Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in type 2 diabetic patients with coronary heart disease
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Protocol summary
Objective: The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 74 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=37) or placebo (n=37). omega-3, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (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 combined omega-3 and vitamin D supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 74 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=37) or placebo (n=37). omega-3, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر ضخامت انتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 74 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (37=n) یا پلاسبو (37=n) اختصاص داده خواهند شد. کپسول های امگا-3 و ویتامین D با پلاسبو از نظر شکل و اندازه مشابه هستند. 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 از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر ضخامت انتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 74 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (37=n) یا پلاسبو (37=n) اختصاص داده خواهند شد. کپسول های امگا-3 و ویتامین D با پلاسبو از نظر شکل و اندازه مشابه هستند. 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 از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
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هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر ضخامت انتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است.
هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر ضخامت انتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران دیابتی تیپ 2 با بیماری کرونر قلبی است.
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Randomized double-blind placebo-controlled trial.
Randomized double-blind placebo-controlled trial.
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کارآزمایی بالینی دو سوکور کنترل شده با دارونما
کارآزمایی بالینی دو سوکور کنترل شده با دارونما
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Among patients with coronary heart disease referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 74 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 the beginning and the end of intervention.
Among patients with coronary heart disease referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 74 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 the beginning and the end of intervention.
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از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان، 74 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. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدا و پایان مداخله از بیماران گرفته خواهد شد.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان، 74 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. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدا و پایان مداخله از بیماران گرفته خواهد شد.
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Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes, CHD and vitamin D-deficient. Exclusion criteria: Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months, experiencing an acute myocardial infarction or cardiac surgery within the past 3 months, renal or hepatic disorder.
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes, CHD and vitamin D-deficient. Exclusion criteria: Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months, experiencing an acute myocardial infarction or cardiac surgery within the past 3 months, renal or hepatic disorder.
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معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2، کرونر قلبی و کمبود ویتامین D. معیار خروج از مطالعه: مصرف مکمل ویتامین D و اسیدهای چرب امگا-3 در طی سه ماه قبل، تجربه سکته قلبی حاد یا جراحی قلب در طی سه ماه گذشته، اختلال کلیوی یا کبدی.
معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2، کرونر قلبی و کمبود ویتامین D. معیار خروج از مطالعه: مصرف مکمل ویتامین D و اسیدهای چرب امگا-3 در طی سه ماه قبل، تجربه سکته قلبی حاد یا جراحی قلب در طی سه ماه گذشته، اختلال کلیوی یا کبدی.
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Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally.
Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally.
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally.
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گروه مداخله: 2000 میلی گرم امگا-3 روزانه (باریج اسانس، کاشان، ایران) و 50000 واحد ویتامین دی (زهراوی، تبریز، ایران) هر دو هفته، به صورت خوراکی برای 24 هفته
گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته به صورت خوراکی برای 24 هفته
گروه مداخله: 2000 میلی گرم امگا-3 روزانه (باریج اسانس، کاشان، ایران) و 50000 واحد ویتامین دی (زهراوی، تبریز، ایران) هر دو هفته، به صورت خوراکی برای 24 هفته گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته به صورت خوراکی برای 24 هفته
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Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will
Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will
Subjects aged 45-85 years
Diagnosed with type 2 diabetes and coronary heart disease
Vitamin D-deficient
Subjects aged 45-85 years Diagnosed with type 2 diabetes and coronary heart disease Vitamin D-deficient
افراد 85-45 ساله
مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی
مبتلا به کمبود ویتامین D
افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی مبتلا به کمبود ویتامین D
Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months
Experiencing an acute myocardial infarction or cardiac surgery within the past 3 months
Renal or hepatic disorder
Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months Experiencing an acute myocardial infarction or cardiac surgery within the past 3 months Renal or hepatic disorder
مصرف مکمل ویتامین D و اسیدهای چرب امگا- 3 در طی سه ماه گذشته
تجربه یک سکته قلبی حاد یا جراحی قلب در طی سه ماه گذشته
اختلال کلیوی یا کبدی
مصرف مکمل ویتامین D و اسیدهای چرب امگا- 3 در طی سه ماه گذشته تجربه یک سکته قلبی حاد یا جراحی قلب در طی سه ماه گذشته اختلال کلیوی یا کبدی
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 and vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 and vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx
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برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی و سن تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری ترکیب امگا-3 و ویتامین D یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار Stat Trek انجام می شود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. https://stattrek.com/statistics/random-number-generator.aspx
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی و سن تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری ترکیب امگا-3 و ویتامین D یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار Stat Trek انجام می شود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. https://stattrek.com/statistics/random-number-generator.aspx
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinics affiliated with Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinics affiliated with Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی باریج اسانس در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود.بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک قلب وابسته به دانشگاه علوم پزشکی کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد. مکمل ها و پلاسبو در شرکت داروسازی باریج اسانس در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود.بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود.
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Intervention groups
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Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 24 weeks orally.
Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally.
Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally.
گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، به صورت خوراکی برای 24 هفته.
گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته به صورت خوراکی برای 24 هفته.
گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، هر دو هفته به صورت خوراکی برای 24 هفته.
Recruitment centers
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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: 8115187159
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: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_r@yahoo.com Web page address:
Sponsors / Funding sources
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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:
Name of organization / entity - English:
Name of organization / entity - Persian:
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: 8115187159
Phone: +98 31 5554 2999
Fax:
Email: hamidi_gh@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: 8115187159 Phone: +98 31 5554 2999 Fax: Email: hamidi_gh@kaums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Person responsible for general 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: Ph.D 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:
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: Ph.D 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: 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: Ph.D 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: 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 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: Ph.D 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: Ph.D 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: 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: Ph.D 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: 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: Ph.D 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:
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: Ph.D 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: 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: Ph.D 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: 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
na
na
undecided
undecided
na
na
na
na
na
na
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 combined omega-3 and vitamin D supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Design
Randomized double-blind placebo-controlled trial.
Settings and conduct
Among patients with coronary heart disease referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 74 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 the beginning and the end of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes, CHD and vitamin D-deficient. Exclusion criteria: Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months, experiencing an acute myocardial infarction or cardiac surgery within the past 3 months, renal or hepatic disorder.
Intervention groups
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally.
Control group: Placebo capsule (Barij Essence, Kashan, Iran), every 2 weeks for 24 weeks orally.
Main outcome variables
Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017090133941N15
Registration date:2017-11-01, 1396/08/10
Registration timing:retrospective
Last update:2019-09-16, 1398/06/25
Update count:2
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-13, 1396/07/21
Expected recruitment end date
2017-10-27, 1396/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Effect of combined omega-3 and vitamin D supplementation in treatment of coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 45-85 years
Diagnosed with type 2 diabetes and coronary heart disease
Vitamin D-deficient
Exclusion criteria:
Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months
Experiencing an acute myocardial infarction or cardiac surgery within the past 3 months
Renal or hepatic disorder
Age
From 45 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 and vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinics affiliated with Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.79
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Mean left CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
2
Description
Maximum left CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
3
Description
Mean right CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
4
Description
Maximum right CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
Secondary 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
Calculation using HOMA formula
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
HDL
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Hs-CRP
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Barij Essence, Kashan, Iran), 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
8115187159
Phone
+98 31 5546 3378
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Ph.D 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 scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D 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
Ph.D 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available