Clinical trial of the effect of combined magnesium and zinc supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
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Protocol summary
Objective: The aim of this study is to determine the effects of combined magnesium and zinc supplementation on metabolic and genetic profiles in patients of polycystic ovary syndrome (PCOS). 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 PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with PCOS 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 into two groups to receive combined magnesium and zinc (n=30) or placebo (n=30). Combined magnesium and zinc, and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 3 months. Outcomes: Hormonal profiles (primary outcomes) and biomarkers of inflammation, oxidative stress and genetic (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 combined magnesium and zinc supplementation on metabolic and genetic profiles in patients of polycystic ovary syndrome (PCOS). 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 PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with PCOS 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 into two groups to receive combined magnesium and zinc (n=30) or placebo (n=30). Combined magnesium and zinc, and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 3 months. Outcomes: Hormonal profiles (primary outcomes) and biomarkers of inflammation, oxidative stress and genetic (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و روی بر پروفایل های متابولیک و ژنتیک 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 بر اساس معیار روتردام 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 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 به دو گروه برای دریافت ترکیب منیزیم و روی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ترکیب منیزیم و روی 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: 3 ماه. پيامدها: پروفایل های هورمونی (پیامدهای اولیه) و بیومارکرهای التهاب، استرس اکسیداتیو و ژنتیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و روی بر پروفایل های متابولیک و ژنتیک 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 بر اساس معیار روتردام 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 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 به دو گروه برای دریافت ترکیب منیزیم و روی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ترکیب منیزیم و روی 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: 3 ماه. پيامدها: پروفایل های هورمونی (پیامدهای اولیه) و بیومارکرهای التهاب، استرس اکسیداتیو و ژنتیک (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 combined magnesium and zinc supplementation on metabolic and genetic profiles in patients of polycystic ovary syndrome (PCOS).
The aim of this study is to determine the effects of combined magnesium and zinc supplementation on metabolic and genetic profiles in patients of polycystic ovary syndrome (PCOS).
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هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و روی بر پروفایل های متابولیک و ژنتیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و روی بر پروفایل های متابولیک و ژنتیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
کارآزمایی بالینی تصادفي، دو سوکور ، موازی، 60 نفر، فاز 3
کارآزمایی بالینی تصادفي، دو سوکور ، موازی، 60 نفر، فاز 3
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Population and sample size: Among patients with PCOS referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Population and sample size: Among patients with PCOS 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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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.
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.
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18–40 years old will be included in this study. Exclusion criteria: Pregnant during the intervention, metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes, insulin injection and taking anti-inflammatory drugs
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18–40 years old will be included in this study. Exclusion criteria: Pregnant during the intervention, metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes, insulin injection and taking anti-inflammatory drugs
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معیار ورود به مطالعه: بیماران مبتلا به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: حاملگی در حین مداخله، اختلالات متابولیکی ازجمله تومورهای ترشح آندروژن، اختلال عملکرد تیروئید، دیابت، تزریق انسولین و مصرف داروهای ضدالتهابی.
معیار ورود به مطالعه: بیماران مبتلا به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: حاملگی در حین مداخله، اختلالات متابولیکی ازجمله تومورهای ترشح آندروژن، اختلال عملکرد تیروئید، دیابت، تزریق انسولین و مصرف داروهای ضدالتهابی.
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Patients will be assigned into two groups to receive combined magnesium and zinc (n=30) or placebo (n=30). Combined magnesium and zinc, and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 3 months.
Patients will be assigned into two groups to receive combined magnesium and zinc (n=30) or placebo (n=30). Combined magnesium and zinc, and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 3 months.
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بیماران به دو گروه برای دریافت ترکیب منیزیم و روی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ترکیب منیزیم و روی و پلاسبو از نظر شکل و اندازه مشابه هستند. زمان مداخله: 3 ماه.
بیماران به دو گروه برای دریافت ترکیب منیزیم و روی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های ترکیب منیزیم و روی و پلاسبو از نظر شکل و اندازه مشابه هستند. زمان مداخله: 3 ماه.
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Inflammatory markers (primary outcome) and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
Inflammatory markers (primary outcome) and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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مارکرهای التهابی (پیامد اولیه) و بیومارکرهای استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
مارکرهای التهابی (پیامد اولیه) و بیومارکرهای استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2016-05-31, 1395/03/11
2017-06-01, 1396/03/11
20162017-0506-3101 00:00:00
2016-06-10, 1395/03/21
2017-06-06, 1396/03/16
20162017-06-1006 00:00:00
Aged 18–40 years old
Patients with PCOS according to Rotterdam criteria
Aged 18–40 years old Patients with PCOS according to Rotterdam criteria
محدوده سنی 18 تا 40 سال
بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
محدوده سنی 18 تا 40 سال بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
Pregnant during the intervention
Metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes
insulin injection
Taking anti-inflammatory drugs
Pregnant during the intervention Metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes insulin injection Taking anti-inflammatory drugs
Randomization will be done by the use of computer-generated random numbers.
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Randomization will be done by the use of computer-generated random numbers.ظ
تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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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 either combined magnesium and zinc supplementation (n=30) or placebo (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 either combined magnesium and zinc supplementation (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 طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل یاری ترکیب منیزیم و روی (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 طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل یاری ترکیب منیزیم و روی (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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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
Total testosterone
Hs-CRP
Total testosteroneHs-CRP
توتال تستوسترون
پروتئین واکنشگر C با حساسیت بالا
توتال تستوسترونپروتئین واکنشگر C با حساسیت بالا
#2
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Expressed levels of IL-1 gene
Expressed levels of IL-1 gene
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سطوح بیان IL-1
سطوح بیان IL-1
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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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
empty
Expressed levels of IL-8 gene
Expressed levels of IL-8 gene
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سطوح بیان IL-8
سطوح بیان IL-8
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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PCR
PCR
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PCR
PCR
#4
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Expressed levels of TNF-a gene
Expressed levels of TNF-a gene
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سطوح بیان TNF-a
سطوح بیان TNF-a
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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
Secondary outcomes
#1
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#2
Malondialdehyde
Glutathione
MalondialdehydeGlutathione
مالون دی آلدئید
گلوتاتیون
مالون دی آلدئیدگلوتاتیون
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#3
Glutathione
Nitric oxide
GlutathioneNitric oxide
گلوتاتیون
نیتریک اکساید
گلوتاتیوننیتریک اکساید
اسکتروفتومتری
اسپکتروفتومتری
اسکتروفتومتریاسپکتروفتومتری
#4
Hs-CRP
Expressed levels of TGF-β gene
HsExpressed levels of TGF-CRPβ gene
پروتئین واکنشگر C با حساسیت بالا
سطوح بیان TGF-β
پروتئین واکنشگر C با حساسیت بالاسطوح بیان TGF-β
Elisa kit
PCR
Elisa kitPCR
کیت الایزا
PCR
کیت الایزاPCR
#5
Expressed levels of LL-1 gene
Expressed levels of VEGF gene
Expressed levels of LL-1VEGF gene
سطوح بیان IL-1
سطوح بیان VEGF
سطوح بیان IL-1VEGF
#6
Expressed levels of IL-8 gene
Malondialdehyde
Expressed levels of IL-8 geneMalondialdehyde
سطوح بیان IL-8
مالون دی آلدئید
سطوح بیان IL-8مالون دی آلدئید
PCR
Spectrophotometry
PCRSpectrophotometry
PCR
اسپکتروفتومتری
PCRاسپکتروفتومتری
#7
Expressed levels of TNF-a gene
Protein carbonyl
Expressed levels of TNF-a geneProtein carbonyl
سطوح بیان TNF-a
پروتئین کربونیل
سطوح بیان TNF-aپروتئین کربونیل
PCR
Spectrophotometry
PCRSpectrophotometry
PCR
اسپکتروفتومتری
PCRاسپکتروفتومتری
Recruitment centers
#1
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: Ghotbe Ravandi Boulevard, 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: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: asemi_z@kaums.ac.ir
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: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Fax: Email: asemi_z@kaums.ac.ir 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:
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: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: Gholamali_h@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: 1771844351 Phone: +98 31 5546 3378 Fax: Email: Gholamali_h@kaums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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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: 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: 00
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: 1771844351
Phone: +98 31 5546 3378
Mobile: 009133615446
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: 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: 1771844351 Phone: +98 31 5546 3378 Mobile: 00009133615446 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: 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: 00
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: 1771844351
Phone: +98 31 5546 3378
Mobile: 009133615446
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: 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: 1771844351 Phone: +98 31 5546 3378 Mobile: 00009133615446 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: 00
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: 1771844351
Phone: +98 31 5546 3378
Mobile: 00
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: 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: 1771844351 Phone: +98 31 5546 3378 Mobile: 00 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of combined magnesium and zinc supplementation on metabolic and genetic profiles in patients of polycystic ovary syndrome (PCOS).
Population and sample size: Among patients with PCOS 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
Inclusion criteria: Patients with PCOS according to Rotterdam criteria and aged 18–40 years old will be included in this study. Exclusion criteria: Pregnant during the intervention, metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes, insulin injection and taking anti-inflammatory drugs
Intervention groups
Patients will be assigned into two groups to receive combined magnesium and zinc (n=30) or placebo (n=30). Combined magnesium and zinc, and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 3 months.
Main outcome variables
Inflammatory markers (primary outcome) and biomarkers of oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201706075623N121
Registration date:2017-06-11, 1396/03/21
Registration timing:retrospective
Last update:2019-09-21, 1398/06/30
Update count:1
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2017-06-06, 1396/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined magnesium and zinc supplementation compared with the placebo on metabolic profiles 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:
Aged 18–40 years old
Patients with PCOS according to Rotterdam criteria
Exclusion criteria:
Pregnant during the intervention
Metabolic disorders, including androgen-secreting tumors, thyroid dysfunction, diabetes
insulin injection
Taking anti-inflammatory drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
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 either combined magnesium and zinc supplementation (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
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
ظ
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
1771844351
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.Kaums.REC.1396.44
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary 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
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
4
Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Protein carbonyl
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 magnesium (21st Century, Arizona, USA) and 220 mg zinc daily (Alhavi, Isfahan, Iran), for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule daily (Barij Essence, Kashan, Iran), 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
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
Gholamali_h@kaums.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, 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
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
1771844351
Phone
+98 31 5546 3378
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
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
1771844351
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
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
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
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