Clinical trial of the effect of magnesium supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot ulcer
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Protocol summary
Objective: The aim of this study is to determine the effects of magnesium supplementation on metabolic profiles in patients with diabetic foot ulcer. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic foot ulcer of 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 magnesium (n=30) or placebo (n=30). Magnesium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondry 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 magnesium supplementation on metabolic profiles in patients with diabetic foot ulcer. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic foot ulcer of 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 magnesium (n=30) or placebo (n=30). Magnesium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی 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 یا مکمل منیزیم (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی 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 یا مکمل منیزیم (30=n) یا پلاسبو (30=n) تقسیم خواهند شد. کپسول های مکمل منیزیم و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه)، پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (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 magnesium supplementation on metabolic profiles in patients with diabetic foot ulcer.
The aim of this study is to determine the effects of magnesium supplementation on metabolic profiles in patients with diabetic foot ulcer.
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هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
هدف این مطالعه تعیین اثرات مکمل یاری منیزیم بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
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A parallel group, double-blind (both patients and researchers,) randomized controlled clinical trial.
A parallel group, double-blind (both patients and researchers,) randomized controlled clinical trial.
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور (هم بیماران و هم محققان)، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور (هم بیماران و هم محققان)، تصادفی شده
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Sixty patients with diabetic foot ulcer referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
Sixty patients with diabetic foot ulcer referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
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شصت بیمار مبتلا به زخم پای دیابتی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران انتخاب خواهند شد. تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در بیمارستان نقوی 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.
شصت بیمار مبتلا به زخم پای دیابتی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران انتخاب خواهند شد. تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در بیمارستان نقوی 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.
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Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years old. Non-inclusion criteria:
pregnant and breastfed patients; taking magnesium, multivitamin-mineral and antioxidant supplements, and anti- inflammatory agents; patients with history of diseases which influence the development of DFU including chronic
trauma; patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years old. Non-inclusion criteria: pregnant and breastfed patients; taking magnesium, multivitamin-mineral and antioxidant supplements, and anti- inflammatory agents; patients with history of diseases which influence the development of DFU including chronic trauma; patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
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معیارهای ورود: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال.معیارهای عدم ورود: بیماران باردار و شیرده؛ مصرف منیزیم ،مکمل های مولتی ویتامین معدنی و آنتی اکسیدانی و داروهای ضد التهابی؛ بیماران با سابقه بیماری هایی از جمله ترومای مزمن که بر پیشرفت زخم پای دیابتی تأثیر می گذارد
معیارهای ورود: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال.معیارهای عدم ورود: بیماران باردار و شیرده؛ مصرف منیزیم ،مکمل های مولتی ویتامین معدنی و آنتی اکسیدانی و داروهای ضد التهابی؛ بیماران با سابقه بیماری هایی از جمله ترومای مزمن که بر پیشرفت زخم پای دیابتی تأثیر می گذارد
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Intervention group: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Intervention group: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
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گروه مداخله: کپسول منیزیم، 250 میلی گرم اکسید منیزیم (قرن 21، آمریکا)، یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه مداخله: کپسول منیزیم، 250 میلی گرم اکسید منیزیم (قرن 21، آمریکا)، یک بار در روز، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، یک بار در روز، به صورت خوراکی برای 12 هفته.
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Mean ulcer area, Markers of insulin metabolism, lipid profiles, biomarkers of inflammation; oxidative stress
Mean ulcer area, Markers of insulin metabolism, lipid profiles, biomarkers of inflammation; oxidative stress
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
بخاطر یک اشتباه، درخواست برای بروزرسانی در وب سایت ما بعد از چاپ مقاله انجام شد. اگرچه، اصلاحات مطابق با یا پروپوزال تصویب شده اولیه یا با هماهنگی معاونت پژوهشی دانشگاه بود.
Clinical trial of the effect of magnesium supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer
Clinical trial of the effect of magnesium supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot ulcer
Clinical trial of the effect of magnesium supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot ulcer
کارآزمایی بالینی اثر مکمل یاری منیزیم در مقایسه با پلاسبو بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی
کارآزمایی بالینی اثر مکمل یاری منیزیم در مقایسه با پلاسبو بر بهبود زخم و پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی
کارآزمایی بالینی اثر مکمل یاری منیزیم در مقایسه با پلاسبو بر بهبود زخم و پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی
Patients with diabetic foot ulcer
Aged 40 to 85 years
Patients with diabetic foot ulcer Aged 40 to 85 years
بیماران مبتلا به زخم پای دیابتی
سنین 40 تا 85 سال
بیماران مبتلا به زخم پای دیابتی سنین 40 تا 85 سال
Pregnant and breastfed patients
Taking magnesium,multivitamin-mineral and antioxidant supplements and anti-inflammatory agents
Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Pregnant and breastfed patients Taking magnesium,multivitamin-mineral and antioxidant supplements and anti-inflammatory agents Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
بیماران باردار و شیرده
مصرف منیزیم، مولتی ویتامین-مینرال و مکمل های آنتی اکسیدانی و داروهای ضد التهابی
بیماران با سابقه بیماری هایی از جمله ترومای مزمن که بر پیشرفت زخم پای دیابتی تأثیر می گذارد
بیماران باردار و شیرده مصرف منیزیم، مولتی ویتامین-مینرال و مکمل های آنتی اکسیدانی و داروهای ضد التهابی بیماران با سابقه بیماری هایی از جمله ترومای مزمن که بر پیشرفت زخم پای دیابتی تأثیر می گذارد
Random assignment will be done by the use of computer-generated random numbers.
Random assignment will be done by the use of computer-generated random numbers.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either magnesium supplements (n = 35) or placebo (n = 35). 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 either magnesium supplements (n = 35) or placebo (n = 35). 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 منیزیم (n = 35) و پلاسبو (n = 35) 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 منیزیم (n = 35) و پلاسبو (n = 35) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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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 Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
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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 بیمارستان نقوی 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.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در بیمارستان نقوی 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.
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Primary outcomes
#1
Insulin
Insulin resistance
Insulin resistance
انسولین
مقاومت به انسولین
مقاومت به انسولین
Elisa kit
Calculation using HOMA formula
Elisa kitCalculation using HOMA formula
کیت الایزا
محاسبه با استفاده از فرمول HOMA
کیت الایزامحاسبه با استفاده از فرمول HOMA
#2
Insulin resistance
Healing of diabetic foot ulcer (Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm))
Insulin resistanceHealing of diabetic foot ulcer (Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm))
مقاومت به انسولین
بهبود زخم پای دیابتی (کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر))
مقاومتبهبود زخم پای دیابتی (کاهش اندازه زخم نسبت به انسولیناندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر))
Questionnaire
Ruler
QuestionnaireRuler
پرسشنامه
خط کش
پرسشنامهخط کش
#3
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Insulin
Insulin
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انسولین
انسولین
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Elisa kit
Elisa kit
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کیت الایزا
کیت الایزا
Secondary outcomes
#1
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LDL cholesterol
LDL cholesterol
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LDL-کلسترول
LDL-کلسترول
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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HbA1c
HbA1c
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HbA1c
HbA1c
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Biochemical kit
Biochemical kit
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کیت بیوشیمیایی
کیت بیوشیمیایی
Intervention groups
#1
Intervention group: Magnesium capsule, 220 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
Intervention group: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
Intervention group: Magnesium capsule, 220250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
گروه مداخله: کپسول منیزیم، 220 میلی گرم اکسید منیزیم (قرن 21، آمریکا)، یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه مداخله: کپسول منیزیم، 250 میلی گرم اکسید منیزیم (قرن 21، آمریکا)، یک بار در روز، به صورت خوراکی برای 12 هفته.
گروه مداخله: کپسول منیزیم، 220250 میلی گرم اکسید منیزیم (قرن 21، آمریکا)، یک بار در روز، به صورت خوراکی برای 12 هفته.
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: Reza Razzaghi
Full name of responsible person - Persian: رضا رزاقی
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 5554 0026
Fax:
Email: razzaghi_r@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi Clinic Name of recruitment center - Persian: کلینیک نقوی Full name of responsible person - English: Zatollah AsemiReza Razzaghi Full name of responsible person - Persian: ذات اله عاصمیرضا رزاقی 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 5554 0026 Fax: Email: razzaghi_r@kaums.ac.ir 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: 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:
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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:
Name of organization / entity - Persian:
Full name of responsible person - English:
Full name of responsible person - Persian:
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work:
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available:
Country:
Postal code:
Phone:
Mobile:
Fax:
Email:
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: Nutritionist
Position - Persian: متخصص 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 5562 0608
Mobile: +98 913 361 5446
Fax:
Email: asemi_r@yahoo.com
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: Nutritionist Position - Persian: متخصص 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 5562 0608 Mobile: +98 913 361 5446 Fax: Email: asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: PhD of Nutrition
Position - Persian: 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: 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: ذ ات 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:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذ ات 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: ذ ات 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:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
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هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of magnesium supplementation on metabolic profiles in patients with diabetic foot ulcer.
Design
A parallel group, double-blind (both patients and researchers,) randomized controlled clinical trial.
Settings and conduct
Sixty patients with diabetic foot ulcer referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years old. Non-inclusion criteria:
pregnant and breastfed patients; taking magnesium, multivitamin-mineral and antioxidant supplements, and anti- inflammatory agents; patients with history of diseases which influence the development of DFU including chronic
trauma; patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Intervention groups
Intervention group: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Main outcome variables
Mean ulcer area, Markers of insulin metabolism, lipid profiles, biomarkers of inflammation; oxidative stress
General information
Reason for update
Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
Acronym
IRCT registration information
IRCT registration number:IRCT201612225623N96
Registration date:2017-01-02, 1395/10/13
Registration timing:retrospective
Last update:2019-11-05, 1398/08/14
Update count:1
Registration date
2017-01-02, 1395/10/13
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
2016-10-26, 1395/08/05
Expected recruitment end date
2016-11-24, 1395/09/04
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 wound healing and metabolic profiles in patients with diabetic foot ulcer
Public title
Effect of supplementation in treatment of patients with diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcer
Aged 40 to 85 years
Exclusion criteria:
Pregnant and breastfed patients
Taking magnesium,multivitamin-mineral and antioxidant supplements and anti-inflammatory agents
Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
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 either magnesium supplements (n = 35) or placebo (n = 35). Randomization will be done by the use of computer-generated random numbers
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 Naghavi Hospital affiliated to Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will assigned the participants to the numbered bottles of capsules.
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
2016-10-25, 1395/08/04
Ethics committee reference number
IR.Kaums.REC.1395.74
Health conditions studied
1
Description of health condition studied
Diabetic foot
ICD-10 code
E14.5
ICD-10 code description
With peripheral circulatory complications
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
2
Description
Healing of diabetic foot ulcer (Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm))
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Ruler
3
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
9
Description
LDL cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit
Intervention groups
1
Description
Intervention group: Magnesium capsule, 250 mg oxide magnesium (21 century, USA), once a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Reza Razzaghi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
razzaghi_r@kaums.ac.ir
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
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
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
Nutritionist
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 5562 0608
Email
asemi_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
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