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Protocol summary
Objective: The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and 6 weeks after intervention to measure biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and end date of intervention: 6 weeks (July 27, 2015-September 11, 2015). Outcomes: Biomarkers of oxidative stress will be measured at study baseline and end-of-trial.
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Objective: The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion and exclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and 6 weeks after intervention to measure biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and end date of intervention: 6 weeks (July 27, 2015-September 11, 2015). Outcomes: Biomarkers of oxidative stress will be measured at study baseline and end-of-trial.
هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب امگا-3 و ویتامین E بر پیامدهای بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آن هایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 6 هفته بعد از مداخله برای تعیین بیومارکرهای استرس اکسیداتیو گرفته خواهد شد. اگرچه طول مدت مداخله 6 هفته خواهد بود، ولی همه شرکت کنندگان تا زمان زایمان پیگیری خواهند شد. زمان شروع و اتمام مداخله: 6 هفته (از 5 مرداد 1394 تا 20 شهریور 1394). پيامدها: بیومارکرهای استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب امگا-3 و ویتامین E بر پیامدهای بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. معیار ورود و خروج مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری وارد خواهند شد. استفاده از درمان های جایگزین از قبیل هورمون یا مکمل ویتامینی و همچنین آن هایی که مبتلا به پری اکلامسی، استراحت مطلق، مرگ جنینی داخل رحمی، جدا شدن جفت و زایمان زودرس می شوند از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدا و 6 هفته بعد از مداخله برای تعیین بیومارکرهای استرس اکسیداتیو گرفته خواهد شد. اگرچه طول مدت مداخله 6 هفته خواهد بود، ولی همه شرکت کنندگان تا زمان زایمان پیگیری خواهند شد. زمان شروع و اتمام مداخله: 6 هفته (از 5 مرداد 1394 تا 20 شهریور 1394). پيامدها: بیومارکرهای استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes.
The aim of the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes.
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هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب امگا-3 و ویتامین E بر پیامدهای بارداری در دیابت بارداری است.
هدف مطالعه حاضر ارزیابی اثرات مکمل یاری ترکیب امگا-3 و ویتامین E بر پیامدهای بارداری در دیابت بارداری است.
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به دیابت بارداری در میان زنان باردار واجد شرایط و ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. Exclusion criteria: Placenta abruption, preeclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases.
Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. Exclusion criteria: Placenta abruption, preeclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases.
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معیار ورود مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری وارد خواهند شد. معیار خروج از مطالعه: جدا شدن زودرس جفت، پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری های کلیوی و کبدی.
معیار ورود مطالعه: در مطالعه حاضر، زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری وارد خواهند شد. معیار خروج از مطالعه: جدا شدن زودرس جفت، پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت ادراری، افراد سیگاری، بیماری های کلیوی و کبدی.
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Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30).
Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30).
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مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد.
مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله: 30n=) یا پلاسبو (گروه کنترل30n=) تقسیم خواهند شد.
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Outcomes: Biomarkers of oxidative stress and inflammation (primary outcomes) and pregnancy outcomes (secondary outcome).
Outcomes: Biomarkers of oxidative stress and inflammation (primary outcomes) and pregnancy outcomes (secondary outcome).
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پيامدها: بیومارکرهای استرس اکسیداتیو و التهابی (پیامدهای اولیه) و و پیامد بارداری (پیامدهای ثانویه).
پيامدها: بیومارکرهای استرس اکسیداتیو و التهابی (پیامدهای اولیه) و و پیامد بارداری (پیامدهای ثانویه).
General information
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2015-07-13, 1394/04/22
2015-06-09, 1394/03/19
2015-0706-1309 00:00:00
2015-07-27, 1394/05/05
2015-07-19, 1394/04/28
2015-07-2719 00:00:00
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Due to an error, the request for an update in our website was 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.
Due to an error, the request for an update in our website was 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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بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 week gestation
Pregnant women aged 18-40 years Diagnosed with GDM at 24-28 week gestation
زنان باردار 40-18 ساله؛
مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
زنان باردار 40-18 ساله؛ مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
Placenta abruption
Preeclampsia
Eclampsia
Hypo- and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Placenta abruption Preeclampsia Eclampsia Hypo- and hyperthyroidism Urinary tract infection Smokers Kidney or liver diseases
جدا شدن زودرس جفت
پره اکلامپسی
اکلامپسی
کم کاری و پرکاری تیروئید
عفونت ادراری
افراد سیگاری
بیماری های کلیوی و کبدی
جدا شدن زودرس جفت پره اکلامپسی اکلامپسی کم کاری و پرکاری تیروئید عفونت ادراری افراد سیگاری بیماری های کلیوی و کبدی
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At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take combined omega-3 and vitamin E supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and weeks of gestation, subjects will be randomly divided into two groups to take combined omega-3 and vitamin E supplementation (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 ترکیب مکمل امگا-3 و ویتامین E (n = 30) و پلاسبو (n =30) تخصیص داده می شوند. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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 ترکیب مکمل امگا-3 و ویتامین E (n = 30) و پلاسبو (n =30) تخصیص داده می شوند. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Participants, investigators or the assessors of the outcomes are unaware of the study groups. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology 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 placebos capsules are similar in shape and size.
Participants, investigators or the assessors of the outcomes are unaware of the study groups. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology 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 placebos capsules are similar in shape and size.
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شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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 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 از نظر شکل و اندازه مشابه هستند.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. 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 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 از نظر شکل و اندازه مشابه هستند.
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Primary outcomes
#1
Newborns' weight
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Newborns' weight
وزن نوزادان تازه متولد شده
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وزن نوزادان تازه متولد شده
The first 24 h after birth
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The first 24 h after birth
24 ساعت اول بعد از تولد
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24 ساعت اول بعد از تولد
Scale
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Scale
ترازو
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ترازو
#2
Newborn length
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Newborn length
قد نوزادان تازه متولد شده
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قد نوزادان تازه متولد شده
The first 24 h after birth
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The first 24 h after birth
24 ساعت اول بعد از تولد
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24 ساعت اول بعد از تولد
Girth measuring tape
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Girth measuring tape
متر نواری
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متر نواری
#3
Newborn head circumference
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Newborn head circumference
محیط دور سر نوزادان تازه متولد شده
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محیط دور سر نوزادان تازه متولد شده
The first 24 h after birth
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The first 24 h after birth
24 ساعت اول بعد از تولد
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24 ساعت اول بعد از تولد
Girth measuring tape
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Girth measuring tape
متر نواری
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متر نواری
#4
Polyhydramnios
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Polyhydramnios
پلی هیدروآمونیوس
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پلی هیدروآمونیوس
Post-intervention
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Post-intervention
بعد از مداخله
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بعد از مداخله
Sonography
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Sonography
سونوگرافی
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سونوگرافی
Secondary outcomes
#1
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Newborn length
Newborn length
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قد نوزادان تازه متولد شده
قد نوزادان تازه متولد شده
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The first 24 h after birth
The first 24 h after birth
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24 ساعت اول بعد از تولد
24 ساعت اول بعد از تولد
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Scale
Scale
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متر نواری
متر نواری
#2
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Newborns' weight
Newborns' weight
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وزن نوزادان تازه متولد شده
وزن نوزادان تازه متولد شده
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The first 24 h after birth
The first 24 h after birth
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24 ساعت اول بعد از تولد
24 ساعت اول بعد از تولد
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Scale
Scale
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ترازو
ترازو
#3
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Polyhydramnios
Polyhydramnios
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پلی هیدروآمونیوس
پلی هیدروآمونیوس
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After the intervention
After the intervention
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بعد از مداخله
بعد از مداخله
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Sonography
Sonography
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سونوگرافی
سونوگرافی
#4
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Newborn's head circumference
Newborn's head circumference
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دور سر نوزادان
دور سر نوزادان
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Delivery time
Delivery time
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زمان زایمان
زمان زایمان
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Tape
Tape
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متر نواری
متر نواری
#5
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Newborn's bilirubin
Newborn's bilirubin
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بیلی روبین نوزادان تازه متولد شده
بیلی روبین نوزادان تازه متولد شده
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Delivery time
Delivery time
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زمان زایمان
زمان زایمان
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#6
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Apgar score
Apgar score
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عدد آپگار
عدد آپگار
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Delivery time
Delivery time
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زمان زایمان
زمان زایمان
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Clinical observation
Clinical observation
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مشاهده بالینی
مشاهده بالینی
#7
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Preterm delivery
Preterm delivery
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زایمان زودرس
زایمان زودرس
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After delivery
After delivery
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بعد زایمان
بعد زایمان
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Medical record
Medical record
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پرونده پزشکی
پرونده پزشکی
#8
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Maternal pre-eclampsia
Maternal pre-eclampsia
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پری اکلامپسی مادران باردار
پری اکلامپسی مادران باردار
empty
After delivery
After delivery
empty
بعد زایمان
بعد زایمان
empty
Medical record
Medical record
empty
پرونده پزشکی
پرونده پزشکی
#9
empty
Maternal hospitalization
Maternal hospitalization
empty
بستری شدن مادران
بستری شدن مادران
empty
After delivery
After delivery
empty
بعد زایمان
بعد زایمان
empty
Medical record
Medical record
empty
پرونده پزشکی
پرونده پزشکی
#10
empty
Newborns' hospitalization
Newborns' hospitalization
empty
بستری شدن نوزادان تازه متولد شده
بستری شدن نوزادان تازه متولد شده
empty
After delivery
After delivery
empty
بعد زایمان
بعد زایمان
empty
Medical record
Medical record
empty
پرونده پزشکی
پرونده پزشکی
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English:
Street address - Persian:
City - English: Arak
City - Persian: اراک
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3848176941
Phone: +98 84 3223 3823
Fax:
Email: research@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Kosar Clinic Name of recruitment center - Persian: کلینیک کوثر Full name of responsible person - English: Mehri Jamilian Full name of responsible person - Persian: مهری جمیلیان Street address - English: Emam Khomeyni Avenue, Arak Street address - Persian: اراک، خیابان امام خمینی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3848176941 Phone: +98 84 3223 3823 Fax: Email: research@arakmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاون ت حقیقات و فناوری دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک
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: Vice chancellor for research, Arak University of Medical Sciences
Name of organization / entity - Persian: معاونت حقیقات و فناوری دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Mohammad Rafiee
Full name of responsible person - Persian: محمد رفیعی
Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
Street address - Persian: اراك، خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3848176941
Phone: +98 86 3417 3639
Fax:
Email: research@arakmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Arak University of Medical Sciences Name of organization / entity - Persian: معاون تمعاونت حقیقات و فناوری دانشگاه علوم پزشکی اراک Full name of responsible person - English: Mohammad Rafiee Full name of responsible person - Persian: محمد رفیعی Street address - English: Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak Street address - Persian: اراك، خیابان سردشت، معاونت پژوهشی دانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3848176941 Phone: +98 86 3417 3639 Fax: Email: research@arakmu.ac.ir Web page address:
Yes
empty
1
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
معاون ت حقیقات و فناوری دانشگاه علوم پزشکی اراک
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی اراک
معاون ت حقیقاتمعاونت تحقیقات و فناوری دانشگاه علوم پزشکی اراک
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: دکترای 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: 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: دکترای 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:
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: دکترای 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: دکترای 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
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: دکترای 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.comkaums.ac 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
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.comkaums.ac 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 the current study is to evaluate the effects of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Kosar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In the current study, pregnant women aged 18-40 years with gestational diabetes (GDM) at 24-28 week gestation will be included. Exclusion criteria: Placenta abruption, preeclampsia, eclampsia, hypo- and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases.
Intervention groups
Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Outcomes: Biomarkers of oxidative stress and inflammation (primary outcomes) and pregnancy outcomes (secondary outcome).
General information
Reason for update
Due to an error, the request for an update in our website was 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:IRCT201507035623N47
Registration date:2015-07-19, 1394/04/28
Registration timing:retrospective
Last update:2019-11-10, 1398/08/19
Update count:1
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-06-09, 1394/03/19
Expected recruitment end date
2015-07-19, 1394/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined omega-3 and vitamin E supplementation on pregnancy outcomes in gestational diabetes
Public title
Effect of supplementation in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-40 years
Diagnosed with GDM at 24-28 week gestation
Exclusion criteria:
Placenta abruption
Preeclampsia
Eclampsia
Hypo- and hyperthyroidism
Urinary tract infection
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
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 weeks of gestation, subjects will be randomly divided into two groups to take combined omega-3 and vitamin E supplementation (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
Participants, investigators or the assessors of the outcomes are unaware of the study groups. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology 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 placebos capsules are similar in shape and size.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethicc's committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.ARAKMU.REC.1394.37
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
4
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
5
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Scale
2
Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale
3
Description
Polyhydramnios
Timepoint
After the intervention
Method of measurement
Sonography
4
Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape
5
Description
Newborn's bilirubin
Timepoint
Delivery time
Method of measurement
Enzymatic kit
6
Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation
7
Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record
8
Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record
9
Description
Maternal hospitalization
Timepoint
After delivery
Method of measurement
Medical record
10
Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record
Intervention groups
1
Description
Intervention group: Combined omega-3 and vitamin E pearl, 1000 mg omega-3 and 400 IU vitamin E, daily, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, daily, for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 84 3223 3823
Email
research@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Vice chancellor for research, Arak University of Medical Sciences, Sardasht Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, 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
81151-87159
Phone
+98 31 5546 3378
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
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
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