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The effect of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1)

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History
# Registration date Revision Id
2 2019-09-20, 1398/06/29 109431
1 2014-12-19, 1393/09/28 6060
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-55 years diagnosed with CIN1 will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 women with CIN1 eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplement (intervention group: n=30) or placebo (control group: n=30) every 2 weeks. Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles and inflammatory factor. Start and End Date of Intervention: 6 months (August 5, 2014-Februray 4, 2015). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر روی درمان، پروفایل های متابولیک و پروتئین واکنشگر C با حساسیت بالا در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: زنان 55-18 ساله مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 در این مطالعه وارد خواهند شد. افراد مبتلا به نئوپلاستیک، اختلالات قلبی-عروقی، اختلالات سوء جذبی، استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون، داروهای ضد دیابتیک و داروهای ضد چاقی از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل 50000 واحد ویتامین D (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) هر دو هفته یک بار تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 ماه بعد از مداخله برای تعیین پروفایل های متابولیک و فاکتور التهابی از بیماران گرفته خواهد شد. زمان مداخله: 6 ماه (از 14 مرداد 1393 تا 15 بهمن 1393). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و hs-CRP، 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 vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1).
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر روی درمان، پروفایل های متابولیک و پروتئین واکنشگر C با حساسیت بالا در زنان مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 است.
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    In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
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    در این مطالعه کارآزمایی بالینی دو سوکور کنترل شده با دارونما، بیماران به دو گروه برای دریافت مکمل یاری ویتامین دی یا پلاسبو اختصاص داده خواهند شد.
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    58 women with cervical intraepithelial neoplasia 1 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    58 زن مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 واجد شرایط و ارجاع شده به کلینیک انکولوژی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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    Patients aged between 18 and 55 years with cervical intraepithelial neoplasia 1will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
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    بیماران مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1 در سنین 18 تا 55 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه به شرح زیر خواهد بود: زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی تحتانی ، سابقه هیسترکتومی یا درمان تهاجمی گردن رحم داشته باشند و زنان باردار
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    Intervention group: Vitamin D pearl, 50000 IU (Zahravi, Tabriz, Iran), every 2 weeks, for 6 months orally. Control group: Placebo pearl (Barij Essence, Kashan, Iran), every 2 weeks, for 6 months orally.
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    گروه مداخله: پرل ویتامین دی، 50000 واحد، (زهراوی، تبریز، ایران) هر دو هفته یک بار، به صورت خوراکی برای 6 ماه. گروه کنترل: پرل پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته یک بار، به صورت خوراکی برای 6 ماه.
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    Fasting plasma glucose (FPG), serum levels of insulin, lipid profiles and hs-CRP.
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    گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، پروفایل های لیپیدی و hs-CRP

  • General information

    1
    1
    1
    N/A
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    60
    58
    2004-07-04, 1383/04/14
    2014-08-06, 1393/05/15
    2014-08-05, 1393/05/14
    2014-08-27, 1393/06/05
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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.
    Women aged 18-55 years
    Diagnosed with cervical intraepithelial neoplasia 1
    زنان 55-18 ساله
    مبتلا به نئوپلازی داخل اپی تلیالی سرویکس درجه 1
    Women who had a history of cervical cancer or other cancers of the lower genital tract
    History of hysterectomy or destructive therapy of the cervix
    Pregnant women
    زنانی که سابقه سرطان دهانه رحم یا سایر سرطانهای دستگاه تناسلی داشتند
    سابقه هیسترکتومی یا درمان تهاجمی گردن رحم
    زنان باردار
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    At study baseline and after stratification for pre-intervention BMI and age, participants in each block will be randomly allocated into two treatment groups to take either vitamin D 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. https://stattrek.com/statistics/random-number-generator.aspx
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل ویتامین دی (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. https://stattrek.com/statistics/random-number-generator.aspx
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi outpatient 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 Barij Essence 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 سرپایی نقوی 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 باریج اسانس 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
    Cervical intraepithelial neoplasia grade
    قند خون ناشتا
    گرید نئوپلازی داخل اپی تلیالی سرویکس
    Enzymatic
    Colposcopic
    آنزیمی
    کولپوسکوپیک
    #2
    Triglycerides
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    تری گلیسرید
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Enzymatic
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    آنزیمی
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    #3
    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی توتال
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
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    اسپکتروفتومتری
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    #4
    Cholesterol
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    کلسترول
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    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #5
    Glutathione
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    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
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    اسپکتروفتومتری
    empty
    #6
    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Elisa
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    الایزا
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  • Secondary outcomes

    #1
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    Insulin
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    انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Elisa kit
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    کیت الایزا
    #2
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    Insulin resistance
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    مقاومت به انسولین
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Calculation using HOMA formula
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    محاسبه با استفاده از فرمول HOMA
    #3
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    Total cholesterol
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    توتال کلسترول
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
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    Triglycerides
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    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
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    HDL
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    HDL
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    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    High-sensitivity C-reactive Protein
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa kit
    empty
    کیت الایزا
    #7
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    Nitric oxide
    empty
    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #8
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #9
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #10
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    Malondialdehyde
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    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #11
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    Fasting blood sugar
    empty
    قند خون ناشتا
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #12
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    Serum vitamin D
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    ویتامین دی سرمی
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
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    Elisa kit
    empty
    کیت الایزا

  • Intervention groups

    #1
    Intervention group: Vitamin D pearl, 50000 IU, every 2 weeks, for 6 months orally.
    Intervention group: Vitamin D pearl, 50000 IU (Zahravi, Tabriz, Iran), every 2 weeks, for 6 months orally.
    گروه مداخله: پرل ویتامین D، 50000 واحد، هر دو هفته یک بار، به صورت خوراکی برای 6 ماه.
    گروه مداخله: پرل ویتامین دی، 50000 واحد، (زهراوی، تبریز، ایران) هر دو هفته یک بار، به صورت خوراکی برای 6 ماه.
    #2
    Control group: Placebo pearl, every 2 weeks, for 6 months orally.
    Control group: Placebo pearl (Barij Essence, Kashan, Iran), every 2 weeks, for 6 months orally.
    گروه کنترل: پرل پلاسبو، هر دو هفته یک بار، به صورت خوراکی برای 6 ماه.
    گروه کنترل: پرل پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته یک بار، به صورت خوراکی برای 6 ماه.

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    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 outpatient Clinic
    Name of recruitment center - Persian: کلینیک سرپایی نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: 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
    Street address - English: Bolvare Ghotbe Ravandi, 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: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Bolvare Ghotbe Ravandi, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: hamidi-gh@kaums.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:
    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:

    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: 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: Bolvare Ghotbe Ravandi, 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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: 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: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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: +98
    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 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: 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: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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: 8115187159
    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 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:
    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: Kashan
    City - Persian: Kashan
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: +98
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: 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: Bolvare Ghotbe Ravandi, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: Kashan
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    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
    empty
    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.

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1).
Design
In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
Settings and conduct
58 women with cervical intraepithelial neoplasia 1 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients aged between 18 and 55 years with cervical intraepithelial neoplasia 1will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
Intervention groups
Intervention group: Vitamin D pearl, 50000 IU (Zahravi, Tabriz, Iran), every 2 weeks, for 6 months orally. Control group: Placebo pearl (Barij Essence, Kashan, Iran), every 2 weeks, for 6 months orally.
Main outcome variables
Fasting plasma glucose (FPG), serum levels of insulin, lipid profiles and hs-CRP.

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: IRCT201412065623N30
Registration date: 2014-12-19, 1393/09/28
Registration timing: retrospective

Last update: 2019-10-30, 1398/08/08
Update count: 1
Registration date
2014-12-19, 1393/09/28
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
Kashan University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2014-08-27, 1393/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1)
Public title
Effect of supplementation in treatment of cervical intraepithelial neoplasia 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-55 years Diagnosed with cervical intraepithelial neoplasia 1
Exclusion criteria:
Women who had a history of cervical cancer or other cancers of the lower genital tract History of hysterectomy or destructive therapy of the cervix Pregnant women
Age
From 18 years old to 55 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 and after stratification for pre-intervention BMI and age, participants in each block will be randomly allocated into two treatment groups to take either vitamin D 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. https://stattrek.com/statistics/random-number-generator.aspx
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi outpatient 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 Barij Essence 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
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2014-08-05, 1393/05/14
Ethics committee reference number
29/5/1/4229/پ

Health conditions studied

1

Description of health condition studied
Cervical intraepithelial neoplasia 1(CIN1)
ICD-10 code
C53.9
ICD-10 code description
Cervix uteri, unspecified

Primary outcomes

1

Description
Cervical intraepithelial neoplasia grade
Timepoint
Baseline and End-of-trial
Method of measurement
Colposcopic

Secondary outcomes

1

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

2

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using HOMA formula

3

Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

4

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

5

Description
HDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

6

Description
High-sensitivity C-reactive Protein
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

7

Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

8

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

9

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

10

Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

11

Description
Fasting blood sugar
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

12

Description
Serum vitamin D
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa kit

Intervention groups

1

Description
Intervention group: Vitamin D pearl, 50000 IU (Zahravi, Tabriz, Iran), every 2 weeks, for 6 months orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo pearl (Barij Essence, Kashan, Iran), every 2 weeks, for 6 months orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi outpatient Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
hamidi-gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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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