Clinical trial of the effect of magnesium supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in diabetic hemodialysis patients
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients. 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: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive magnesium supplement (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size. CIMT will be determined at baseline and after 24 weeks intervention. 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.
empty
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients. 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: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive magnesium supplement (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size. CIMT will be determined at baseline and after 24 weeks intervention. 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 منیزیم بر ضخامت اینتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران همودیالیزی دیابتیک 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: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار همودیالیزی دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب مکمل یاری منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. قرص های منیزیم 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.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر ضخامت اینتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران همودیالیزی دیابتیک 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: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار همودیالیزی دیابتیک واجد شرایط و ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب مکمل یاری منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. قرص های منیزیم 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.
empty
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients.
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients.
empty
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر ضخامت اینتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران همودیالیزی دیابتیک است.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر ضخامت اینتیما-مدیای شریان کاروتید و پروفایل های متابولیک در بیماران همودیالیزی دیابتیک است.
empty
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 magnesium 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 magnesium supplement (n=30) or placebo (n=30).
empty
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 منیزیم (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 منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
empty
Among diabetic hemodialysis patients referred to Yasrebi 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 24 weeks after the intervention. At the beginning and the end of the intervention: 24 weeks.
Among diabetic hemodialysis patients referred to Yasrebi 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 24 weeks after the intervention. At the beginning and the end of the intervention: 24 weeks.
empty
از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک یثربی 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 24 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته.
از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک یثربی 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 24 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته.
empty
Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Patients with inflammatory and malignant diseases, taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, taking immunosuppressive agents
Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Patients with inflammatory and malignant diseases, taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, taking immunosuppressive agents
empty
معیار ورود به مطالعه: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: بیماران مبتلا به بیماری های بدخیم و التهابی، گرفتن مکمل منیزیم، مکمل های آنتی اکسیدانت و/یا ضد التهابی در طی 3 ماه قبل مداخله، گرفتن داروهای سرکوبگر ایمنی
معیار ورود به مطالعه: بیماران همودیالیزی دیابتیک در محدوده سنی 18 تا 80 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: بیماران مبتلا به بیماری های بدخیم و التهابی، گرفتن مکمل منیزیم، مکمل های آنتی اکسیدانت و/یا ضد التهابی در طی 3 ماه قبل مداخله، گرفتن داروهای سرکوبگر ایمنی
empty
Intervention group: Magnesium supplements (21st Century Pharmaceutical Company, Arizona, USA), 250 mg, one capsule for 24 weeks orally. Control group: placebo (Barij Essence, Kashan, Iran), one capsule for 24 weeks orally.
Intervention group: Magnesium supplements (21st Century Pharmaceutical Company, Arizona, USA), 250 mg, one capsule for 24 weeks orally. Control group: placebo (Barij Essence, Kashan, Iran), one capsule for 24 weeks orally.
empty
گروه مداخله: مکمل منیزیم (شرکت داروسازی قرن 21، آریزونا، آمریکا)، 250 میلی گرم، یک کپسول برای 24 هفته به صورت خوراکی. گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، یک کپسول برای 24 هفته به صورت خوراکی.
گروه مداخله: مکمل منیزیم (شرکت داروسازی قرن 21، آریزونا، آمریکا)، 250 میلی گرم، یک کپسول برای 24 هفته به صورت خوراکی. گروه کنترل: کپسول پلاسبو (باریج اسانس، کاشان، ایران)، یک کپسول برای 24 هفته به صورت خوراکی.
empty
Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
empty
پيامدها: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: ضخامت انتیما-مدیای شریان کاروتید (پیامد اولیه) و پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
1
1
1
1
1
1
Diabetic hemodialysis patients
Aged 18 to 80 years
Diabetic hemodialysis patients Aged 18 to 80 years
بیماران همودیالیزی دیابتیک
سن 18 تا 80 سال
بیماران همودیالیزی دیابتیک سن 18 تا 80 سال
Patients with inflammatory and malignant diseases
Taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
Taking immunosuppressive agents
Patients with inflammatory and malignant diseases Taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study Taking immunosuppressive agents
بیماران مبتلا به بیماری های بدخیم و التهابی
گرفتن مکمل منیزیم، مکمل های آنتی اکسیدانت و/یا ضد التهابی در طی 3 ماه قبل مداخله
گرفتن داروهای سرکوبگر ایمنی
بیماران مبتلا به بیماری های بدخیم و التهابی گرفتن مکمل منیزیم، مکمل های آنتی اکسیدانت و/یا ضد التهابی در طی 3 ماه قبل مداخله گرفتن داروهای سرکوبگر ایمنی
empty
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
empty
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<50 و ≥50)، افراد به طور تصادفی 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 و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<50 و ≥50)، افراد به طور تصادفی 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.
empty
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.
empty
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.
Intervention group: 250 mg magnesium (21st Century Pharmaceutical Company, Arizona, USA), daily for 24 weeks orally.
Intervention group: 250 mg magnesium (Jalinous pharmaceutical21st Century Pharmaceutical Company, TehranArizona, IranUSA), daily for 24 weeks orally.
گروه مداخله: 250 میلی گرم منیزیم (شركت داروسازی جالینوس، تهران، ایران)، روزانه برای 24 هفته به صورت خوراکی.
گروه مداخله: 250 میلی گرم منیزیم (شركت داروسازی قرن 21، آریزونا، آمریکا)، روزانه برای 24 هفته به صورت خوراکی.
گروه مداخله: 250 میلی گرم منیزیم (شركت داروسازی جالینوسقرن 21، تهرانآریزونا، ایرانآمریکا)، روزانه برای 24 هفته به صورت خوراکی.
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: Yasrebi Clinic
Name of recruitment center - Persian: کلینیک یثربی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
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 4446 0180
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: AkhavanYasrebi Clinic Name of recruitment center - Persian: کلینیک اخوانیثربی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee AvenueGhotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجاییبلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 4446 0180 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:
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 پزشكي كاشان
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 پزشكي كاشان
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 پزشكي كاشان 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:
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 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
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients.
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 magnesium supplement (n=30) or placebo (n=30).
Settings and conduct
Among diabetic hemodialysis patients referred to Yasrebi 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 24 weeks after the intervention. At the beginning and the end of the intervention: 24 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Patients with inflammatory and malignant diseases, taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, taking immunosuppressive agents
Intervention groups
Intervention group: Magnesium supplements (21st Century Pharmaceutical Company, Arizona, USA), 250 mg, one capsule for 24 weeks orally. Control group: placebo (Barij Essence, Kashan, Iran), one capsule for 24 weeks orally.
Main outcome variables
Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017090133941N19
Registration date:2017-11-20, 1396/08/29
Registration timing:retrospective
Last update:2019-09-19, 1398/06/28
Update count:2
Registration date
2017-11-20, 1396/08/29
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
2017-10-20, 1396/07/28
Expected recruitment end date
2017-11-03, 1396/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of magnesium supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in diabetic hemodialysis patients
Public title
Effect of magnesium supplementation in treatment of diabetic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic hemodialysis patients
Aged 18 to 80 years
Exclusion criteria:
Patients with inflammatory and malignant diseases
Taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
Taking immunosuppressive agents
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y), subjects will be randomly divided 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 Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.69
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
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
Triglycerides
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
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: 250 mg magnesium (21st Century Pharmaceutical Company, Arizona, USA), daily for 24 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily for 24 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasrebi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
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