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Clinical trial of the effect of multi mineral-vitamin D supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome

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History
# Registration date Revision Id
2 2019-09-22, 1398/06/31 104604
1 2017-01-22, 1395/11/03 6133
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of multi mineral-vitamin D supplementation on metabolic 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 Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive multi mineral-vitamin D (n=30) or placebo (n=30). Multi mineral-vitamin D 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: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری مولتی مینرال-ویتامین D بر پروفایل های متابولیک 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 کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مولتی مینرال-ویتامین D (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های مولتی مینرال-ویتامین D 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: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (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 multi mineral-vitamin D supplementation on metabolic profiles in patients of polycystic ovary syndrome (PCOS).
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    هدف این مطالعه تعیین اثرات مکمل یاری مولتی مینرال-ویتامین D بر پروفایل های متابولیک در بیماران مبتلا به سندروم تخمدان پلی کیستیک است.
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    Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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    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.
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    Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak 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 کوثر وابسته به دانشگاه علوم پزشکی اراک، 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 aged 18 to 40 years. Exclusion criteria: Intake of magnesium, zinc, calcium and/or vitamin D supplements within the past 3 months, pregnant women, metabolic disorders, including hyperandrogenism, Cushing’s syndrome, androgen secreting tumors, hyperprolactinemia, thyroid dysfunction and not residing in Arak area.
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    معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: مصرف مکمل های منیزیوم، روی، کلسیم و ویتامین D در 3 ماه گذشته، زنان باردار، اختلالات متابولیک از جمله هایپراندروژنیسم، سندرم کوشینگ، و تولید آندروژن تومورها، هیپرپرولاکتینمی، اختلال عملکرد تیروئید و ساکن اراک نبودن.
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    Intervention: Patients will be assigned into two groups to receive multi mineral-vitamin D (n=30) or placebo (n=30). Multi mineral-vitamin D and placebos capsules are similar in shape and size.
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    مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مولتی مینرال-ویتامین D (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های مولتی مینرال-ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند.
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    Outcomes: Markers of insulin metabolism and hormonal profiles (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
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    پيامدها: مارکرهای متابولیسم انسولین و پروفایل های هورمونی (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

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    2017-02-11, 1395/11/23
    2017-02-01, 1395/11/13
    Patients with PCOS according to Rotterdam criteria
    Aged 18 to 40 years
    بیماران مبتلا به سندروم تخمدان پلی کیستیک بر اساس معیار روتردام
    در محدوده سنی 18 تا 40 سال
    Intake of magnesium, zinc, calcium and/or vitamin D supplementswithin the past 3 months.
    Pregnant women
    Metabolic disorders, including hyperandrogenism, Cushing’s syndrome, androgen secreting tumors, hyperprolactinemia.
    Thyroid dysfunction
    Not residing in Arak area
    مصرف مکمل های منیزیوم، روی، کلسیم و ویتامین D در 3 ماه گذشته.
    زنان باردار
    اختلالات متابولیک، از جمله هایپراندروژنیسم، سندرم کوشینگ، و تولید آندروژن تومورها، هیپرپرولاکتینمی.
    اختلال عملکرد تیروئید
    ساکن اراک نبودن
    Randomization will be done by the use of computer-generated random numbers.
    تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Randomization will be done by the use of computer-generated random numbers.
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    تصادفی سازی با استفاده ازجدول 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.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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  • Primary outcomes

    #1
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    Fasting plasma glucose
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    قند خون ناشتا
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    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
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    Enzymatic kit
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    کیت آنزیمی
    #2
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    Total testosterone
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    توتال تستوسترون
    empty
    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
    empty
    Elisa kit
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    کیت الایزا
    #3
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    SHBG
    empty
    SHBG
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
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    کیت الایزا

  • Secondary outcomes

    #1
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    VLDL
    empty
    VLDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #2
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    LDL
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    LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #3
    empty
    Malondialdehyde
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    مالون دی آلدئید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
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    اسپکتروفتومتری
    #4
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    Hirsutism
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    Hirsutism
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    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
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    Clinical observation
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    مشاهده بالینی

  • Intervention groups

    #1
    Intervention group: Multi mineral-vitamin D supplements (Vitane, Wolfratshausen, Germany), 800 mg calcium, 200 mg magnesium, 8 mg zinc, 400 IU vitamin D3, daily, for 12 weeks orally.
    Intervention group: Multi mineral-vitamin D supplements (Vitane, Wolfratshausen, Germany), 400 mg calcium, 100 mg magnesium, 4 mg zinc, 200 IU vitamin D3, daily, for 12 weeks orally.
    گروه مداخله: مکمل مولتی مینرال-ویتامین D (ویتانه، ولفراشاسن، آلمان)، 800 میلی گرم کلسیم، 200 میلی گرم منیزیم، 8 میلی گرم روی، 400 واحد ویتامین D3، روزانه، به صورت خوراکی برای 12 هفته.
    گروه مداخله: مکمل مولتی مینرال-ویتامین D (ویتانه، ولفراشاسن، آلمان)، 400 میلی گرم کلسیم، 100 میلی گرم منیزیم، 4 میلی گرم روی، 200 واحد ویتامین D3، روزانه، به صورت خوراکی برای 12 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Kosar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Maryam Maktabi
    Full name of responsible person - Persian: مریم مکتبی
    Street address - English: Emam Khomeyni Avenue, Arak
    Street address - Persian: اراک، خیابان امام خمینی
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kosar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Maryam Maktabi
    Full name of responsible person - Persian: مریم مکتبی
    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: 3814113634
    Phone: +98 86 3223 3823
    Fax:
    Email: maktabi.m@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
    Street address - Persian: اراك، 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: Vice chancellor for research, Arak University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
    Street address - Persian: اراك، 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: 3814113634
    Phone: +98 86 3223 3823
    Fax:
    Email: rafiee-m@aums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
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    Street address - English:
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    contact.provinces_available:
    Country:
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    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: 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_z@kaums.ac.ir
    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: 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: 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:

  • 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: ذ ات 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: 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: 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:

  • Sharing plan

    undecided
    undecided
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    undecided
    undecided
    undecided
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    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.

Protocol summary

Study aim
The aim of this study is to determine the effects of multi mineral-vitamin D supplementation on metabolic profiles in patients of polycystic ovary syndrome (PCOS).
Design
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 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 aged 18 to 40 years. Exclusion criteria: Intake of magnesium, zinc, calcium and/or vitamin D supplements within the past 3 months, pregnant women, metabolic disorders, including hyperandrogenism, Cushing’s syndrome, androgen secreting tumors, hyperprolactinemia, thyroid dysfunction and not residing in Arak area.
Intervention groups
Intervention: Patients will be assigned into two groups to receive multi mineral-vitamin D (n=30) or placebo (n=30). Multi mineral-vitamin D and placebos capsules are similar in shape and size.
Main outcome variables
Outcomes: Markers of insulin metabolism and hormonal profiles (primary outcomes) and lipid profiles, biomarkers of inflammation and 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: IRCT201701165623N103
Registration date: 2017-01-22, 1395/11/03
Registration timing: registered_while_recruiting

Last update: 2019-09-22, 1398/06/31
Update count: 1
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-01-12, 1395/10/23
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Clinical trial of the effect of multi mineral-vitamin D 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:
Patients with PCOS according to Rotterdam criteria Aged 18 to 40 years
Exclusion criteria:
Intake of magnesium, zinc, calcium and/or vitamin D supplementswithin the past 3 months. Pregnant women Metabolic disorders, including hyperandrogenism, Cushing’s syndrome, androgen secreting tumors, hyperprolactinemia. Thyroid dysfunction Not residing in Arak area
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
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
Ethics committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
IR.ARAKMU.REC.1395.325

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovary syndrome

Primary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

3

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

5

Description
SHBG
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

Secondary outcomes

1

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

8

Description
VLDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

9

Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

10

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

11

Description
Hirsutism
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Clinical observation

Intervention groups

1

Description
Intervention group: Multi mineral-vitamin D supplements (Vitane, Wolfratshausen, Germany), 400 mg calcium, 100 mg magnesium, 4 mg zinc, 200 IU vitamin D3, daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule, daily for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Maryam Maktabi
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
maktabi.m@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
rafiee-m@aums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
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
Email
asemi_z@kaums.ac.ir

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_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
81151-87159
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
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