتاتیون
At the beginning of the study and after 12 weeks of intervention
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At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
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در ابتدای مطالعه و 12 هفته بعد از مداخله
Spectrophotometry
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Spectrophotometry
اسپکتروفتومتری
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اسپکتروفتومتری
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Khadijeh Nasri
Full name of responsible person - Persian: خدیجه نصری
Street address - English:
Street address - Persian:
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Kosar outpatient Clinic
Name of recruitment center - Persian: کلینیک سرپایی کوثر
Full name of responsible person - English: Khadijeh Nasri
Full name of responsible person - Persian: خدیجه نصری
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: 3848176941
Phone: +98 84 3223 3823
Fax:
Email: nasri-k@aums.ac.ir
Web page address:
Name of recruitment center - English: Kosar outpatient Clinic Name of recruitment center - Persian: کلینیک سرپایی کوثر Full name of responsible person - English: Khadijeh Nasri Full name of responsible person - Persian: خدیجه نصری 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: 3848176941 Phone: +98 84 3223 3823 Fax: Email: nasri-k@aums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Arak University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Arak University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3848176941
Phone: +98 84 3223 3823
Fax:
Email: research@aums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Arak University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک Full name of responsible person - English: Mohammad Rafiee Full name of responsible person - Persian: محمد رفیعی Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، معاونت پژوهشی دانشگاه علوم پزشکی اراک، خیابان سردشت، معاونت پژوهشی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3848176941 Phone: +98 84 3223 3823 Fax: Email: research@aums.ac.ir Web page address:
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public
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domestic
empty
Academic
academic
Person responsible for general inquiries
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Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
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Latest degree:
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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: 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: 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: 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: 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: 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.
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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 the current study is to evaluate the effects of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress in women with polycystic ovary syndrome (PCOS).
Design
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.
Settings and conduct
Population and sample size: 60 patients of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18-40 years diagnosed with PCOS.Exclusion criteria: Elevated levels of prolactin, thyroid disorder, endocrine diseases including individuals with diabetes, impaired glucose tolerance, gastrointestinal diseases.
Intervention groups
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally.
Control group: Placebo pearl, daily, for 12 weeks orally.
Main outcome variables
Outcomes: Lipid profiles (primary outcomes) and biomarkers of oxidative stress (secondary outcomes) will be measured at study baseline and after 12 weeks of intervention.
General information
Reason for update
Due to an error, the request for an update in our website was 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:IRCT201508025623N48
Registration date:2015-08-06, 1394/05/15
Registration timing:retrospective
Last update:2019-10-18, 1398/07/26
Update count:2
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-08-03, 1394/05/12
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin D and evening primrose oil supplementation on metabolic profiles and oxidative stress 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:
Women aged 18-40 years diagnosed with PCOS
Exclusion criteria:
Elevated levels of prolactin
Thyroid disorder
Endocrine diseases including individuals with diabetes, impaired glucose tolerance
Gastrointestinal diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take supplements (n=30) or the standard diet (n=30). 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
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
3848176941
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.ARAKMU.REC.1394.92
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
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
VLDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Secondary outcomes
1
Description
Serum vitamin D
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Hirsutism
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical observation
3
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Combined vitamin D and evening primrose oil pearl, 1000 IU vitamin D plus 1000 mg evening primrose oil, daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar outpatient Clinic
Full name of responsible person
Khadijeh Nasri
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 84 3223 3823
Email
nasri-k@aums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
3848176941
Phone
+98 84 3223 3823
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
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
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