Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Objective: The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Pregnant women at risk for intrauterine growth restriction and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either selenium supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 14-wk intervention. Start and end date of intervention: 14 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
empty
Objective: The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Pregnant women at risk for intrauterine growth restriction and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either selenium supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 14-wk intervention. Start and end date of intervention: 14 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سلنیوم بر پروفایل های متابولیک در زنان باردار در معرض خطر کاهش رشد داخل رحمی است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: زنان باردار در معرض خطر کاهش رشد داخل رحمی در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار در معرض خطر کاهش رشد داخل رحمی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: شرکت کنندگان برای دریافت مکمل سلنیوم (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 14 هفته بعد از مداخله از شرکت کنندگان گرفته خواهد شد. زمان مداخله: 14 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری سلنیوم بر پروفایل های متابولیک در زنان باردار در معرض خطر کاهش رشد داخل رحمی است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: زنان باردار در معرض خطر کاهش رشد داخل رحمی در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 زن باردار در معرض خطر کاهش رشد داخل رحمی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: شرکت کنندگان برای دریافت مکمل سلنیوم (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 14 هفته بعد از مداخله از شرکت کنندگان گرفته خواهد شد. زمان مداخله: 14 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
empty
The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction.
The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction.
empty
هدف این مطالعه تعیین اثرات مکمل یاری سلنیوم بر پروفایل های متابولیک در زنان باردار در معرض خطر کاهش رشد داخل رحمی است.
هدف این مطالعه تعیین اثرات مکمل یاری سلنیوم بر پروفایل های متابولیک در زنان باردار در معرض خطر کاهش رشد داخل رحمی است.
empty
Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial.
Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial.
empty
طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی.
طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم شرکت کنندگان و هم محققان) موازی.
empty
Sixty pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Fasting blood samples will be taken at baseline and after 10-wk intervention.
Sixty pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Fasting blood samples will be taken at baseline and after 10-wk intervention.
empty
60 زن باردار در معرض خطر کاهش رشد داخل رحمی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران انتخاب خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 10 هفته بعد از مداخله از شرکت کنندگان گرفته خواهد شد.
60 زن باردار در معرض خطر کاهش رشد داخل رحمی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران انتخاب خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 10 هفته بعد از مداخله از شرکت کنندگان گرفته خواهد شد.
empty
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking selenium supplements during past 3 months, Hypo- and hyperthyroidism, Urinary tract infection, Pre-eclampsia, Hypertension, Diseases related to increased inflammation, Smokers and Kidney or liver diseases.
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking selenium supplements during past 3 months, Hypo- and hyperthyroidism, Urinary tract infection, Pre-eclampsia, Hypertension, Diseases related to increased inflammation, Smokers and Kidney or liver diseases.
empty
معیار ورود به مطالعه: زنان باردار در معرض خطر کاهش رشد داخل رحمی و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: مصرف مکمل های سلنیوم در 3 ماه گذشته، کم کاری و پرکاری تیروئید، عفونت مجاری ادراری، پره اکلامپسی، فشارخون بالا، بیماری های مرتبط با افزایش التهاب، افراد سیگاری و بیماری های کلیوی و کبدی.
معیار ورود به مطالعه: زنان باردار در معرض خطر کاهش رشد داخل رحمی و در محدوده سنی 18 تا 40 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: مصرف مکمل های سلنیوم در 3 ماه گذشته، کم کاری و پرکاری تیروئید، عفونت مجاری ادراری، پره اکلامپسی، فشارخون بالا، بیماری های مرتبط با افزایش التهاب، افراد سیگاری و بیماری های کلیوی و کبدی.
empty
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally.
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally.
empty
گروه مداخله: مکمل سلنیوم (نیچر مد، کالیفرنیا، آمریکا)، 100 میکروگرم، روزانه، به صورت خوراکی برای 10 هفته.
گروه کنترل: پلاسبو (شرکت باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 10 هفته.
گروه مداخله: مکمل سلنیوم (نیچر مد، کالیفرنیا، آمریکا)، 100 میکروگرم، روزانه، به صورت خوراکی برای 10 هفته. گروه کنترل: پلاسبو (شرکت باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 10 هفته.
empty
Biomarkers of oxidative stress and Pulsatility Index (primary outcomes) and lipid profiles, markers of insulin metabolism and inflammatory factors (secondary outcomes)
Biomarkers of oxidative stress and Pulsatility Index (primary outcomes) and lipid profiles, markers of insulin metabolism and inflammatory factors (secondary outcomes)
empty
بیومارکرهای استرس اکسیداتیو و شاخص ضربانی (پیامدهای اولیه) و پروفایل های لیپیدی و مارکرهای متابولیسم انسولین، فاکتورهای التهابی (پیامدهای ثانویه)
بیومارکرهای استرس اکسیداتیو و شاخص ضربانی (پیامدهای اولیه) و پروفایل های لیپیدی و مارکرهای متابولیسم انسولین، فاکتورهای التهابی (پیامدهای ثانویه)
General information
1
1
1
1
2
3
23
2015-12-22, 1394/10/01
2015-12-23, 1394/10/02
2015-12-2223 00:00:00
2016-02-20, 1394/12/01
2016-01-23, 1394/11/03
2016-0201-2023 00:00:00
Pregnant women at risk for intrauterine growth restriction
Aged 18 to 40 years
Pregnant women at risk for intrauterine growth restriction Aged 18 to 40 years
زنان باردار در معرض خطر کاهش رشد داخل رحمی
در محدوده سنی 18 تا 40 سال
زنان باردار در معرض خطر کاهش رشد داخل رحمی در محدوده سنی 18 تا 40 سال
Taking selenium supplements during past 3 months
Hypo- and hyperthyroidism
Urinary tract infection
Pre-eclampsia
Hypertension
Diseases related to increased inflammation
Smokers
Kidney or liver diseases
Taking selenium supplements during past 3 months Hypo- and hyperthyroidism Urinary tract infection Pre-eclampsia Hypertension Diseases related to increased inflammation Smokers Kidney or liver diseases
مصرف مکمل های سلنیوم در 3 ماه گذشته
کم کاری و پرکاری تیروئید
عفونت مجاری ادراری
پره اکلامپسی
فشارخون بالا
بیماری های مرتبط با افزایش التهاب
افراد سیگاری
بیماری های کلیوی و کبدی
مصرف مکمل های سلنیوم در 3 ماه گذشته کم کاری و پرکاری تیروئید عفونت مجاری ادراری پره اکلامپسی فشارخون بالا بیماری های مرتبط با افزایش التهاب افراد سیگاری بیماری های کلیوی و کبدی
empty
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. 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
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. 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
empty
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی و سن تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو 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
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی و سن تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو 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
empty
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 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.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 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.
empty
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک نقوی 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. 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.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک نقوی 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. 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.
empty
empty
Health conditions studied
#1
094
O94
094O94
Primary outcomes
#1
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10 هفته بعد از مداخله
در ابتدای مطالعه و 1410 هفته بعد از مداخله
#2
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#3
empty
Pulsatility index
Pulsatility index
empty
شاخص ضربانی
شاخص ضربانی
empty
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
empty
در ابتدای مطالعه و 10 هفته بعد از مداخله
در ابتدای مطالعه و 10 هفته بعد از مداخله
empty
Sonography
Sonography
empty
سونوگرافی
سونوگرافی
Secondary outcomes
#1
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#2
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#3
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#4
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#5
At the beginning of the study and after 14 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 1410 weeks of intervention
در ابتدای مطالعه و 14 هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 14 هفته10هفته بعد از مداخله
#6
empty
Malondialdehyde
Malondialdehyde
empty
ماون دی آلدئید
ماون دی آلدئید
empty
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
empty
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
#7
empty
HDL
HDL
empty
HDL
HDL
empty
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
empty
در ابتدای مطالعه و 10هفته بعد از مداخله
در ابتدای مطالعه و 10هفته بعد از مداخله
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#8
empty
Fasting plasma glucose
Fasting plasma glucose
empty
قند خون ناشتا
قند خون ناشتا
empty
At the beginning of the study and after 10 weeks of intervention
At the beginning of the study and after 10 weeks of intervention
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally.
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 1410 weeks orally.
گروه مداخله: مکمل سلیوم، 100 میکروگرم، روزانه، به صورت خوراکی برای 14 هفته.
گروه مداخله: مکمل سلنیوم (نیچر مد، کالیفرنیا، آمریکا)، 100 میکروگرم، روزانه، به صورت خوراکی برای 10 هفته.
گروه مداخله: مکمل سلیومسلنیوم (نیچر مد، کالیفرنیا، آمریکا)، 100 میکروگرم، روزانه، به صورت خوراکی برای 1410 هفته.
#2
Control group: Placebo, daily, for 14 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 1410 weeks orally.
گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 14 هفته.
گروه کنترل: پلاسبو (شرکت باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 10 هفته.
گروه کنترل: پلاسبو (شرکت باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 1410 هفته.
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, 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:
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, 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 5554 0026
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi Clinic Name of recruitment center - Persian: کلینیک نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Ghotbe Ravandi Boulevard, 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 5554 0026 Fax: Email: asemi_z@kaums.ac.ir 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: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, 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: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5557 8010
Fax:
Email: research@kaums.ac.ir
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: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5557 8010 Fax: Email: research@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
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: متخصص تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5562 0608
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: 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: متخصص تغذیه Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5562 0608 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; 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: PhD of Nutrition
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: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
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
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of selenium supplementation on metabolic profiles in pregnant women at risk for intrauterine growth restriction.
Design
Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial.
Settings and conduct
Sixty pregnant women at risk for intrauterine growth restriction of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Fasting blood samples will be taken at baseline and after 10-wk intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women at risk for intrauterine growth restriction and aged 18 to 40 years will be included in this study. Exclusion criteria: Taking selenium supplements during past 3 months, Hypo- and hyperthyroidism, Urinary tract infection, Pre-eclampsia, Hypertension, Diseases related to increased inflammation, Smokers and Kidney or liver diseases.
Intervention groups
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally.
Main outcome variables
Biomarkers of oxidative stress and Pulsatility Index (primary outcomes) and lipid profiles, markers of insulin metabolism and inflammatory factors (secondary outcomes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201601045623N64
Registration date:2016-01-31, 1394/11/11
Registration timing:retrospective
Last update:2019-09-25, 1398/07/03
Update count:1
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-12-23, 1394/10/02
Expected recruitment end date
2016-01-23, 1394/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction
Public title
Effect of supplementation in treatment of pregnant women at risk for intrauterine growth restriction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women at risk for intrauterine growth restriction
Aged 18 to 40 years
Exclusion criteria:
Taking selenium supplements during past 3 months
Hypo- and hyperthyroidism
Urinary tract infection
Pre-eclampsia
Hypertension
Diseases related to increased inflammation
Smokers
Kidney or liver diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. 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 Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 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
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.Kaums.REC.1394.131
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
Total antioxidant
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Pulsatility index
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
hs-CRP
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Elisa kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Cholesterol
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
HDL
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 10 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 10 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
asemi_z@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
research@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
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_z@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available