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Protocol summary
Objective: The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. 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: 50 patients with GDM among 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 vitamin D plus calcium supplements (intervention group: n=25) or placebo (control group: n=25). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (March 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
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Objective: The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. 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: 50 patients with GDM among 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 vitamin D plus calcium supplements (intervention group: n=25) or placebo (control group: n=25). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (March 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب ویتامین D و کلسیم بر پیامدهای بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه 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: 50 زن باردار مبتلا به دیابت بارداری 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 ترکیب ویتامین D و کلسیم (گروه مداخله: 25n=) یا پلاسبو (گروه کنترل25n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین سطوح سرمی ویتامین D و کلسیم از بیماران گرفته خواهد شد. اگرچه مدت مداخله 6 هفته خواهد بود، ولی بیماران تا زمان زایمان پیگیری خواهند شد. زمان مداخله: 5 ماه (از 19 اسفند 1392 تا 19 مرداد 1393). پيامدها: پلی هیدروآمونیوس با روش سونوگرافی در انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب ویتامین D و کلسیم بر پیامدهای بارداری در دیابت بارداری است. طراحی مطالعه: تصادفي کارآزمایی بالینی دو سوکور موازی. معیار ورود و خروج مطالعه: زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه 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: 50 زن باردار مبتلا به دیابت بارداری 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 ترکیب ویتامین D و کلسیم (گروه مداخله: 25n=) یا پلاسبو (گروه کنترل25n=) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین سطوح سرمی ویتامین D و کلسیم از بیماران گرفته خواهد شد. اگرچه مدت مداخله 6 هفته خواهد بود، ولی بیماران تا زمان زایمان پیگیری خواهند شد. زمان مداخله: 5 ماه (از 19 اسفند 1392 تا 19 مرداد 1393). پيامدها: پلی هیدروآمونیوس با روش سونوگرافی در انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes.
The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes.
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هدف این مطالعه تعیین اثرات مکمل یاری ترکیب ویتامین D و کلسیم بر پیامدهای بارداری در دیابت بارداری است.
هدف این مطالعه تعیین اثرات مکمل یاری ترکیب ویتامین D و کلسیم بر پیامدهای بارداری در دیابت بارداری است.
60 patients with GDM among pregnant women of eligible and referred to maternity Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
60 patients with GDM among pregnant women of eligible and referred to maternity Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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60 زن باردار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک های زایمان وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
60 زن باردار مبتلا به دیابت بارداری واجد شرایط و ارجاع شده به کلینیک های زایمان وابسته به دانشگاه علوم پزشکی اراک، اراک، ایران در مطالعه انتخاب خواهند شد.
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Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria will be multiple gestation, major fetal anomalies, current illicit drug use, continuous daily Ca and/or vitamin D intake since last menstrual period, insulin-dependent diabetes, smoking and history of kidney stones.
Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria will be multiple gestation, major fetal anomalies, current illicit drug use, continuous daily Ca and/or vitamin D intake since last menstrual period, insulin-dependent diabetes, smoking and history of kidney stones.
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زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. معیارهای خروج از مطالعه شامل حاملگی های متعدد ، ناهنجاریهای عمده جنینی ، استفاده از داروهای مخدر فعلی ، مصرف روزانه مداوم کلسیم و یا ویتامین D از زمان آخرین قاعدگی ، دیابت وابسته به انسولین ، سیگار کشیدن و سابقه سنگ کلیه خواهد بود.
زنان باردار 40-18 ساله مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری، در این مطالعه وارد خواهند شد. معیارهای خروج از مطالعه شامل حاملگی های متعدد ، ناهنجاریهای عمده جنینی ، استفاده از داروهای مخدر فعلی ، مصرف روزانه مداوم کلسیم و یا ویتامین D از زمان آخرین قاعدگی ، دیابت وابسته به انسولین ، سیگار کشیدن و سابقه سنگ کلیه خواهد بود.
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Patients will be assigned to receive either vitamin D plus calcium supplements (intervention group: n=30) or placebo (control group: n=30).
Patients will be assigned to receive either vitamin D plus calcium supplements (intervention group: n=30) or placebo (control group: n=30).
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بیماران برای دریافت ترکیب ویتامین D و کلسیم (گروه مداخله: n=30) یا پلاسبو (گروه کنترل n=30) تقسیم خواهند شد.
بیماران برای دریافت ترکیب ویتامین D و کلسیم (گروه مداخله: n=30) یا پلاسبو (گروه کنترل n=30) تقسیم خواهند شد.
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Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
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نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین سطوح سرمی ویتامین D و کلسیم از بیماران گرفته خواهد شد. پلی هیدروآمونیوس با روش سونوگرافی در انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله برای تعیین سطوح سرمی ویتامین D و کلسیم از بیماران گرفته خواهد شد. پلی هیدروآمونیوس با روش سونوگرافی در انتهای مداخله اندازه گیری خواهد شد. وزن، قد، دور سر، عدد آپگار در 5 دقیقه و شاخص پوندرال نوزادان در زمان تولد، اندازه گیری خواهد شد.
General information
1
1
1
1
1
1
N/A
2
na2
50
60
5060
2014-02-20, 1392/12/01
2014-02-04, 1392/11/15
2014-02-2004 00:00:00
2014-03-20, 1392/12/29
2014-03-04, 1392/12/13
2014-03-2004 00:00:00
Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation
Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation
نان باردار 40-18 ساله؛ مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
نان باردار 40-18 ساله؛ مبتلا به دیابت بارداری (GDM) در هفته 28-24 بارداری
Multiple gestation,
Major fetal anomalies
Current illicit drug use
Continuous daily Ca and/or vitamin D intake since last menstrual period
Insulin-dependent diabetes
Smoking
History of kidney stones
Multiple gestation, Major fetal anomalies Current illicit drug use Continuous daily Ca and/or vitamin D intake since last menstrual period Insulin-dependent diabetes Smoking History of kidney stones
بارداری های متعدد
ناهنجاری عمده در جنین
استفاده از مواد مخدر
به طور مداوم روزانه دریافت ویتامین D و یا کلسیم از آخرین دوره قاعدگی
دیابت وابسته به انسولین
سیگار کشیدن
سابقه سنگ کلیه
بارداری های متعدد ناهنجاری عمده در جنین استفاده از مواد مخدر به طور مداوم روزانه دریافت ویتامین D و یا کلسیم از آخرین دوره قاعدگی دیابت وابسته به انسولین سیگار کشیدن سابقه سنگ کلیه
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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 either vitamin D plus calcium supplements (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 either vitamin D plus calcium 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 هفته بارداری، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین D و کلسیم (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.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و هفته بارداری، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین D و کلسیم (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 the maternity clinics 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.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the maternity clinics 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 زایمان 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.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک زایمان 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
Newborn's head circumference
Newborn's weight
Newborn's head circumferenceweight
دور سر نوزادان
وزن نوزادان
دور سروزن نوزادان
Tape
Scale
TapeScale
متر نواری
ترازو
متر نواریترازو
#2
Newborn's weight
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Newborn's weight
وزن نوزادان
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وزن نوزادان
Delivery time
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Delivery time
زمان زایمان
empty
زمان زایمان
Scale
empty
Scale
ترازو
empty
ترازو
#3
Ponderal index
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Ponderal index
پوندرال ایندکس
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پوندرال ایندکس
Delivery time
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Delivery time
زمان زایمان
empty
زمان زایمان
Calculation
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Calculation
محاسبه
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محاسبه
#4
Polyhydramnios
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Polyhydramnios
پلی هیدروآمونیوس
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پلی هیدروآمونیوس
End-of-trial
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End-of-trial
انتهای مداخله
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انتهای مداخله
Sonographic
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Sonographic
سونوگرافی
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سونوگرافی
Secondary outcomes
#1
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Newborn's head circumference
Newborn's head circumference
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دور سر نوزادان
دور سر نوزادان
empty
Delivery time
Delivery time
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زمان زایمان
زمان زایمان
empty
Tape
Tape
empty
متر نواری
متر نواری
#2
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Ponderal index
Ponderal index
empty
پوندرال ایندکس
پوندرال ایندکس
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
Calculation
Calculation
empty
محاسبه
محاسبه
#3
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Polyhydramnios
Polyhydramnios
empty
پلی هیدروآمونیوس
پلی هیدروآمونیوس
empty
End-of-trial
End-of-trial
empty
انتهای مداخله
انتهای مداخله
empty
Sonographic
Sonographic
empty
سونوگرافی
سونوگرافی
#4
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Newborn's length
Newborn's length
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قد نوزادان
قد نوزادان
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
Tape
Tape
empty
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
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#6
empty
Apgar score
Apgar score
empty
عدد آپگار
عدد آپگار
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
Clinical observation
Clinical observation
empty
مشاهده بالینی
مشاهده بالینی
#7
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Newborns' hypoglycemia
Newborns' hypoglycemia
empty
هیپوگلیسمی نوزادان تازه متولد شده
هیپوگلیسمی نوزادان تازه متولد شده
empty
After delivery
After delivery
empty
بعد زایمان
بعد زایمان
empty
Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#8
empty
Preterm delivery
Preterm delivery
empty
زایمان زودرس
زایمان زودرس
empty
After delivery
After delivery
empty
بعد زایمان
بعد زایمان
empty
Medical record
Medical record
empty
پرونده پزشکی
پرونده پزشکی
#9
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Maternal pre-eclampsia
Maternal pre-eclampsia
empty
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
#10
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Maternal hospitalization
Maternal hospitalization
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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
#11
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: 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: Maternity clinics affiliated to Arak University of Medical Sciences
Name of recruitment center - Persian: کلینیک زایمان وابسته به دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Maryam Karamali
Full name of responsible person - Persian: مریم کرمعلی
Street address - English: Imam street, Arak
Street address - Persian: اراک، خیابان امام
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: Kossar ClinicMaternity clinics affiliated to Arak University of Medical Sciences Name of recruitment center - Persian: کلینیک کوثرزایمان وابسته به دانشگاه علوم پزشکی اراک Full name of responsible person - English: Maryam Karamali Full name of responsible person - Persian: مریم کرمعلی Street address - English: Imam street, Arak Street address - Persian: اراک، خیابان امام 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: 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: Mohammad Rafiei
Full name of responsible person - Persian: محمد رفیعی
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: 3848176941
Phone: +98 86 3417 3639
Fax:
Email: research@arakmu.ac.ir
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 KaramaliMohammad Rafiei Full name of responsible person - Persian: مریم کرمعلیمحمد رفیعی 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: 3848176941 Phone: +98 86 3417 3639 Fax: Email: research@arakmu.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: Nutritionist
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_r@yahoo.com
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: Nutritionist 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_r@yahoo.com 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:
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: 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: 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 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: 034 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: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.irasemi_r@yahoo.comkaums.ac.ir 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:
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: Nutritionist
Position - Persian: متخصص تغیه
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 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: Nutritionist Position - Persian: متخصص تغیه 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.irasemi_r@yahoo.comkaums.ac.ir 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 vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes.
60 patients with GDM among pregnant women of eligible and referred to maternity Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. Exclusion criteria will be multiple gestation, major fetal anomalies, current illicit drug use, continuous daily Ca and/or vitamin D intake since last menstrual period, insulin-dependent diabetes, smoking and history of kidney stones.
Intervention groups
Patients will be assigned to receive either vitamin D plus calcium supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201407115623N23
Registration date:2014-07-21, 1393/04/30
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:1
Registration date
2014-07-21, 1393/04/30
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
2014-02-04, 1392/11/15
Expected recruitment end date
2014-03-04, 1392/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D plus calcium co-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 weeks' gestation
Exclusion criteria:
Multiple gestation,
Major fetal anomalies
Current illicit drug use
Continuous daily Ca and/or vitamin D intake since last menstrual period
Insulin-dependent diabetes
Smoking
History of kidney stones
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
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 either vitamin D plus calcium 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 the maternity clinics 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
3848176941
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
92-158-19
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
Newborn's weight
Timepoint
Delivery time
Method of measurement
Scale
Secondary outcomes
1
Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape
2
Description
Ponderal index
Timepoint
Delivery time
Method of measurement
Calculation
3
Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonographic
4
Description
Newborn's length
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
Newborns' hypoglycemia
Timepoint
After delivery
Method of measurement
Enzymatic kit
8
Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record
9
Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record
10
Description
Maternal hospitalization
Timepoint
After delivery
Method of measurement
Medical record
11
Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record
Intervention groups
1
Description
Intervention group: Vitamin D3 capsule, 50000 IU, every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Calcium tablet, 500 mg, two times a day for 6 weeks orally.
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule, every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs
4
Description
Control group: Placebo tablet, two times a day for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity clinics affiliated to Arak University of Medical Sciences
Full name of responsible person
Maryam Karamali
Street address
Imam street, 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
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiei
Street address
Vice-chancellor for Education and Research, 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?
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
Nutritionist
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_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, 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
Nutritionist
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