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Effects of vitamin D supplementation on metabolic profiles in pregnant women who are at risk of pre-eclampsia

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History
# Registration date Revision Id
2 2019-09-15, 1398/06/24 103852
1 2014-10-04, 1393/07/12 6057
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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 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 50000 IU vitamin D/each 2 weeks (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 (July 23, 2014- October 23, 2014). Outcomes: Baseline and End-of-trial serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides levels, fasting plasma glucose (FPG), plasma total antioxidant capacity (TAC) and total glutathione (GSH).
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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 کوثر اراک وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت 50000 واحد ویتامین D هر دو هفته یک بار (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: 12 هفته (از 1 مرداد 1393 تا 1 آبان 1393). پيامدهای اوليه مورد مطالعه: سطوح سرمی کلسترول توتال،کلسترولLDL ، کلسترولHDL و تری گلیسرید، گلوکز پلاسمایی ناشتا، توتال آنتی اکسیدان پلاسما و گلوتاتیون توتال.
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    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.
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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.
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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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    Population and sample size: 60 pregnant women of eligible and referred to Taleghani and Emam Reza Clinics 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: 60 زن باردار واجد شرایط و ارجاع شده به کلینیک طالقانی و امام رضا اراک وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Pregnant women primigravida and aged 18 to 40 years and at risk for pre-eclampsia will be included in this study. Exclusion criteria: Unable or unwilling to give written informed consent, Abnormal fetal anomaly scan and treated with warfarin
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    معیار ورود به مطالعه: زنان باردار پرایمی گراویدیا در محدوده سنی 18 تا 40 سال و در معرض خطر پری اکلامپسی وارد مطالعه خواهند شد. معیار خروج از مطالعه: قادر نبودن یا عدم تمایل به دادن رضایت آگاهانه، اسکن ناهنجاری غیرطبیعی جنین و تحت درمان با وارفارین.
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    Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks (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 (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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    پری 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

    1
    1
    1
    N/A
    3
    Pregnant women primigravida
    Aged 18-40 years old
    At risk for pre-eclampsia
    زنان باردار پرایمی گراویدیا
    سن 18 تا 40 سال
    در معرض خطر پری اکلامپسی
    Unable or unwilling to give written informed consent
    Abnormal fetal anomaly scan
    Treated with warfarin
    قادر نبودن یا عدم تمایل به دادن رضایت آگاهانه
    اسکن ناهنجاری غیرطبیعی جنین
    تحت درمان با وارفارین
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    At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین دی (n=30) و پلاسبو (n=30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at gynecology clinic affiliated to Arak University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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 زنان وابسته به دانشگاه علوم پزشکی اراک که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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  • Primary outcomes

    #1
    Insulin
    Pre-eclampsia rate
    انسولین
    میزان پری اکلامپسی
    Baseline and End-of-trial
    After delivery
    ابتدا و انتهای مطالعه
    بعد زایمان
    Eliza
    Medical record
    الایزا
    پرونده پزشکی
    #2
    Nitric oxide
    Low birth weight (LBW) (<2500 g)
    نیتریک اکساید
    کاهش وزن تولد
    Baseline and End-of-trial
    After delivery
    ابتدا و انتهای مطالعه
    بعد زایمان
    Spectrophotometry
    Scale
    اسپکتروفتومتری
    ترازو
    #3
    hs-CRP
    Newborn's birth size
    پروتئین واکنشگر C با حساسیت بالا
    سایز تولد نوزادان تازه متولد شده
    Baseline and End-of-trial
    After delivery
    ابتدا و انتهای مطالعه
    بعد زایمان
    Eliza
    Scale and tape
    الایزا
    ترازو و متر
    #4
    Total antioxidant capacity
    Preterm delivery (<37 weeks)
    ظرفیت آنتی اکسیدانی توتال
    زایمان زودرس
    Baseline and End-of-trial
    After delivery
    ابتدا و انتهای مطالعه
    بعد زایمان
    Spectrophotometry
    Medical record
    اسپکتروفتومتری
    پرونده پزشکی
    #5
    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
    empty
    #6
    Triglyceride
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    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #7
    Cholesterol
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    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #8
    HDL-cholesterol
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    کلسترول HDL
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    Baseline and End-of-trial
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    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty

  • Secondary outcomes

    #1
    empty
    Insulin
    empty
    انسولین
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Eliza
    empty
    الایزا
    #2
    empty
    Nitric oxide
    empty
    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #3
    empty
    hs-CRP
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    پروتئین واکنشگر C با حساسیت بالا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Eliza
    empty
    الایزا
    #4
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
    empty
    Fasting plasma glucose
    empty
    قند خون ناشتا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #6
    empty
    Triglyceride
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #7
    empty
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    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
    empty
    Manometer
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    مانومتر

  • 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: Taleghani and Emam Reza Clinics
    Name of recruitment center - Persian: کلینیک طالقانی و امام رضا
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    Street address - English: Arak, Emam Khomaini Street, Taleghani Hospital
    Street address - Persian: اراک، خیابان امام خمینی، بیمارستان طالقانی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 9819693345
    Phone: +98 86 1278 0660
    Fax:
    Email: dr.karamali@arakmu.ac.ir
    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: 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: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3819693345
    Phone: +98 86 1278 0660
    Fax:
    Email: dr.karamali@arakmu.ac.ir
    Web page address:
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    Public
    empty
    Domestic
    empty
    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: 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: 8115187159
    Phone: +98 985 546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical 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: 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: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac
    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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac
    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: 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
Population and sample size: 60 pregnant women of eligible and referred to Taleghani and Emam Reza Clinics affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women primigravida and aged 18 to 40 years and at risk for pre-eclampsia will be included in this study. Exclusion criteria: Unable or unwilling to give written informed consent, Abnormal fetal anomaly scan and treated with warfarin
Intervention groups
Patients will be assigned to receive either 50000 IU vitamin D/each 2 weeks (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
Acronym
IRCT registration information
IRCT registration number: IRCT201410035623N27
Registration date: 2014-10-04, 1393/07/12
Registration timing: retrospective

Last update: 2019-09-16, 1398/06/25
Update count: 1
Registration date
2014-10-04, 1393/07/12
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
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on metabolic profiles in pregnant women who are at risk of pre-eclampsia
Public title
Effect of supplementation in treatment of pregnancy complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women primigravida Aged 18-40 years old At risk for pre-eclampsia
Exclusion criteria:
Unable or unwilling to give written informed consent Abnormal fetal anomaly scan Treated with warfarin
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at gynecology clinic affiliated to Arak University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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
3819693345
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
92/151/2

Health conditions studied

1

Description of health condition studied
Pregnancy
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
hs-CRP
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: Vitamin D pearl, 50000 IU, each two weeks for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo pearl, each two weeks for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani and Emam Reza Clinics
Full name of responsible person
Maryam Karamali
Street address
Arak, Emam Khomaini Street, Taleghani Hospital
City
Arak
Province
Markazi
Postal code
9819693345
Phone
+98 86 1278 0660
Email
dr.karamali@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Karamali
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 1278 0660
Email
dr.karamali@arakmu.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
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
8115187159
Phone
+98 985 546 3378
Email
asemi_z@kaums.ac.ir

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
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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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