Comparison of two therapeutic regimens Vitamin D3 deficiency in the first trimester of pregnancy on the level of vitamin D3 in the second trimester of pregnancy
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Protocol summary
The aim of the study: obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women;Inclusioncriteria:Serum Vitamin D level is less than 30 ng/ml ; Exclusion criteria: the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth ) ;Sampling method and sample size estimation : An in probable and available sampling method. For each treatment group, 100 patients and 200 people .Treatment will be done in two groups: Group A, Oral treatment of Vitamin D in the form of perl 50,000 units once a week for up to 10 weeks.The second group, Group B, includes oral treatment in the form of a Vitamin D3 tablet of 1000 units per day for up to 10 week. This study is intended for a period of one year.
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The aim of the study: obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women;Inclusioncriteria:Serum Vitamin D level is less than 30 ng/ml ; Exclusion criteria: the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth ) ;Sampling method and sample size estimation : An in probable and available sampling method. For each treatment group, 100 patients and 200 people .Treatment will be done in two groups: Group A, Oral treatment of Vitamin D in the form of perl 50,000 units once a week for up to 10 weeks.The second group, Group B, includes oral treatment in the form of a Vitamin D3 tablet of 1000 units per day for up to 10 week. This study is intended for a period of one year.
هدف از مطالعه : بدست آوردن چشم اندازی از تاثیر روشهای مختلف درمانی کمبود ویتامین D در بارداری وانتخاب روش مناسب برای درمان مادر باردار ؛ معیار ورورد: - برگه ازمایش ویتامین D3 کمتر از30ng/ml که نشان دهنده کمبود ویتامین D3 میباشد
معیار خروج : وقوع هر گونه عارضه مرتبط با درمان ( تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان ) ؛ جمعیت مورد مطالعه : تمامی زنان باردار واقع 42-18 ساله در سه ماهه اول بارداری که کمبود ویتامین D دارند ؛ روش نمونه‌گیری و برآورد حجم نمونه : به روش نمونه‌گیری غیر محتمل و در دسترس بوده است که برای هر گروه درمان مورد مطالعه حدود 100نفر و در کل 200 نفر لازم بوده است. درمان در دو گروه انجام خواهد شد : گروه درمانی الف که درمان خوراکی ویتامین به شکل پرل D3 50000 واحدی هفته ای یکبار تا 10 هفته می باشد. گروه دوم :گروه درمانی ب هست که شامل درمان خوراکی به شکل قرص ویتامین D3 1000 واحدی روزانه تا 10 هفته می باشد .این مطالعه در بازه زمانی یکسال در نظر گرفته شده است.
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هدف از مطالعه : بدست آوردن چشم اندازی از تاثیر روشهای مختلف درمانی کمبود ویتامین D در بارداری وانتخاب روش مناسب برای درمان مادر باردار ؛ معیار ورورد: - برگه ازمایش ویتامین D3 کمتر از30ng/ml که نشان دهنده کمبود ویتامین D3 میباشد معیار خروج : وقوع هر گونه عارضه مرتبط با درمان ( تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان ) ؛ جمعیت مورد مطالعه : تمامی زنان باردار واقع 42-18 ساله در سه ماهه اول بارداری که کمبود ویتامین D دارند ؛ روش نمونه‌گیری و برآورد حجم نمونه : به روش نمونه‌گیری غیر محتمل و در دسترس بوده است که برای هر گروه درمان مورد مطالعه حدود 100نفر و در کل 200 نفر لازم بوده است. درمان در دو گروه انجام خواهد شد : گروه درمانی الف که درمان خوراکی ویتامین به شکل پرل D3 50000 واحدی هفته ای یکبار تا 10 هفته می باشد. گروه دوم :گروه درمانی ب هست که شامل درمان خوراکی به شکل قرص ویتامین D3 1000 واحدی روزانه تا 10 هفته می باشد .این مطالعه در بازه زمانی یکسال در نظر گرفته شده است.
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Obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women
Obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women
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بدست آوردن چشم اندازی از تاثیر روشهای مختلف درمانی کمبود ویتامین D در بارداری وانتخاب روش مناسب برای درمان مادر باردار
بدست آوردن چشم اندازی از تاثیر روشهای مختلف درمانی کمبود ویتامین D در بارداری وانتخاب روش مناسب برای درمان مادر باردار
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Pregnant mothers who referred to the gynecologic clinic were randomly assigned to two oral treatment groups A (vitamin D3 in the form of a Perl 50,000 units once a week for up to 10 weeks) and group B (oral treatment in the form of a pill of vitamins D3 was divided into 1000 units per day for up to 10 weeks), and only the laboratory results were blind to hide the intervention group.
Pregnant mothers who referred to the gynecologic clinic were randomly assigned to two oral treatment groups A (vitamin D3 in the form of a Perl 50,000 units once a week for up to 10 weeks) and group B (oral treatment in the form of a pill of vitamins D3 was divided into 1000 units per day for up to 10 weeks), and only the laboratory results were blind to hide the intervention group.
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مادران باردار که به کلینیک زنان وزایمان مراجعه کرده بودند به روش نمونه‌گیری غیر محتمل و در دسترس به دو گروه درمانی خوراکی الف( ویتامین D3 به شکل پرل 50000 واحدی هفته ای یکبار تا 10 هفته ) و گروه درمانی ب (درمان خوراکی به شکل قرص ویتامین D3 به شکل قرص 1000واحدی روزانه تا 10 هفته) تقسیم شدند و برای پنهان سازی گروه مداخله فقط نتایج آزمایشگاه کور بود .
مادران باردار که به کلینیک زنان وزایمان مراجعه کرده بودند به روش نمونه‌گیری غیر محتمل و در دسترس به دو گروه درمانی خوراکی الف( ویتامین D3 به شکل پرل 50000 واحدی هفته ای یکبار تا 10 هفته ) و گروه درمانی ب (درمان خوراکی به شکل قرص ویتامین D3 به شکل قرص 1000واحدی روزانه تا 10 هفته) تقسیم شدند و برای پنهان سازی گروه مداخله فقط نتایج آزمایشگاه کور بود .
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A study was conducted on mothers who vitamin D deficiency and they were referred to a gynecology and obstetric clinic for prenatal care. They were individually non-randomly divided into two groups of oral vitamin D treatment groups of 1000 and 50,000 units. Serum levels were blinded in the laboratory to hide the type of treatment.
A study was conducted on mothers who vitamin D deficiency and they were referred to a gynecology and obstetric clinic for prenatal care. They were individually non-randomly divided into two groups of oral vitamin D treatment groups of 1000 and 50,000 units. Serum levels were blinded in the laboratory to hide the type of treatment.
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مطالعه بر روی مادرانی که کمبود ویتامین D داشتند و برای انجام مراقبتهای بارداری به کلینیک زنان وزایمان مراجعه کرده و به صورت اختصاصی غیر تصادفی در دو گروه درمانی خوراکی ویتامین د 1000 و 50000 واحدی قرار گرفتند. برای پنهان بودن نوع درمان بررسی سطح سرمی در آزمایشگاه کور بود.
مطالعه بر روی مادرانی که کمبود ویتامین D داشتند و برای انجام مراقبتهای بارداری به کلینیک زنان وزایمان مراجعه کرده و به صورت اختصاصی غیر تصادفی در دو گروه درمانی خوراکی ویتامین د 1000 و 50000 واحدی قرار گرفتند. برای پنهان بودن نوع درمان بررسی سطح سرمی در آزمایشگاه کور بود.
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Inclusion criteria, serum Vitamin D level is less than 30 ng/ml . Exclusion criteria,the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth )
Inclusion criteria, serum Vitamin D level is less than 30 ng/ml . Exclusion criteria,the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth )
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معیار ورورد ،آزمایش سطح سرمی ویتامین D3 کمتر از 30 نانو گرم بر میلی لیتر که نشان دهنده کمبود ویتامین D3 می باشد
معیار خروج ،وقوع هر گونه عارضه مرتبط با درمان ( تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان )
معیار ورورد ،آزمایش سطح سرمی ویتامین D3 کمتر از 30 نانو گرم بر میلی لیتر که نشان دهنده کمبود ویتامین D3 می باشد معیار خروج ،وقوع هر گونه عارضه مرتبط با درمان ( تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان )
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The intervention group was a pregnant mothers with vitamin D deficiency who received a dose of 50,000 units of vitamin D3 once a week. Control group was pregnant women with vitamin D deficiency who received a dose of 1000 unit per day.
Both groups received these doses from week 14 of pregnancy to ten weeks.
The intervention group was a pregnant mothers with vitamin D deficiency who received a dose of 50,000 units of vitamin D3 once a week. Control group was pregnant women with vitamin D deficiency who received a dose of 1000 unit per day. Both groups received these doses from week 14 of pregnancy to ten weeks.
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گروه مداخله ، مادران باردار با کمبود ویتامین د بودند که دوز 50000 واحدی ویتامین د3 را هفته ای یک بار دریافت کردند گروه کنترل هم مادران باردار باکمبود ویتامین د بودند که دوز 1000 واحدی را روزانه دریافت کردند هر دو گروه از هفته 14 بارداری تا ده هفته این دوزها را دریافت کردند.
گروه مداخله ، مادران باردار با کمبود ویتامین د بودند که دوز 50000 واحدی ویتامین د3 را هفته ای یک بار دریافت کردند گروه کنترل هم مادران باردار باکمبود ویتامین د بودند که دوز 1000 واحدی را روزانه دریافت کردند هر دو گروه از هفته 14 بارداری تا ده هفته این دوزها را دریافت کردند.
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Study of Serum levels of vitamin D3 in both groups with dose of 1000 and 50000 units of vitamin D3 before and after treatment .
Study of Serum levels of vitamin D3 in both groups with dose of 1000 and 50000 units of vitamin D3 before and after treatment .
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بررسی سطح سرمی ویتامین D3 در دو گروه قبل و بعد از درمان با دوز 1000 و 50000 واحدی ویتامین D3
بررسی سطح سرمی ویتامین D3 در دو گروه قبل و بعد از درمان با دوز 1000 و 50000 واحدی ویتامین D3
General information
Comparative dose of 1000 unite and 50000 unite Vitamin D
VDD
Comparative dose of 1000 unite and 50000 unite Vitamin DVDD
Randomized
Not randomized
randnrand
Not blinded
Single blinded
notblsingl
1
1
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220
220
2016-07-20, 1395/04/30
2016-06-19, 1395/03/30
2016-0706-2019 00:00:00
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2016-07-20, 1395/04/30
2016-07-20 00:00:00
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2017-07-21, 1396/04/30
2017-07-21 00:00:00
Theraputic regimens for Vitamin D3 deficiency
Therapeutic regimens for Vitamin D3 deficiency
TheraputicTherapeutic regimens for Vitamin D3 deficiency
رژیم درمانی کمبود ویتامین د در حاملگی
رژیم درمانی کمبود ویتامین D3 در حاملگی
رژیم درمانی کمبود ویتامین دD3 در حاملگی
A Comparative study of the effects of two Theraputic regimens for Vitamin D3 deficiency in the first trimester of pregnancy on Vitamin D3 levels in 24-28 weeks of gestation
Comparison of two therapeutic regimens Vitamin D3 deficiency in the first trimester of pregnancy on the level of vitamin D3 in the second trimester of pregnancy
A Comparative study of the effectsComparison of two Theraputictherapeutic regimens for Vitamin D3 deficiency in the first trimester of pregnancy on Vitaminthe level of vitamin D3 levels in 24-28 weeksthe second trimester of gestationpregnancy
بررسی مقایسه ای دو رژیم درمانی کمبود ویتامین D3در سه ماهه اول بارداری بر سطح ویتامین D3در ۲۴-۲۸ هفته بارداری
مقایسه دو رژیم درمانی کمبود ویتامین D3 در سه ماهه اول بارداری بر سطح ویتامین D3 در سه ماهه دوم بارداری
بررسی مقایسه ای دو رژیم درمانی کمبود ویتامین D3درD3 در سه ماهه اول بارداری بر سطح ویتامین D3در ۲۴-۲۸ هفتهD3 در سه ماهه دوم بارداری
Serum Vitamin D level is less than 30 ng / ml
Gestational age less than 14 weeks
Age 18-42 years
Not chronic disease, impaired absorption and metabolism of food
Single pregnancy
Not receiving any supplement except multivitamins to 400 unite Vitamin D3, folic acid, iron and calcium with 400 units Vitamin D3
Having Iranian nationality
Serum Vitamin D level is less than 30 ng / ml Gestational age less than 14 weeks Age 18-42 years Not chronic disease, impaired absorption and metabolism of food Single pregnancy Not receiving any supplement except multivitamins to 400 unite Vitamin D3, folic acid, iron and calcium with 400 units Vitamin D3 Having Iranian nationality
آزمایش سطح سرمی ویتامین D3 کمتر از30ng/ml که نشان دهنده کمبود ویتامین D3 می باشد
سن بارداری کمتر از 14 هفته
محدوده سنی 42-18 سال
عدم وجود بیماری مزمن اختلال جذب و متابولیسم مواد غذایی
بارداری تک قلو
عدم دریافت هرگونه مکمل بجز مصرف مولتی ویتامین حاوی 400 واحد ویتامین D و آهن بارداری واسید فولیک,وکلسیم تا 400 واحد
دارا بودن ملیت ایرانی
آزمایش سطح سرمی ویتامین D3 کمتر از30ng/ml که نشان دهنده کمبود ویتامین D3 می باشد سن بارداری کمتر از 14 هفته محدوده سنی 42-18 سال عدم وجود بیماری مزمن اختلال جذب و متابولیسم مواد غذایی بارداری تک قلو عدم دریافت هرگونه مکمل بجز مصرف مولتی ویتامین حاوی 400 واحد ویتامین D و آهن بارداری واسید فولیک,وکلسیم تا 400 واحد دارا بودن ملیت ایرانی
Unwillingness to continue participating in the study
The occurrence of any complication related to treatment (nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth)
Do not use the correct medicine
People who have special diets, including vegetarian diet, etc.
Unwillingness to continue participating in the study The occurrence of any complication related to treatment (nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth) Do not use the correct medicine People who have special diets, including vegetarian diet, etc.
عدم تمایل به ادامه شرکت در مطالعه
وقوع هر گونه عارضه مرتبط با درمان (تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان )
عدم مصرف به موقع دارو
افرادیکه رژیم های غذایی خاص دارند ازجمله رژیم گیاهخواری وغیره
عدم تمایل به ادامه شرکت در مطالعه وقوع هر گونه عارضه مرتبط با درمان (تهوع واستفراغ, خستگی ,ضعف , سردرد ,پر ادراری ,خشکی دهان ) عدم مصرف به موقع دارو افرادیکه رژیم های غذایی خاص دارند ازجمله رژیم گیاهخواری وغیره
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Clinical lab ,it was blind. According to the review of serum levels of vitamin D, it did not know what type of treatment they would receive
Clinical lab ,it was blind. According to the review of serum levels of vitamin D, it did not know what type of treatment they would receive
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آزمایشگاه بالینی کور بود که برای بررسی سطح سرمی ویتامین D نمیدانست مراجعین چه نوع درمانی دریافت کرده اند
آزمایشگاه بالینی کور بود که برای بررسی سطح سرمی ویتامین D نمیدانست مراجعین چه نوع درمانی دریافت کرده اند
Primary outcomes
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Study of Vitamin D levels
Check of the serum levels of vitamin D
StudyCheck of Vitaminthe serum levels of vitamin D levels
بررسی سطح ویتامین د
بررسی سطح سرمی ویتامین د
بررسی سطح سرمی ویتامین د
Recruitment centers
#1
Name of recruitment center - English: Clinic of Gynecology and Obstetrics
Name of recruitment center - Persian: کلینیک زنان وزایمان
Full name of responsible person - English: Farahnaz.Rostami
Full name of responsible person - Persian: فرحناز رستمی
Street address - English:
Street address - Persian:
City - English: Tehrqan
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Clinic of Gynecology and Obstetric
Name of recruitment center - Persian: کلینیک زنان وزایمان
Full name of responsible person - English: Farahnaz. rostami
Full name of responsible person - Persian: فرحناز رستمی
Street address - English: 14115-111,Post box,Intersection Al Ahmad Street, Shahid Chamran Highway, Tehran ,Iran
Street address - Persian: صندوق پستی 14115-111،تقاطع خیابان آل احمد ، بزرگراه شهید چمران ،تهران ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 0000
Fax:
Email: frostami22@yahoo.com
Web page address:
Name of recruitment center - English: Clinic of Gynecology and ObstetricsObstetric Name of recruitment center - Persian: کلینیک زنان وزایمان Full name of responsible person - English: Farahnaz.RostamiFarahnaz. rostami Full name of responsible person - Persian: فرحناز رستمی Street address - English: 14115-111,Post box,Intersection Al Ahmad Street, Shahid Chamran Highway, Tehran ,Iran Street address - Persian: صندوق پستی 14115-111،تقاطع خیابان آل احمد ، بزرگراه شهید چمران ،تهران ایران City - English: TehrqanTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713116 Phone: +98 21 8288 0000 Fax: Email: frostami22@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University of Medical Science, Tehran
Name of organization / entity - Persian: تهران دانشکده پزشکی ,دانشگاه تربیت مدرس
Full name of responsible person - English: Doctor Yaghob Fatollahi
Full name of responsible person - Persian: دکتریعقوب فتح الهی
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی , 111-14115
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University of Medical Science, Tehran
Name of organization / entity - Persian: تهران دانشکده پزشکی ,دانشگاه تربیت مدرس
Full name of responsible person - English: Doctor Yaghob Fatollahi
Full name of responsible person - Persian: دکتریعقوب فتح الهی
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی , 111-14115
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: :1411713116
Phone: +98 21 8288 2009
Fax:
Email: fatolahi@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University of Medical Science, Tehran Name of organization / entity - Persian: تهران دانشکده پزشکی ,دانشگاه تربیت مدرس Full name of responsible person - English: Doctor Yaghob Fatollahi Full name of responsible person - Persian: دکتریعقوب فتح الهی Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی , 111-14115 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: :1411713116 Phone: +98 21 8288 2009 Fax: Email: fatolahi@modares.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University of Medicai Science
Name of organization / entity - Persian: دانشکده پزشکی دانشگاه تربیت مدرس
Full name of responsible person - English: Farahnaz Rostami
Full name of responsible person - Persian: فرحناز رستمی
Position - English: Master / Student
Position - Persian: کارشناس ارشد/دانشجو
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران ,بزرگراه شهید چمران ,تقاطع آل احمد ,صندوق پستی ,111-14115
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6690 1515
Mobile: +98 912 310 4044
Fax:
Email: farahnaz.rostami@modares.ac.ir and frostami22@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University of Medicai Science
Name of organization / entity - Persian: دانشکده پزشکی دانشگاه تربیت مدرس
Full name of responsible person - English: Farahnaz Rostami
Full name of responsible person - Persian: فرحناز رستمی
Position - English: Master / Student
Position - Persian: کارشناس ارشد/دانشجو
Latest degree: master
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران ,بزرگراه شهید چمران ,تقاطع آل احمد ,صندوق پستی ,111-14115
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 6690 1515
Mobile: +98 912 310 4044
Fax:
Email: farahnaz.rostami@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University of Medicai Science Name of organization / entity - Persian: دانشکده پزشکی دانشگاه تربیت مدرس Full name of responsible person - English: Farahnaz Rostami Full name of responsible person - Persian: فرحناز رستمی Position - English: Master / Student Position - Persian: کارشناس ارشد/دانشجو Latest degree: master Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran Street address - Persian: تهران ,بزرگراه شهید چمران ,تقاطع آل احمد ,صندوق پستی ,111-14115 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411713116 Phone: +98 21 6690 1515 Mobile: +98 912 310 4044 Fax: Email: farahnaz.rostami@modares.ac.ir and frostami22@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University of Medical Science
Name of organization / entity - Persian: دانشکده پزشکی داشگاه تربیت مدرس
Full name of responsible person - English: Doctor Sedigheh Hantoshzadeh
Full name of responsible person - Persian: دکتر صدیقه حنطوش زاده
Position - English: Professor
Position - Persian: فوق تخصص و استاد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران, تقاطع آل احمد, صندوق پستی 111-14115
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6690 1515
Mobile: +98 912 127 1209
Fax:
Email: farahnaz.rostami@modares.ac.ir and frostami22@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Doctor Sedigheh Hantoshzadeh
Full name of responsible person - Persian: دکتر صدیقه حنطوش زاده
Position - English: Professor
Position - Persian: فوق تخصص و استاد
Latest degree: sub_specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران, تقاطع آل احمد, صندوق پستی 111-14115
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3439123900
Phone: +98 21 6690 1515
Mobile: +98 912 127 1209
Fax:
Email: Hantoushzadeh@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat ModaresTehran University of Medical Science Name of organization / entity - Persian: دانشکدهدانشگاه علوم پزشکی داشگاه تربیت مدرستهران Full name of responsible person - English: Doctor Sedigheh Hantoshzadeh Full name of responsible person - Persian: دکتر صدیقه حنطوش زاده Position - English: Professor Position - Persian: فوق تخصص و استاد Latest degree: sub_specialist Area of specialty/work: 049 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran Street address - Persian: تهران , بزرگراه شهید چمران, تقاطع آل احمد, صندوق پستی 111-14115 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3439123900 Phone: +98 21 6690 1515 Mobile: +98 912 127 1209 Fax: Email: farahnaz.rostamiHantoushzadeh@modares.ac.ir and frostami22@yahoo.comtums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares of Medical Science
Name of organization / entity - Persian: دانشکده پزشکی ,دانشگاه تربیت مدرس
Full name of responsible person - English: Doctor Lida Moghadambanaem
Full name of responsible person - Persian: دکتر لیدا مقدم بنائم
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad street, Shahid Chamran highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی 111-14115
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1493675683
Phone: +98 21 8288 3857
Mobile: +98 912 203 1264
Fax:
Email: moghaddamb@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares of Medical Science
Name of organization / entity - Persian: دانشکده پزشکی ,دانشگاه تربیت مدرس
Full name of responsible person - English: Doctor Lida Moghadambanaem
Full name of responsible person - Persian: دکتر لیدا مقدم بنائم
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: med_doctor
Area of specialty/work: 88
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 14115-111, Post box, Intersection Al Ahmad street, Shahid Chamran highway , Tehran
Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی 111-14115
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1493675683
Phone: +98 21 8288 3857
Mobile: +98 912 203 1264
Fax:
Email: moghaddamb@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares of Medical Science Name of organization / entity - Persian: دانشکده پزشکی ,دانشگاه تربیت مدرس Full name of responsible person - English: Doctor Lida Moghadambanaem Full name of responsible person - Persian: دکتر لیدا مقدم بنائم Position - English: Associate Professor Position - Persian: دانشیار Latest degree: med_doctor Area of specialty/work: 088 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 14115-111, Post box, Intersection Al Ahmad street, Shahid Chamran highway , Tehran Street address - Persian: تهران , بزرگراه شهید چمران , تقاطع خیابان آل احمد, صندوق پستی 111-14115 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1493675683 Phone: +98 21 8288 3857 Mobile: +98 912 203 1264 Fax: Email: moghaddamb@modares.ac.ir Web page address:
Sharing plan
no
no
yes
yes
yes
yes
yes
yes
yes
yes
na
na
na
na
empty
All participants have signed a written consent to participate in this study and all of their information will not be publish elsewhere
All participants have signed a written consent to participate in this study and all of their information will not be publish elsewhere
empty
از تمامی شرکت کنندگان امضای کتبی گرفته شده است که رضایت شرکت در مطالعه را دارند وکلیه اطلاعات آنها در جای دیگری درج نخواهد شد
از تمامی شرکت کنندگان امضای کتبی گرفته شده است که رضایت شرکت در مطالعه را دارند وکلیه اطلاعات آنها در جای دیگری درج نخواهد شد
empty
Statistical information data
Statistical information data
empty
اطلاعات مر بوط داده های آماری
اطلاعات مر بوط داده های آماری
empty
Starting the access period from 1398 after printing
Starting the access period from 1398 after printing
empty
شروع دوره دسترسی از سال 1398 بعد از پس از چاپ
شروع دوره دسترسی از سال 1398 بعد از پس از چاپ
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Researchers working in academic and academic institutions
Researchers working in academic and academic institutions
empty
محققین شاغل در موسسات دانشگاهی وعلمی
محققین شاغل در موسسات دانشگاهی وعلمی
empty
Qualitative and quantitative data is permitted for various analyzes and the use of documentation is permitted in health surveys.
Qualitative and quantitative data is permitted for various analyzes and the use of documentation is permitted in health surveys.
empty
دادهای کیفی و کمی مطالعه برای آنالیز های مختلف مجاز است و در بررسی های سلامتی استفاده از مستندات مجاز است
دادهای کیفی و کمی مطالعه برای آنالیز های مختلف مجاز است و در بررسی های سلامتی استفاده از مستندات مجاز است
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1. farahnaz.rostami@modares.ac.ir Phone number 09023104044 Mrs Rostamiand 2.Thesis Departmen, Library of Tarbiat Modares University
1. farahnaz.rostami@modares.ac.ir Phone number 09023104044 Mrs Rostamiand 2.Thesis Departmen, Library of Tarbiat Modares University
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1 .farahnaz.rostami@modares ac .ir خانم رستمی شماره تلفن 09023104044 و 2. کتابخانه دانشگاه تربیت مدرس ، بخش پایان نامه ها
1 .farahnaz.rostami@modares ac .ir خانم رستمی شماره تلفن 09023104044 و 2. کتابخانه دانشگاه تربیت مدرس ، بخش پایان نامه ها
empty
After receipt of an email or text message from the researcher, within two months, the document or file will be sent.
After receipt of an email or text message from the researcher, within two months, the document or file will be sent.
empty
بعد از دریافت ایمیل یا پیامک تلفنی از سوی محقق در بازه زمانی تقریبا دو ماه مستندات یا فایل ارسال می شود
بعد از دریافت ایمیل یا پیامک تلفنی از سوی محقق در بازه زمانی تقریبا دو ماه مستندات یا فایل ارسال می شود
Protocol summary
Study aim
Obtaining an overview of the effects of various therapies on vitamin D deficiency in pregnancy and choosing a suitable method for the treatment of pregnant women
Design
Pregnant mothers who referred to the gynecologic clinic were randomly assigned to two oral treatment groups A (vitamin D3 in the form of a Perl 50,000 units once a week for up to 10 weeks) and group B (oral treatment in the form of a pill of vitamins D3 was divided into 1000 units per day for up to 10 weeks), and only the laboratory results were blind to hide the intervention group.
Settings and conduct
A study was conducted on mothers who vitamin D deficiency and they were referred to a gynecology and obstetric clinic for prenatal care. They were individually non-randomly divided into two groups of oral vitamin D treatment groups of 1000 and 50,000 units. Serum levels were blinded in the laboratory to hide the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria, serum Vitamin D level is less than 30 ng/ml . Exclusion criteria,the occurrence of any complication related to treatment ( nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth )
Intervention groups
The intervention group was a pregnant mothers with vitamin D deficiency who received a dose of 50,000 units of vitamin D3 once a week. Control group was pregnant women with vitamin D deficiency who received a dose of 1000 unit per day.
Both groups received these doses from week 14 of pregnancy to ten weeks.
Main outcome variables
Study of Serum levels of vitamin D3 in both groups with dose of 1000 and 50000 units of vitamin D3 before and after treatment .
General information
Reason for update
Acronym
VDD
IRCT registration information
IRCT registration number:IRCT2016040527227N1
Registration date:2017-07-10, 1396/04/19
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:2
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Dr. Sedigheh Hantoshzadeh
Name of organization / entity
Tarbiat Modares University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 1515
Email address
farahnaz.rostami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares of Medical Science
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2016-07-20, 1395/04/30
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
empty
Scientific title
Comparison of two therapeutic regimens Vitamin D3 deficiency in the first trimester of pregnancy on the level of vitamin D3 in the second trimester of pregnancy
Public title
Therapeutic regimens for Vitamin D3 deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Serum Vitamin D level is less than 30 ng / ml
Gestational age less than 14 weeks
Age 18-42 years
Not chronic disease, impaired absorption and metabolism of food
Single pregnancy
Not receiving any supplement except multivitamins to 400 unite Vitamin D3, folic acid, iron and calcium with 400 units Vitamin D3
Having Iranian nationality
Exclusion criteria:
Unwillingness to continue participating in the study
The occurrence of any complication related to treatment (nausea, vomiting, fatigue, weakness, headache, frequent urination, dry mouth)
Do not use the correct medicine
People who have special diets, including vegetarian diet, etc.
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
200
Actual sample size reached:
220
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Clinical lab ,it was blind. According to the review of serum levels of vitamin D, it did not know what type of treatment they would receive
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modarres University of Medical Science
Street address
14115-111, Post box , Tarbiat Modares University, Intersection Al Ahmad Street , Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.TMU.REC.1395.368
Health conditions studied
1
Description of health condition studied
Vitamine D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Check of the serum levels of vitamin D
Timepoint
First Trimester and Second Trimester
Method of measurement
Blood Exam
Secondary outcomes
1
Description
Delete
Timepoint
Delete
Method of measurement
Delete
Intervention groups
1
Description
Group Therapy A: Oral Treatment of vitamin D perl 50,000 units once a week to 10 weeks
Category
Treatment - Drugs
2
Description
Group Therapy B, Oral Tretment of vitamin D
Tablet 1000 unite daily for 10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Gynecology and Obstetric
Full name of responsible person
Farahnaz. rostami
Street address
14115-111,Post box,Intersection Al Ahmad Street, Shahid Chamran Highway, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
frostami22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Medical Science, Tehran
Full name of responsible person
Doctor Yaghob Fatollahi
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Province
Tehran
Postal code
:1411713116
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
52د/640
Grant code / Reference number
1273432
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University of Medical Science, Tehran
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
Tarbiat Modares University of Medicai Science
Full name of responsible person
Farahnaz Rostami
Position
Master / Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 6690 1515
Fax
Email
farahnaz.rostami@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical
Full name of responsible person
Doctor Sedigheh Hantoshzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
14115-111, Post box, Intersection Al Ahmad Street, Shahid Chamran Highway , Tehran
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 6690 1515
Fax
Email
Hantoushzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares of Medical Science
Full name of responsible person
Doctor Lida Moghadambanaem
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
14115-111, Post box, Intersection Al Ahmad street, Shahid Chamran highway , Tehran
City
Tehran
Province
Tehran
Postal code
1493675683
Phone
+98 21 8288 3857
Fax
Email
moghaddamb@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All participants have signed a written consent to participate in this study and all of their information will not be publish elsewhere
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Statistical information data
When the data will become available and for how long
Starting the access period from 1398 after printing
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Qualitative and quantitative data is permitted for various analyzes and the use of documentation is permitted in health surveys.
From where data/document is obtainable
1. farahnaz.rostami@modares.ac.ir Phone number 09023104044 Mrs Rostamiand 2.Thesis Departmen, Library of Tarbiat Modares University
What processes are involved for a request to access data/document
After receipt of an email or text message from the researcher, within two months, the document or file will be sent.