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Protocol summary
Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients with diabetic hemodialysis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic hemodialysis and aged 18 to 80 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic hemodialysis of eligible and referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamin D supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Insulin resistance (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients with diabetic hemodialysis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic hemodialysis and aged 18 to 80 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic hemodialysis of eligible and referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamin D supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Insulin resistance (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به همودیالیز دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ویتامین D (گروه مداخله:30 نفر) و پلاسبو (گروه کنترل: 30 نفر) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مقاومت به انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به همودیالیز دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ویتامین D (گروه مداخله:30 نفر) و پلاسبو (گروه کنترل: 30 نفر) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مقاومت به انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients with diabetic hemodialysis.
Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients with diabetic hemodialysis.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر پروفایل های متابولیک در بیماران مبتلا به همودیالیز دیابتیک است.
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Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive vitamin D supplement (n=30) or placebo (n=30).
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive vitamin D supplement (n=30) or placebo (n=30).
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طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
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Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
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Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Taking vitamin D, antioxidant and/or anti-inflammatory supplements, taking immunosuppressive medications within 3 months prior to the enrollment in the study.
Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Taking vitamin D, antioxidant and/or anti-inflammatory supplements, taking immunosuppressive medications within 3 months prior to the enrollment in the study.
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معیار ورود به مطالعه: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن مکمل های ویتامین دی، آنتی اکسیدانت و/یا ضد التهابی، گرفتن داروهای سرکوبگر ایمنی در طی 3 ماه قبل مداخله.
معیار ورود به مطالعه: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: گرفتن مکمل های ویتامین دی، آنتی اکسیدانت و/یا ضد التهابی، گرفتن داروهای سرکوبگر ایمنی در طی 3 ماه قبل مداخله.
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Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
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گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته، به صورت خوراکی برای 12 هفته.گروه مداخله: مکمل ویتامین D (زهراوی، تبریز، تهران)، 50000 واحد، هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته، به صورت خوراکی برای 12 هفته.گروه مداخله: مکمل ویتامین D (زهراوی، تبریز، تهران)، 50000 واحد، هر دو هفته، به صورت خوراکی برای 12 هفته.
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Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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پيامدها: گلیسمیک کنترل (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: گلیسمیک کنترل (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامد ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2016-11-20, 1395/08/30
2016-11-30, 1395/09/10
2016-11-2030 00:00:00
Patients with diabetic hemodialysis
Aged 18 to 80 years
Patients with diabetic hemodialysis Aged 18 to 80 years
بیماران مبتلا به همودیالیز دیابتیک
در محدوده سنی 18 تا 80 سال
بیماران مبتلا به همودیالیز دیابتیک در محدوده سنی 18 تا 80 سال
Taking vitamin D,antioxidant and/or anti-inflammatory supplements
Taking immunosuppressive medications within 3 months prior to the enrollment in the study
Taking vitamin D,antioxidant and/or anti-inflammatory supplements Taking immunosuppressive medications within 3 months prior to the enrollment in the study
گرفتن مکمل های ویتامین دی، آنتی اکسیدانت و/یا ضد التهابی
گرفتن داروهای سرکوبگر ایمنی در طی 3 ماه قبل مداخله
گرفتن مکمل های ویتامین دی، آنتی اکسیدانت و/یا ضد التهابی گرفتن داروهای سرکوبگر ایمنی در طی 3 ماه قبل مداخله
Random assignment will be done by the use of computer-generated random numbers.
Random assignment will be done by the use of computer-generated random numbers.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه، بعد از تصادفی سازی بلوکی بالانس شده، افراد برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه، بعد از تصادفی سازی بلوکی بالانس شده، افراد برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول 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.
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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Secondary outcomes
#1
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Creatinine
Creatinine
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کراتی نین
کراتی نین
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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BUN
BUN
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BUN
BUN
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#3
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Albumin
Albumin
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آلبومین
آلبومین
empty
At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
empty
کیت آنزیمی
کیت آنزیمی
#4
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TIBC
TIBC
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TIBC
TIBC
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
Intervention groups
#1
Intervention group: Vitamin D supplements, 50000 IU, every 2 weeks, for 12 weeks orally.
Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
گروه مداخله: مکمل ویتامین D، 50000 واحد، هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه مداخله: مکمل ویتامین D (زهراوی، تبریز، تهران)، 50000 واحد، هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه مداخله: مکمل ویتامین D (زهراوی، تبریز، تهران)، 50000 واحد، هر دو هفته، به صورت خوراکی برای 12 هفته.
#2
Control group: Placebo, every 2 weeks, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.
گروه کنترل: پلاسبو، هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته، به صورت خوراکی برای 12 هفته.
گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته، به صورت خوراکی برای 12 هفته.
Recruitment centers
#1
Name of recruitment center - English: Akhavan Clinic
Name of recruitment center - Persian: کلینیک اخوان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Akhavan Clinic
Name of recruitment center - Persian: کلینیک اخوان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Akhavan Clinic Name of recruitment center - Persian: کلینیک اخوان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Semnan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی سمنان
Full name of responsible person - English: Ali Rashidipour
Full name of responsible person - Persian: علی رشیدی پور
Street address - English: Basij Blvd, Semnan
Street address - Persian: سمنان، بلوار بسیج
City - English: Semnan
City - Persian: سمنان
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, Semnan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی سمنان
Full name of responsible person - English: Ali Rashidipour
Full name of responsible person - Persian: علی رشیدی پور
Street address - English: Basij Blvd, Semnan
Street address - Persian: سمنان، بلوار بسیج
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: Rashidipour-a@sums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Semnan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی سمنان Full name of responsible person - English: Ali Rashidipour Full name of responsible person - Persian: علی رشیدی پور Street address - English: Basij Blvd, Semnan Street address - Persian: سمنان، بلوار بسیج City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: Rashidipour-a@sums.ac.ir Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
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Full name of responsible person - English:
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Latest degree:
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contact.provinces_available:
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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: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: 00
Fax:
Email: 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: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 34 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: 00 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 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: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: 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: 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: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: 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: 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: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
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هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles in patients with diabetic hemodialysis.
Design
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive vitamin D supplement (n=30) or placebo (n=30).
Settings and conduct
Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Taking vitamin D, antioxidant and/or anti-inflammatory supplements, taking immunosuppressive medications within 3 months prior to the enrollment in the study.
Intervention groups
Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
Main outcome variables
Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201611155623N92
Registration date:2016-12-21, 1395/10/01
Registration timing:retrospective
Last update:2019-09-22, 1398/06/31
Update count:1
Registration date
2016-12-21, 1395/10/01
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, Semnan University of Medical Sciences
Expected recruitment start date
2016-11-09, 1395/08/19
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of vitamin D supplementation compared with the placebo on metabolic profiles in patients with diabetic hemodialysis
Public title
Effect of supplementation in treatment of patients with diabetic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic hemodialysis
Aged 18 to 80 years
Exclusion criteria:
Taking vitamin D,antioxidant and/or anti-inflammatory supplements
Taking immunosuppressive medications within 3 months prior to the enrollment in the study
Age
From 18 years old to 80 years old
Gender
Both
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, after balanced blocked randomisation, subjects will be allocated into two groups to receive supplement or placebo. 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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
8115187159
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
IR.SEMUMS.REC.1395.144
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
2
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
9
Description
Creatinine
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
BUN
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
Albumin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
TIBC
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: Vitamin D supplements (Zahravi, Tabriz, Iran), 50000 IU, every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidipour
Street address
Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Rashidipour-a@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan 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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
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
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
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
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_r@yahoo.com
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