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Effect of zinc supplementation on insulin resistance and lipid profiles in women with gestational diabetes

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History
# Registration date Revision Id
3 2020-10-04, 1399/07/13 154490
2 2019-09-25, 1398/07/03 110550
1 2014-09-05, 1393/06/14 6056
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of zinc supplementation on insulin resistance and lipid profiles in gestational diabetes. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either zinc supplement (intervention group) or placebo (control group). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles. Start and End Date of Intervention: 6 weeks (August 1, 2014-September 15, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, triglycerides, cholesterol and HDL-cholesterol levels.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روی بر مقاومت به انسولین و پروفایل های لیپیدی در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آنهایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل روی (گروه مداخله) یا پلاسبو (گروه کنترل) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته (از 10 مرداد 1393 تا 15 شهریور 1393). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، تری گلیسرید، کلسترول و HDL در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of zinc supplementation on insulin resistance and lipid profiles in gestational diabetes.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روی بر مقاومت به انسولین و پروفایل های لیپیدی در دیابت بارداری است.
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    Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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    طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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    Population and sample size: 58 patients with gestational diabetes mellitus among pregnant women of eligible and referred to Kosar Gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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    حجم نمونه و جمعیت مورد مطالعه: 58 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک زنان کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with gestational diabetes mellitus at 24-28 weeks' gestation. Exclusion Criteria: Taking zinc supplements, premature preterm rupture of membrane, placenta abruption, pre-eclampsia, eclampsia, hypo- and hypothyroidism.
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    معیارهای ورود مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری در هفته 28-24 بارداری. معیارهای خروج مطالعه: گرفتن مکمل روی، پارگی زودرس غشاء، جدا شدن زودرس جفت، پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید.
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    Intervention group: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally. Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day for 6 weeks orally.
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    گروه مداخله: کپسول روی (شرکت دارویی دنیای بهشت، تهران، ایران)، 30 میلی گرم، روزانه یک عدد به صورت خوراکی برای 6 هفته. گروه کنترل: کپسول پلاسبو (شرکت دارویی باریج اسانس، کاشان، ایران)، روزانه یک عدد به صورت خوراکی برای 6 هفته.
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    Outcomes: Insulin and insulin resistance (primary outcomes). Fasting plasma glucose and lipid profiles (secondary outcome).
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    پيامدها: انسولین و مقاومت به انسولین (پیامدهای اولیه). قند پلاسمایی ناشتا و پروفایل های لیپیدی (پیامدهای ثانویه).

  • General information

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    60
    58
    2014-07-23, 1393/05/01
    2014-08-04, 1393/05/13
    2014-08-06, 1393/05/15
    2014-08-18, 1393/05/27
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    Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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    بواسطه کم توجهی، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شده است. اگرچه، اصلاحات صورت گرفته مطابق با یا پروپوزال اصلی تصویب شده یا با هماهنگی معاونت پژوهشی دانشگاه بود.
    Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with gestational diabetes mellitus at 24-28 weeks' gestation
    زنان باردار 40-18 ساله مبتلا به دیابت بارداری در هفته 28-24 بارداری
    Taking zinc supplements
    Premature preterm rupture of membrane
    Placenta abruption
    Pre-eclampsia
    Eclampsia
    Chronic hypo- and hypothyroidism
    گرفتن مکمل روی
    پارگی زودرس غشاء
    جدا شدن زودرس جفت
    پره اکلامپسی
    اکلامپسی
    کم کاری و پرکاری تیروئید
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    At study baseline after balanced blocked randomisation, participants will be allocated into two treatment groups to take either zinc supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups.
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    در ابتدای مطالعه بعد از تصادفی سازی بلوکی بالانس شده، افراد به دو گروه برای دریافت مکمل روی (n=29) یا پلاسبو (n=29) تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار Stat Trek انجام می شود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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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 Clinic who is not involved in the trial and not aware of random sequences will allocate the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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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 که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، بطری های شماره گذاری شده کپسول ها را به شرکت کنندگان تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود. بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود.
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  • Primary outcomes

    #1
    Fasting plasma glucose
    Insulin
    قند خون ناشتا
    انسولین
    Baseline and End-of-trial
    At the beginning of the study and after 6 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Enzymatic
    Eliza
    آنزیمی
    الایزا
    #2
    Insulin
    Insulin resistance
    انسولین
    مقاومت به انسولین
    Baseline and End-of-trial
    At the beginning of the study and after 6 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    Eliza
    Calculation with HOMA formula
    الایزا
    محاسبه با فرمول HOMA
    #3
    Triglyceride
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #4
    Cholesterol
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    کلسترول
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #5
    HDL-cholesterol
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    کلسترول HDL
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic
    empty
    آنزیمی
    empty

  • Secondary outcomes

    #1
    empty
    Fasting blood sugar
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    قند خون ناشتا
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #2
    empty
    Triglycerides
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    تری گلیسرید
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #3
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
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    VLDL-cholesterol
    empty
    کلسترول VLDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    LDL-cholesterol
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    کلسترول LDL
    empty
    At the beginning of the study and after 6 weeks of intervention
    empty
    در ابتدای مطالعه و 6 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی

  • Intervention groups

    #1
    Intervention group: Zinc capsule, 30 mg, daily for 6 weeks orally.
    Intervention group: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally.
    گروه مداخله: کپسول روی، 30 میلی گرم، روزانه به صورت خوراکی برای 6 هفته.
    گروه مداخله: کپسول روی (شرکت دارویی دنیای بهشت، تهران، ایران)، 30 میلی گرم، روزانه یک عدد به صورت خوراکی برای 6 هفته.
    #2
    Control group: Placebo capsule, daily for 6 weeks orally.
    Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day for 6 weeks orally.
    گروه کنترل: کپسول پلاسبو، روزانه به صورت خوراکی برای 6 هفته.
    گروه کنترل: کپسول پلاسبو (شرکت دارویی باریج اسانس، کاشان، ایران)، روزانه یک عدد به صورت خوراکی برای 6 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Kossar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    Street address - English:
    Street address - Persian:
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kosar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    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: karamali.maryam2@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Arak University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اراک
    Full name of responsible person - English: Mohammad Rafiee
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3814113634
    Phone: +98 86 3223 3823
    Fax:
    Email: research@aums.ac.ir
    Web page address:
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    Public
    empty
    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:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1771844351
    Phone: +98 31 5546 3378
    Mobile: 009133615446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: Nutrition PhD
    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: Bolvare Ghotbe Ravandi, 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.irasemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: Nutrition PhD
    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: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Science
    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: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    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
Objective: The aim of this study is to determine the effects of zinc supplementation on insulin resistance and lipid profiles in gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 58 patients with gestational diabetes mellitus among pregnant women of eligible and referred to Kosar Gynecology Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with gestational diabetes mellitus at 24-28 weeks' gestation. Exclusion Criteria: Taking zinc supplements, premature preterm rupture of membrane, placenta abruption, pre-eclampsia, eclampsia, hypo- and hypothyroidism.
Intervention groups
Intervention group: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally. Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day for 6 weeks orally.
Main outcome variables
Outcomes: Insulin and insulin resistance (primary outcomes). Fasting plasma glucose and lipid profiles (secondary outcome).

General information

Reason for update
Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number: IRCT201408295623N26
Registration date: 2014-09-05, 1393/06/14
Registration timing: retrospective

Last update: 2019-11-09, 1398/08/18
Update count: 2
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-08-04, 1393/05/13
Expected recruitment end date
2014-08-18, 1393/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on insulin resistance and lipid profiles in women with gestational diabetes
Public title
Effect of zinc in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: Pregnant women aged 18-40 years diagnosed with gestational diabetes mellitus at 24-28 weeks' gestation
Exclusion criteria:
Taking zinc supplements Premature preterm rupture of membrane Placenta abruption Pre-eclampsia Eclampsia Chronic hypo- and hypothyroidism
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: 58
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline after balanced blocked randomisation, participants will be allocated into two treatment groups to take either zinc supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups.
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 Clinic who is not involved in the trial and not aware of random sequences will allocate the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
93-165-2

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Eliza

2

Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation with HOMA formula

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Zinc capsule (Donyayeh Behesht Pharmaceutical Company, Tehran, Iran), 30 mg, once a day for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule (Barij Essence Pharmaceutical Company, Kashan, Iran), once a day for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Maryam Karamali
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
karamali.maryam2@gmail.com

Sponsors / Funding sources

1

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

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
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_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Science
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_r@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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