Effects of long-term vitamin D supplementation compared with the placebo on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
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Protocol summary
Objective: The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD). 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: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention. Fasting blood samples will be taken at baseline and after 24-wk intervention to measure metabolic profiles. Start and end date of intervention: 24 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin and lipid profiles will be measured at baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD). 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: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention. Fasting blood samples will be taken at baseline and after 24-wk intervention to measure metabolic profiles. Start and end date of intervention: 24 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin and lipid profiles will be measured at baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری طولانی مدت ویتامین D بر ضخامت اینتیما- مدیای کاروتید (CIMT) و پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است. طراحی 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 مطالعه: افراد 75-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت روزانه 50000 واحد مکمل ویتامین D (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. ضخامت اینتیما- مدیای کاروتید در ابتدا و 24 هفته بعد از مداخله تعیین خواهد شد. نمونه خون ناشتا در ابتدای مطالعه و 24 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین و پروفایل های لیپیدی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری طولانی مدت ویتامین D بر ضخامت اینتیما- مدیای کاروتید (CIMT) و پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است. طراحی 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 مطالعه: افراد 75-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت روزانه 50000 واحد مکمل ویتامین D (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. ضخامت اینتیما- مدیای کاروتید در ابتدا و 24 هفته بعد از مداخله تعیین خواهد شد. نمونه خون ناشتا در ابتدای مطالعه و 24 هفته بعد از مداخله برای تعیین پروفایل های متابولیک از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین و پروفایل های لیپیدی در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
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هدف این مطالعه تعیین اثرات مکمل یاری طولانی مدت ویتامین D بر ضخامت اینتیما- مدیای کاروتید (CIMT) و پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است.
هدف این مطالعه تعیین اثرات مکمل یاری طولانی مدت ویتامین D بر ضخامت اینتیما- مدیای کاروتید (CIMT) و پروفایل های متابولیک در بیماران دیابت تیپ 2 مبتلا به کرونر قلبی است.
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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.
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.
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طراحی 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.
طراحی 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.
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Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 فرد مبتلا به بیماری دیابت تیپ 2 با کرونر قلبی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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Inclusion criteria: Invituals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Consuming vitamin D supplements within the past 3 months, having an acute myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months, important hepatic failure and adequate vitamin D status.
Inclusion criteria: Invituals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Consuming vitamin D supplements within the past 3 months, having an acute myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months, important hepatic failure and adequate vitamin D status.
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معیار ورود مطالعه: افراد 85-40 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: مصرف مکمل ویتامین D در سه ماه گذشته، داشتن انفارکتوس حاد در 3 ماه گذشته، داشتن عمل جراحی قلب در سه ماه گذشته، اختلال کبدی بالقوه و سطح نرمال ویتامین D.
معیار ورود مطالعه: افراد 85-40 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی در این مطالعه وارد خواهند شد. معیار خروج از مطالعه: مصرف مکمل ویتامین D در سه ماه گذشته، داشتن انفارکتوس حاد در 3 ماه گذشته، داشتن عمل جراحی قلب در سه ماه گذشته، اختلال کبدی بالقوه و سطح نرمال ویتامین D.
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Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention.
Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention.
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مداخله مورد مطالعه: بیماران برای دریافت روزانه 50000 واحد مکمل ویتامین D (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. ضخامت اینتیما- مدیای کاروتید در ابتدا و 24 هفته بعد از مداخله تعیین خواهد شد.
مداخله مورد مطالعه: بیماران برای دریافت روزانه 50000 واحد مکمل ویتامین D (گروه مداخله: 30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. ضخامت اینتیما- مدیای کاروتید در ابتدا و 24 هفته بعد از مداخله تعیین خواهد شد.
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Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
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پيامدها: بیومارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی و متابولیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: بیومارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی و متابولیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2015-11-01, 1394/08/10
2015-10-29, 1394/08/07
2015-1110-0129 00:00:00
2015-11-11, 1394/08/20
2015-11-06, 1394/08/15
2015-11-1106 00:00:00
Subjects aged 40-85 years
Diagnosed with type 2 diabetes and coronary heart disease
Subjects aged 40-85 years Diagnosed with type 2 diabetes and coronary heart disease
افراد 85-40 ساله
تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی
افراد 85-40 ساله تشخیص ابتلا به بیماری دیابت تیپ 2 و کرونر قلبی
Consuming vitamin D supplements within the past 3 months
Having an acute myocardial infarction within the past 3 months
Having cardiac surgery within the past 3 months
Important hepatic failure
Adequate vitamin D status
Consuming vitamin D supplements within the past 3 months Having an acute myocardial infarction within the past 3 months Having cardiac surgery within the past 3 months Important hepatic failure Adequate vitamin D status
مصرف مکمل ویتامین D در سه ماه گذشته
داشتن انفارکتوس حاد در 3 ماه گذشته
داشتن عمل جراحی قلب در سه ماه گذشته
اختلال کبدی بالقوه
سطح نرمال ویتامین D
مصرف مکمل ویتامین D در سه ماه گذشته داشتن انفارکتوس حاد در 3 ماه گذشته داشتن عمل جراحی قلب در سه ماه گذشته اختلال کبدی بالقوه سطح نرمال ویتامین D
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take vitamin D 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 age, subjects will be randomly divided into two groups to take vitamin D 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 سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین D (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 سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین D (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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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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Primary outcomes
#1
Carotid intima media thickness
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Carotid intima media thickness
ضخامت اینتیما- مدیای کاروتید
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ضخامت اینتیما- مدیای کاروتید
At the beginning of the study and after 24 weeks of intervention
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At the beginning of the study and after 24 weeks of intervention
در ابتدای مطالعه و 24 هفته بعد از مداخله
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در ابتدای مطالعه و 24 هفته بعد از مداخله
Sonography
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Sonography
سونوگرافی
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سونوگرافی
Secondary outcomes
#1
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Hs-CRP
Hs-CRP
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پروتئین واکنشگر C با حساسیت بالا
پروتئین واکنشگر C با حساسیت بالا
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
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در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
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Elisa kit
Elisa kit
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الایزا
الایزا
#2
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Nitric oxide
Nitric oxide
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نیتریک اکساید
نیتریک اکساید
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
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در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#3
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Malondialdehyde
Malondialdehyde
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مالون دی آلدئید
مالون دی آلدئید
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
empty
در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#4
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Glutathione
Glutathione
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گلوتاتیون
گلوتاتیون
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
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در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#5
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Total antioxidant capacity
Total antioxidant capacity
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ظرفیت آنتی اکسیدانی توتال
ظرفیت آنتی اکسیدانی توتال
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
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در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
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Spectrophotometry
Spectrophotometry
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اسپکتروفتومتری
اسپکتروفتومتری
#6
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Carotid intima media thickness
Carotid intima media thickness
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ضخامت اینتیما- مدیای کاروتید
ضخامت اینتیما- مدیای کاروتید
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At the beginning of the study and after 24 weeks of intervention
At the beginning of the study and after 24 weeks of intervention
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در ابتدای مطالعه و 24 هفته بعد از مداخله
در ابتدای مطالعه و 24 هفته بعد از مداخله
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Sonography
Sonography
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سونوگرافی
سونوگرافی
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: 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: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: 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: 81151-87159
Phone: +98 31 5546 3378
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Naghavi Clinic Name of recruitment center - Persian: کلینیک نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: 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: 81151-87159 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, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
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Latest degree:
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contact.provinces_available:
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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: 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:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: دکتری تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: PhD of Nutrition Position - Persian: دکتری تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
Design
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.
Settings and conduct
Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Invituals aged 40-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Consuming vitamin D supplements within the past 3 months, having an acute myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months, important hepatic failure and adequate vitamin D status.
Intervention groups
Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention.
Main outcome variables
Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201510315623N56
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:2019-09-24, 1398/07/02
Update count:1
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-10-29, 1394/08/07
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of long-term vitamin D supplementation compared with the placebo on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 40-85 years
Diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Consuming vitamin D supplements within the past 3 months
Having an acute myocardial infarction within the past 3 months
Having cardiac surgery within the past 3 months
Important hepatic failure
Adequate vitamin D status
Age
From 40 years old to 85 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 and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take vitamin D 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
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.KAUMS.REC.1394.91
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Ischaemic heart disease (chronic) NOS
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Glutathione
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Carotid intima media thickness
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
Intervention groups
1
Description
Control group: Placebo capsule, every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
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
Email
asemi_z@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available