Clinical trial of the effect of carnitine supplementation compared with the placebo on carotid intima-media thickness and biomarkers of 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 carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women 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 will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned to receive either carnitine (n=30) or placebo (n=30). Carnitine 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 end of the intervention: 12 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes) 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 carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women 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 will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned to receive either carnitine (n=30) or placebo (n=30). Carnitine 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 end of the intervention: 12 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری کارنیتین بر ضخامت انتیما-مدیای شریان کاروتید و بیومارکرهای التهاب در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. 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. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل کارنیتین (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های کارنیتین 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: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و بیومارکرهای التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری کارنیتین بر ضخامت انتیما-مدیای شریان کاروتید و بیومارکرهای التهاب در زنان مبتلا به سندروم تخمدان پلی کیستیک است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. 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. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل کارنیتین (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های کارنیتین 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: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و بیومارکرهای التهاب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women with polycystic ovary syndrome.
The aim of this study is to determine the effects of carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women with polycystic ovary syndrome.
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هدف این مطالعه تعیین اثرات مکمل یاری کارنیتین بر ضخامت انتیما-مدیای شریان کاروتید و بیومارکرهای التهاب در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
هدف این مطالعه تعیین اثرات مکمل یاری کارنیتین بر ضخامت انتیما-مدیای شریان کاروتید و بیومارکرهای التهاب در زنان مبتلا به سندروم تخمدان پلی کیستیک است.
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Parallel double-blind (both patients and researchers) clinical trial
Parallel double-blind (both patients and researchers) clinical trial
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کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, elevated levels of prolactin, and endocrine diseases.
Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, elevated levels of prolactin, and endocrine diseases.
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یماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر خواهد بود: زنان باردار ، افزایش سطح پرولاکتین و بیماریهای غدد درون ریز.
یماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیارهای خروج به شرح زیر خواهد بود: زنان باردار ، افزایش سطح پرولاکتین و بیماریهای غدد درون ریز.
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Patients will be assigned to receive either carnitine (n=30) or placebo (n=30).
Patients will be assigned to receive either carnitine (n=30) or placebo (n=30).
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بیماران برای دریافت مکمل کارنیتین (30=n) یا پلاسبو (30=n) تقسیم خواهند شد.
بیماران برای دریافت مکمل کارنیتین (30=n) یا پلاسبو (30=n) تقسیم خواهند شد.
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Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes)
Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes)
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ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و بیومارکرهای التهاب (پیامدهای ثانویه)
ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و بیومارکرهای التهاب (پیامدهای ثانویه)
General information
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2016-11-21, 1395/09/01
2016-07-11, 1395/04/21
2016-07-11-21 00:00:00
2016-12-21, 1395/10/01
2016-08-11, 1395/05/21
2016-1208-2111 00:00:00
Patients with polycystic ovary syndrome according to Rotterdam criteria
Aged 18 to 40 years
Patients with polycystic ovary syndrome according to Rotterdam criteria Aged 18 to 40 years
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
سنی 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام سنی 18 تا 40 سال
Pregnant women
Elevated levels of prolactin
Endocrine diseases
Pregnant women Elevated levels of prolactin Endocrine diseases
زنان باردار
افزایش سطوح پرولاکتین
بیماری های اندوکرین
زنان باردار افزایش سطوح پرولاکتین بیماری های اندوکرین
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At study baseline and after balanced blocked randomization, subjects will be randomly divided into two groups to take either carnitine supplements (n = 30) or placebo (n =30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after balanced blocked randomization, subjects will be randomly divided into two groups to take either carnitine supplements (n = 30) or placebo (n =30). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از تصادفی بلوکی تعادلی، افراد به طور تصادفی به دو گروه برای دریافت مکمل کارنیتین (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از تصادفی بلوکی تعادلی، افراد به طور تصادفی به دو گروه برای دریافت مکمل کارنیتین (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک نقوی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک نقوی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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Recruitment centers
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Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Naghavi Clinic Name of recruitment center - Persian: کلینیک نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
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 36 1534 3570
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
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: 81151-87159
Phone: +98 36 1534 3570
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
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: 81151-87159 Phone: +98 36 1534 3570 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:
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: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: 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: 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
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Full name of responsible person - English: وحید رضا استاد محمدی
Full name of responsible person - Persian: Vahidreza Ostadmohammadi
Position - English: Student
Position - Persian: دانشجو
Latest degree: med_doctor
Area of specialty/work: 30
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Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
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Province: Isfehan
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contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5556 0608
Mobile: +98 912 633 9401
Fax:
Email: ostadmohammadi-vr@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: وحید رضا استاد محمدی Full name of responsible person - Persian: Vahidreza Ostadmohammadi Position - English: Student Position - Persian: دانشجو Latest degree: med_doctor Area of specialty/work: 30 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 5556 0608 Mobile: +98 912 633 9401 Fax: Email: ostadmohammadi-vr@kaums.ac.ir 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
The aim of this study is to determine the effects of carnitine supplementation on carotid intima-media thickness (CIMT) and biomarkers of inflammation in women with polycystic ovary syndrome.
Design
Parallel double-blind (both patients and researchers) clinical trial
Settings and conduct
Among patients with polycystic ovary syndrome referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, elevated levels of prolactin, and endocrine diseases.
Intervention groups
Patients will be assigned to receive either carnitine (n=30) or placebo (n=30).
Main outcome variables
Carotid intima-media thickness (primary outcome) and biomarkers of inflammation (secondary outcomes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017070433941N3
Registration date:2017-07-31, 1396/05/09
Registration timing:retrospective
Last update:2019-09-24, 1398/07/02
Update count:1
Registration date
2017-07-31, 1396/05/09
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, Kashan University of Medical Sciences
Expected recruitment start date
2016-07-11, 1395/04/21
Expected recruitment end date
2016-08-11, 1395/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of carnitine supplementation compared with the placebo on carotid intima-media thickness and biomarkers of inflammation in women with polycystic ovary syndrome
Public title
Effect of carnitine supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant women
Elevated levels of prolactin
Endocrine diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
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 balanced blocked randomization, subjects will be randomly divided into two groups to take either carnitine supplements (n = 30) or placebo (n =30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.KAUMS.REC.1395.21
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
Mean left CIMT
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Sonography
2
Description
Maximum left CIMT
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Sonography
3
Description
Mean right CIMT
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Sonography
4
Description
Maximum right CIMT
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: 250 mg carnitine (Avecina, Tehran, Iran), once a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
81151-87159
Phone
+98 36 1534 3570
Fax
Email
asemi_z@kaums.ac.ir
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
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
وحید رضا استاد محمدی
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5556 0608
Email
ostadmohammadi-vr@kaums.ac.ir
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