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Effects of zinc supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot

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History
# Registration date Revision Id
2 2019-09-26, 1398/07/04 107013
1 2015-07-03, 1394/04/12 6076
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of zinc supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with diabetic foot according to Wagner criteria, higher than 5 years of their disease and aged 35 to 75 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune) and pregnant or lactating women will be included in this study. Population and sample size: 60 patients with diabetic foot of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either zinc supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and End Date of Intervention: 3 months (Sebtember 7, 2015-December 7, 2015). Outcomes: Fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH) will be meseaured at study baseline and End-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روی بر پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به زخم پای دیابتیک است. طراحي انجام مطالعه: کارآزمایی بالینی تصادفي دو سوكور. معیارهای ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی بر اساس معیار واگنر، بیشتر از 5 سال از سابقه بیماری آن ها و در محدوده سنی 35 تا 75 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه: استفاده از درمان های جايگزين از قبیل هورمون يا مكمل هاي ويتاميني، افراد مبتلا به بيماري مزمن كليوي، كبدي، ريوي و بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه و آلرژی، افراد با نقص سیستم ایمنی (اتوایمیون) و زنان باردار و شیرده از مطالعه حذف خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل روی (گروه مداخله:30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 3 ماه (از 16 شهریور 1394 تا 16 آذر 1394). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، hs-CRP، ظرفیت آنتی اکسیدانی توتال و گلوتاتیون توتال پلاسما در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    Objective: The aim of this study is to determine the effects of zinc supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری روی بر پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به زخم پای دیابتیک است.
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    Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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    تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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    60 patients with diabetic foot of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
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    Inclusion Criteria: Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease aged 40 to 85 years. Exclusion Criteria: The use of substitute treatments including hormone or vitamin or zinc supplements, patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant, lactating.
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    بیماران مبتلا به زخم پای دیابتی بر اساس معیار واگنر بیشتر از 5 سال از سابقه بیماری آن ها در محدوده سنی 40 تا 85 سال. معیارهای خروج از مطالعه: استفاده از درمان های جايگزين از قبیل هورمون يا روی یا مكمل هاي ويتاميني، افراد مبتلا به بيماري مزمن كليوي، كبدي، ريوي، بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه؛ آلرژی، افراد با نقص سیستم ایمنی (اتوایمیون)، زنان باردار، شیرده.
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    Intervention: Patients will be assigned to receive either zinc supplements (intervention group: n=30) or placebo (control group: n=30).
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    مداخله مورد مطالعه: بیماران برای دریافت مکمل روی (گروه مداخله:30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Mean ulcer area and markers of insulin metabolism (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at baseline and end-of-trial.
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    میانگین مساحت زخم و مارکرهای متابولیسم انسولین (پیامدهای اولیه) و سایر پروفایل های متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مطالعه اندازه گیری خواهد شد.

  • General information

    35
    40
    75
    85
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    2015-07-06, 1394/04/15
    2015-06-02, 1394/03/12
    2015-08-06, 1394/05/15
    2015-08-01, 1394/05/10
    Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease; aged 40 to 85 years
    بیماران مبتلا به زخم پای دیابتی بر اساس معیار واگنر بیشتر از 5 سال از سابقه بیماری آن ها در محدوده سنی 40 تا 85 سال
    The use of substitute treatments including hormone or vitamin or zinc supplements
    Patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies
    Patients with low immune system ability (autoimmune)
    Pregnant
    Lactating
    استفاده از درمان های جايگزين از قبیل هورمون يا مكمل هاي ويتاميني یا روی
    افراد مبتلا به بيماري مزمن كليوي، كبدي، ريوي، بيماري های مزمن يا حاد التهابي، بیماری دریچه قلب، سندروم روده کوتاه؛ آلرژی، (اتوایمیون)
    افراد با نقص سیستم ایمنی
    زنان باردار
    شیرده
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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 zinc supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل روی (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از 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 clinic, who is not involved in the trial and not aware of random sequences, will be 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 کلینیک 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
    Baseline and End-of-trial
    At the beginning of the study and after 12 weeks of intervention
    ابتدا و انتهای مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Elisa
    Elisa kit
    الایزا
    کیت الایزا
    #2
    Fasting plasma glucose
    insulin resistance
    قند خون ناشتا
    مقاومت به انسولین
    Baseline and End-of-trial
    At the beginning of the study and after 12 weeks of intervention
    ابتدا و انتهای مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Enzymatic
    Calculation using HOMA formula
    آنزیمی
    محاسبه با استفاده از فرمول HOMA
    #3
    Hs-CRP
    Healing of diabetic foot ulcer
    پروتئین واکنشگر C با حساسیت بالا
    بهبود زخم پای دیابتی
    Baseline and End-of-trial
    At the beginning of the study and after 12 weeks of intervention
    ابتدا و انتهای مداخله
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    Elisa
    Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
    الایزا
    کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
    #4
    Nitric oxide
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    نیتریک اکساید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    Triglyceride
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #6
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #7
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #8
    Total antioxidant capacity
    empty
    ظرفتیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #9
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #10
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #11
    Added at 2016-10-17: Ulcer length, width and depth
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    بروزرسانی 1395/7/26: طول، عرض و عمق زخم.
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    Added at 2016-10-17: Baseline and 12 weeks after the intervention.
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    بروزرسانی 1395/7/26: ابتدا و 12 هفته بعد از مداخله
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    Added at 2016-10-17: Sterile probe
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    بروزرسانی 1395/7/26: میله استریل
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  • Secondary outcomes

    #1
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    Triglycerides
    empty
    تری گلیسرید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #2
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #3
    empty
    HDL-cholesterol
    empty
    کلسترول HDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    LDL-cholesterol
    empty
    کلسترول LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    VLDL-cholesterol
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    کلسترول VLDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #7
    empty
    Total antioxidant
    empty
    آنتی اکسیدانت توتال
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #8
    empty
    Hs-CRP
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #9
    empty
    Malondialdehyde
    empty
    مالون دی آلدئید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #10
    empty
    Fasting plasma glucose
    empty
    گلوکز پلاسمایی ناشتا
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #11
    empty
    HbA1c
    empty
    HbA1c
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Biochemical kit
    empty
    کیت بیوشیمیایی

  • Intervention groups

    #1
    Intervention group: Zinc capsule, 40 mg, daily for 12 weeks orally.
    Intervention group: Zinc capsule, 50 mg, daily for 12 weeks orally.
    گروه مداخله: کپسول روی، 40 میلی گرم، روزانه به صورت خوراکی برای 12 هفته.
    گروه مداخله: کپسول روی، 50 میلی گرم، روزانه به صورت خوراکی برای 12 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Beheshti Clinic
    Name of recruitment center - Persian: کلینیک بهشتی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Bolvare Ghotbe Ravandi, 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 recruitment center - English: Beheshti Clinic
    Name of recruitment center - Persian: کلینیک بهشتی
    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: 81151-87159
    Phone: +98 31 5562 0608
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    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
    Street address - English: Bolvare Ghotbe Ravandi, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Bolvare Ghotbe Ravandi, 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 0022
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
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    Public
    empty
    Domestic
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    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    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:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: 00
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutrition PhD
    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: Bolvare Ghotbe Ravandi, 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: Nutrition PhD
    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_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: Nutrition PhD
    Position - Persian: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bolvare Ghotbe Ravandi, 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: Nutrition PhD
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 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_r@yahoo.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    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.

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of zinc supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Settings and conduct
60 patients with diabetic foot of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease aged 40 to 85 years. Exclusion Criteria: The use of substitute treatments including hormone or vitamin or zinc supplements, patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant, lactating.
Intervention groups
Intervention: Patients will be assigned to receive either zinc supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Mean ulcer area and markers of insulin metabolism (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201506215623N46
Registration date: 2015-07-03, 1394/04/12
Registration timing: registered_while_recruiting

Last update: 2019-10-09, 1398/07/17
Update count: 1
Registration date
2015-07-03, 1394/04/12
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
Kashan University of Medical Sciences
Expected recruitment start date
2015-06-02, 1394/03/12
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of zinc supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot
Public title
Effects of supplementation in the treatment of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease; aged 40 to 85 years
Exclusion criteria:
The use of substitute treatments including hormone or vitamin or zinc supplements Patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies Patients with low immune system ability (autoimmune) Pregnant Lactating
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either zinc supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be 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
Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
IR.Kaums.REC.1394.31

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
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

3

Description
Healing of diabetic foot ulcer
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)

Secondary outcomes

1

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

6

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
Total antioxidant
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
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

10

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

11

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: Zinc capsule, 50 mg, daily for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule, daily for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
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
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0022
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
Associate professor
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
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
Nutrition PhD
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_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
Nutrition PhD
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_r@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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