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Effects of calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia

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History
# Registration date Revision Id
2 2021-05-26, 1400/03/05 184091
1 2015-01-31, 1393/11/11 5844
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  • Protocol summary

    Objective: This study is to determine the effects of vitamin D on metabolic profiles, hs-CRP and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia. Study design: Randomized double-blind controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women, primigravida, aged 18-40 year old at 20 weeks' gestation with positive screening tests will be included in this study. Multiparous women as well as those with hypertension, gestational diabetes mellitus (GDM), 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 pregnant women of 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/each 2 weeks and 1000 mg calcium daily (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (September 7, 2014- December 7, 2014).
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    هدف: این مطالعه تعیین اثرات ویتامین D بر روی پروفایل های متابولیک، پروتئین واکنشگر C و بیومارکرهای استرس اکسیداتیو در زنان باردار در معرض خطر پری اکلامپسی است. طراحی مطالعه: تصادفي، کارآزمایی بالینی کنترل شده دو سوکور. معیار ورود و خروج مطالعه: زنان باردار، با بارداری اول، 40-18 ساله که تک قلو باردار هستند در هفته 20 بارداری با تست های غربالگری مثبت وارد مطالعه خواهند شد. زنان باردار چند قلو و همچنين آن هایی که مبتلا به فشار خون، دیابت بارداری، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار واجد شرایط و ارجاع شده به کلینیک نقوي وابسته به دانشگاه علوم پزشکی كاشان،كاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت 50000 واحد ویتامین D هر دو هفته یک بار و 1000 ميلي گرم كلسيم روزانه (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله برای تعیین پروفایل های متابولیک و بیومارکرهای استرس اکسیداتیو از بیماران گرفته خواهد شد. زمان مداخله: 12هفته (از 16شهريور 1393 تا 16آذر 1393).
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    This study is to determine the effects of vitamin D on metabolic profiles, hs-CRP and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia.
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    این مطالعه تعیین اثرات ویتامین D بر روی پروفایل های متابولیک، پروتئین واکنشگر C و بیومارکرهای استرس اکسیداتیو در زنان باردار در معرض خطر پره اکلامپسی است.
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    Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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    طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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    Sixty pregnant women of eligible and referred to Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    شصت زن باردار واجد شرایط و ارجاع شده به کلینیک وابسته به دانشگاه علوم پزشکی كاشان،كاشان، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Primigravida pregnant women; aged 18–40 years old; at risk for pre-eclampsia; lived approximately 20 km or less from the clinic and hospital. Exclusion criteria: Hypertension; renal diseases; gestational diabetes mellitus (GDM); abnormal foetal anomaly scan
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    معیار ورود مطالعه: زنان باردار با بارداری اول؛ 40-18 ساله؛ در معرض خطر پره اکلامپسی؛ زندگی تقریبا 20 کیلومتر یا کمتر از کلینیک و بیمارستان. معیار خروج مطالعه: فشار خون؛ بیماری های کلیه؛ دیابت بارداری؛ اسکن آنومالی جنینی غیرطبیعی.
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    Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks and 1000 mg calcium daily (intervention group: n=30) or placebo (control group: n=30).
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    بیماران برای دریافت 50000 واحد ویتامین D هر دو هفته یک بار و 1000 ميلي گرم كلسيم روزانه (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Pre-eclampsia rate, low birth weight (LBW) (<2500 g), newborn's birth size and preterm delivery (<37 weeks) (primary outcomes) and other metabolic profiles (secondary outcome).
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    پره اکلامپسی، وزن تولد کم (کمتر از 2500 گرم)، سایز تولد نوزادان تازه متولد شده و زایمان زودرس (پیامد اولیه) و سایر پروفایل های متابولیک (پیامدهای ثانویه).

  • General information

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    2014-05-06, 1393/02/16
    2014-09-06, 1393/06/15
    2014-09-07, 1393/06/16
    2014-10-06, 1393/07/14
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    Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were 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.
    Primigravida pregnant women
    Aged 18–40 years old
    At risk for pre-eclampsia
    Lived approximately 20 km or less from the clinic and hospital
    زنان باردار با بارداری اول
    40-18 ساله
    در معرض خطر پره اکلامپسی
    زندگی تقریبا 20 کیلومتر یا کمتر از کلینیک و بیمارستان
    Hypertension
    Renal diseases
    Gestational diabetes mellitus (GDM)
    Abnormal foetal anomaly scan
    فشار خون
    بیماری های کلیه
    دیابت بارداری
    اسکن آنومالی جنینی غیرطبیعی
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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 be allocated 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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    Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
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    بیماران به طور تصادفی به دو گروه تخصیص داده خواهند شد. یک لیست اعداد تصادفی از 1 تا 60 با استفاده از یک سایت تولید کننده اعداد تصادفی (https://stattrek.com/statistics/random-number-generator.aspx) ایجاد خواهد شد و سپس بیماران با استفاده از اعداد به دو گروه مداخله تخصیص داده خواهند شد.
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  • Health conditions studied

    #1
    Pre-eclampcy
    Pre-eclampsia

  • Primary outcomes

    #1
    Total cholesterol
    Pre-eclampsia rate
    کلسترول توتال
    میزان پره اکلامپسی
    Baseline and 12 weeks after the intervention
    After delivery
    ابتدا و 12 هفته بعد از مداخله
    بعد زایمان
    Enzymatic
    Medical record
    آنزيمي
    پرونده پزشکی
    #2
    LDL-cholesterol
    Low birth weight (LBW) (<2500 g)
    کلسترولLDL
    کاهش وزن تولد
    Baseline and 12 weeks after the intervention
    After delivery
    قبل از مداخله و 12 هفته بعد از شروع مداخله
    بعد زایمان
    Enzymatic
    Scale
    آنزیمی
    ترازو
    #3
    Triglycerides
    Newborn's birth size
    تری گلیسرید
    سایز تولد نوزادان تازه متولد شده
    Baseline and 12 weeks after the intervention
    After delivery
    قبل از مداخله و 12 هفته بعد از شروع مطالعه
    بعد زایمان
    Enzymatic
    Scale and tape
    آنزیمی
    ترازو و متر
    #4
    HDL-cholesterol
    Preterm delivery (<37 weeks)
    کلسترولHDL
    زایمان زودرس (کمتر از 37 هفته)
    Baseline and 12 weeks after the intervention
    After delivery
    قبل از مداخله و 12 هفته بعد از شروع مداخله
    بعد زایمان
    Enzymatic
    Medical record
    آنزیمی
    پرونده پزشکی
    #5
    Fasting plasma glucose
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    گلوکز پلاسمایی ناشتا
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    Baseline and 12 weeks after the intervention
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    قبل از مداخله و 12 هفته بعد از شروع مداخله
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    Enzymatic
    empty
    آنزیمی
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    #6
    Plasma total antioxidant capacity
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    توتال آنتی اکسیدان پلاسما
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    Baseline and 12 weeks after the intervention
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    قبل از مداخله و 12 هفته بعد از مداخله
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    Spectrophotometry
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    اسپکتروفتومتری
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    #7
    Total glutathione
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    گلوتاتیون توتال
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    Baseline and 12 weeks after the intervention
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    قبل از مداخله و 12 هفته بعد از مداخله
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    spectrophotometry
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    اسپکتروفتومتری
    empty
    #8
    Serum insulin levels
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    سطوح انسولین سرم
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    Baseline and 12 weeks after the intervention
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    قبل از مداخله و 12 هفته بعد از شروع مداخله
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    Eliza
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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
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    Eliza
    empty
    الایزا
    #2
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    Nitric oxide
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    نیتریک اکساید
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    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #3
    empty
    High-sensitivity C-reactive protein
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Eliza
    empty
    الایزا
    #4
    empty
    Total antioxidant capacity
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    ظرفیت آنتی اکسیدانی توتال
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    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
    empty
    Fasting plasma glucose
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    قند خون ناشتا
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #6
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    Triglyceride
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    تری گلیسرید
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    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #7
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    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #8
    empty
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #9
    empty
    Blood pressures
    empty
    فشارخون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
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    Manometer
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    مانومتر

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Street address - English: Naghavi Hospital
    Street address - Persian: بيمارستان نقوي
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Gynecology Clinic
    Name of recruitment center - Persian: کلینیک زنان
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Street address - English: Shahid Rajaee Street, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: dr_samimi.2007@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان، معاونت پژوهشی
    Full name of responsible person - English: Dr Gholamali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Street address - English: Vice chancellor for research, Ghotbe Ravandi Blvd
    Street address - Persian: بلوار قطب راوندي، معاونت پ‍ژوهشي
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان، معاونت پژوهشی
    Full name of responsible person - English: Dr Gholamali Hamidi
    Full name of responsible person - Persian: دكتر غلامعلي حميدي
    Street address - English: Vice chancellor for research, Ghotbe Ravandi Boulevard
    Street address - Persian: بلوار قطب راوندي، معاونت پ‍ژوهشي
    City - English: Kashan
    City - Persian: كاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5554 0021
    Fax:
    Email: hamidi_g@kaums.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: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Beheshti Hospital
    Street address - Persian: بيمارستان شهيد بهشتي
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: samimi_m@kaums.ac.ir; dr_samimi.2007@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 پزشكي كاشان
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree: specialist
    Area of specialty/work: 49
    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: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: dr_samimi.2007@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: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Beheshti Hospital
    Street address - Persian: بيمارستان شهيد بهشتي
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: samimi_m@kaums.ac.ir; dr_samimi.2007@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: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree: specialist
    Area of specialty/work: 49
    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: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: dr_samimi.2007@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 پزشكي كاشان
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Beheshti Hospital
    Street address - Persian: بيمارستان شهيد بهشتي
    City - English: Kashan
    City - Persian: كاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: samimi_m@kaums.ac.ir; dr_samimi.2007@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 پزشكي كاشان
    Full name of responsible person - English: Dr Mansooreh Samimi
    Full name of responsible person - Persian: دكتر منصوره صميمي
    Position - English: Obstetricians
    Position - Persian: متخصص زنان و زايمان
    Latest degree: specialist
    Area of specialty/work: 49
    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: كاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5544 7619
    Mobile: +98 913 361 4710
    Fax:
    Email: dr_samimi.2007@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
This study is to determine the effects of vitamin D on metabolic profiles, hs-CRP and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Sixty pregnant women of eligible and referred to Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primigravida pregnant women; aged 18–40 years old; at risk for pre-eclampsia; lived approximately 20 km or less from the clinic and hospital. Exclusion criteria: Hypertension; renal diseases; gestational diabetes mellitus (GDM); abnormal foetal anomaly scan
Intervention groups
Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks and 1000 mg calcium daily (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Pre-eclampsia rate, low birth weight (LBW) (<2500 g), newborn's birth size and preterm delivery (<37 weeks) (primary outcomes) and other metabolic profiles (secondary outcome).

General information

Reason for update
Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were 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: IRCT201102135444N3
Registration date: 2015-01-31, 1393/11/11
Registration timing: retrospective

Last update: 2021-05-27, 1400/03/06
Update count: 1
Registration date
2015-01-31, 1393/11/11
Registrant information
Name
Mansoore Samimi
Name of organization / entity
Kashan
Country
Iran (Islamic Republic of)
Phone
+98 36 1446 0180
Email address
samimi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2014-10-06, 1393/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia
Public title
Effect of supplementation in treatment of pregnancy complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravida pregnant women Aged 18–40 years old At risk for pre-eclampsia Lived approximately 20 km or less from the clinic and hospital
Exclusion criteria:
Hypertension Renal diseases Gestational diabetes mellitus (GDM) Abnormal foetal anomaly scan
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization 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 be allocated 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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2014-03-31, 1393/01/11
Ethics committee reference number
196/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Pre-eclampsia
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Pre-eclampsia rate
Timepoint
After delivery
Method of measurement
Medical record

2

Description
Low birth weight (LBW) (<2500 g)
Timepoint
After delivery
Method of measurement
Scale

3

Description
Newborn's birth size
Timepoint
After delivery
Method of measurement
Scale and tape

4

Description
Preterm delivery (<37 weeks)
Timepoint
After delivery
Method of measurement
Medical record

Secondary outcomes

1

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Eliza

2

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

3

Description
High-sensitivity C-reactive protein
Timepoint
Baseline and End-of-trial
Method of measurement
Eliza

4

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

5

Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

6

Description
Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

7

Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

8

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

9

Description
Blood pressures
Timepoint
Baseline and End-of-trial
Method of measurement
Manometer

Intervention groups

1

Description
Intervention group: 50000 IU vitamin D pearl, each two weeks for 12 weeks + 1000 mg calcium tablet, daily for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Vitamin D Placebo pearl, each two weeks for 12 weeks + Calcium Placebo tablet, daily for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gynecology Clinic
Full name of responsible person
Dr Mansooreh Samimi
Street address
Shahid Rajaee Street, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
dr_samimi.2007@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Vice chancellor for research, Ghotbe Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
hamidi_g@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mansooreh Samimi
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5544 7619
Fax
Email
dr_samimi.2007@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mansooreh Samimi
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5544 7619
Fax
Email
dr_samimi.2007@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
Dr Mansooreh Samimi
Position
Obstetricians
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5544 7619
Fax
Email
dr_samimi.2007@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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