Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor, vascular endothelial growth factor, advanced glycation end products, metalloproteinas 9 and caspase 3 in patients with diabetic retinopathy
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
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF) and vascular endothelial growth factor(VEGF) in diabetic retinopathy patients. Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion and exclusion criteria. The participants will be assigned into control and treatment groups using permuted-blocks randomization. Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet for 3 month one to two hours after lunch. For determination of zinc supplementation on serum levels of BDNF and VEGF these factors will measure by conventional lab method at baseline and endpoint of the study in both the groups. Finally, to manage effects of any confounder variables, anthropometric indices, physical activity level and psychological stress status will be measured and a 24-hour recall will be kept simultaneously with the measurements.
empty
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF) and vascular endothelial growth factor(VEGF) in diabetic retinopathy patients. Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion and exclusion criteria. The participants will be assigned into control and treatment groups using permuted-blocks randomization. Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet for 3 month one to two hours after lunch. For determination of zinc supplementation on serum levels of BDNF and VEGF these factors will measure by conventional lab method at baseline and endpoint of the study in both the groups. Finally, to manage effects of any confounder variables, anthropometric indices, physical activity level and psychological stress status will be measured and a 24-hour recall will be kept simultaneously with the measurements.
هدف از این کارآزمایی بالینی تصادفی شده با دارونما، بررسی اثر مکمل روی بر روی سطوح سرمي عامل نوروتروفيك مشتق از مغز و عامل رشد اندوتلیال عروقی در مبتلایان به رتینوپاتی دیابتی میباشد. 50 بیمار مبتلا به رتینوپاتی دیابتی که بیماری آنها از لحاظ پاتولوژیکی تایید شده است با در نظر گرفتن معیارهای ورود و خروج وارد مطالعهی حاضر خواهند شد. افرادی که وارد مطالعه شدند با روش بلوکهای تصادفی به دوگروه مورد و شاهد تقسیم خواهند شد. گروه مورد قرص 30 میلی گرمی گلوکونات روی و گروه شاهد قرصهای حاوی 30 میلی گرم مالتوز دکسترین را دریافت خواهند کرد. دریافت مکمل و پلاسبو به صورت 1 عدد در روز يك تا دو ساعت پس از صرف نهار خواهد بود. دریافت مکمل و پلاسبو به مدت 3 ماه ادامه پیدا خواهد کرد. برای تعیین اثر مکمل روی بر روی عامل نوروتروفيك مشتق از مغز و عامل رشد اندوتلیال عروقی این دو فاکتور با روشهای مرسوم آزمایشگاهی قبل و بعد از مداخله در هر دو گروه اندازه گیری خواهند شد. در نهایت، برای کنترل اثر هر گونه متغیر مداخله گر، شاخصهای تن سنجی، سطح فعالیت بدنی و وضعیت استرس روانی اندازه گیری خواهد شد و ياد آمد 24 ساعته غذايي همزمان با اندازه گیری ها به عمل خواهد آمد.
empty
هدف از این کارآزمایی بالینی تصادفی شده با دارونما، بررسی اثر مکمل روی بر روی سطوح سرمي عامل نوروتروفيك مشتق از مغز و عامل رشد اندوتلیال عروقی در مبتلایان به رتینوپاتی دیابتی میباشد. 50 بیمار مبتلا به رتینوپاتی دیابتی که بیماری آنها از لحاظ پاتولوژیکی تایید شده است با در نظر گرفتن معیارهای ورود و خروج وارد مطالعهی حاضر خواهند شد. افرادی که وارد مطالعه شدند با روش بلوکهای تصادفی به دوگروه مورد و شاهد تقسیم خواهند شد. گروه مورد قرص 30 میلی گرمی گلوکونات روی و گروه شاهد قرصهای حاوی 30 میلی گرم مالتوز دکسترین را دریافت خواهند کرد. دریافت مکمل و پلاسبو به صورت 1 عدد در روز يك تا دو ساعت پس از صرف نهار خواهد بود. دریافت مکمل و پلاسبو به مدت 3 ماه ادامه پیدا خواهد کرد. برای تعیین اثر مکمل روی بر روی عامل نوروتروفيك مشتق از مغز و عامل رشد اندوتلیال عروقی این دو فاکتور با روشهای مرسوم آزمایشگاهی قبل و بعد از مداخله در هر دو گروه اندازه گیری خواهند شد. در نهایت، برای کنترل اثر هر گونه متغیر مداخله گر، شاخصهای تن سنجی، سطح فعالیت بدنی و وضعیت استرس روانی اندازه گیری خواهد شد و ياد آمد 24 ساعته غذايي همزمان با اندازه گیری ها به عمل خواهد آمد.
empty
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF), vascular endothelial growth factor(VEGF), advanced glycation end products, Matrix Metalloproteinas 9 and caspase 3 in diabetic retinopathy patients.
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF), vascular endothelial growth factor(VEGF), advanced glycation end products, Matrix Metalloproteinas 9 and caspase 3 in diabetic retinopathy patients.
empty
هدف از این کارآزمایی بالینی تصادفی شده با دارونما، بررسی اثر مکمل روی بر روی سطوح سرمي عامل نوروتروفيك مشتق از مغز، عامل رشد اندوتلیال عروقی، محصولات نهایی گلیکاسیون پیشرفته ، متالوپروتئیناز9 و کاسپاز3 در مبتلایان به رتینوپاتی دیابتی می باشد.
هدف از این کارآزمایی بالینی تصادفی شده با دارونما، بررسی اثر مکمل روی بر روی سطوح سرمي عامل نوروتروفيك مشتق از مغز، عامل رشد اندوتلیال عروقی، محصولات نهایی گلیکاسیون پیشرفته ، متالوپروتئیناز9 و کاسپاز3 در مبتلایان به رتینوپاتی دیابتی می باشد.
empty
randomised trial with control group, parallel group, two side blinded
randomised trial with control group, parallel group, two side blinded
empty
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده
empty
The participants will be assigned into control and treatment groups using permuted-blocks randomization. This reception would be for 3 months one to two hours after lunch.
The participants will be assigned into control and treatment groups using permuted-blocks randomization. This reception would be for 3 months one to two hours after lunch.
empty
افرادی که وارد مطالعه شدند با روش بلوکهای تصادفی به دوگروه مورد و شاهد تقسیم خواهند شد. دریافت مکمل و پلاسبو به صورت 1 عدد در روز يك تا دو ساعت پس از صرف نهار خواهد بود. دریافت مکمل و پلاسبو به مدت 3 ماه ادامه پیدا خواهد کرد.
افرادی که وارد مطالعه شدند با روش بلوکهای تصادفی به دوگروه مورد و شاهد تقسیم خواهند شد. دریافت مکمل و پلاسبو به صورت 1 عدد در روز يك تا دو ساعت پس از صرف نهار خواهد بود. دریافت مکمل و پلاسبو به مدت 3 ماه ادامه پیدا خواهد کرد.
empty
Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion ( like Subject diagnosed with diabetic retinopathy) and exclusion ( like Insulin injection; Having chronic diseases such as cardiovascular disorders) criteria.
Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion ( like Subject diagnosed with diabetic retinopathy) and exclusion ( like Insulin injection; Having chronic diseases such as cardiovascular disorders) criteria.
empty
50 بیمار مبتلا به رتینوپاتی دیابتی که بیماری آنها از لحاظ پاتولوژیکی تایید شده است با در نظر گرفتن معیارهای ورود ( مثل ابتلا به بيماري رتينوپاتي ديابتي بر اساس معيارهاي ETDRS و DRS ) و خروج ( مثل دريافت انسولين و ابتلا به بيماريهاي مزمن مانند اختلالات قلبي عروقي، کليوي و کبدي ) وارد مطالعه ی حاضر خواهند شد.
50 بیمار مبتلا به رتینوپاتی دیابتی که بیماری آنها از لحاظ پاتولوژیکی تایید شده است با در نظر گرفتن معیارهای ورود ( مثل ابتلا به بيماري رتينوپاتي ديابتي بر اساس معيارهاي ETDRS و DRS ) و خروج ( مثل دريافت انسولين و ابتلا به بيماريهاي مزمن مانند اختلالات قلبي عروقي، کليوي و کبدي ) وارد مطالعه ی حاضر خواهند شد.
empty
Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet.
Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet.
empty
گروه مورد قرص 30 میلی گرمی گلوکونات روی و گروه شاهد قرصهای حاوی 30 میلی گرم مالتوز دکسترین را دریافت خواهند کرد.
گروه مورد قرص 30 میلی گرمی گلوکونات روی و گروه شاهد قرصهای حاوی 30 میلی گرم مالتوز دکسترین را دریافت خواهند کرد.
غلظت سرمی روی، عامل نوروتروفیک مشتق از مغز، عامل رشد اندوتلیال عروقی، متیل گلی اگزال، پنتوزیدین، کربوکسی متیل لیزین، متالوپروتئیناز 9، کاسپاز 3
غلظت سرمی روی، عامل نوروتروفیک مشتق از مغز، عامل رشد اندوتلیال عروقی، متیل گلی اگزال، پنتوزیدین، کربوکسی متیل لیزین، متالوپروتئیناز 9، کاسپاز 3
General information
1
1
1
1
Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor and vascular endothelial growth factor in patients with diabetic retinopathy
Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor, vascular endothelial growth factor, advanced glycation end products, metalloproteinas 9 and caspase 3 in patients with diabetic retinopathy
Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor and, vascular endothelial growth factor, advanced glycation end products, metalloproteinas 9 and caspase 3 in patients with diabetic retinopathy
کارآزمايی بالینی کنترل شده با دارونما برای تعیین اثرات مصرف خوراکی مکمل روی بر سطوح سرمی عامل نوروتروفیک مشتق از مغز و عامل رشد اندوتلیال عروقی در بیماران مبتلا به رتینوپاتی دیابتی
کارآزمايی بالینی کنترل شده با دارونما برای تعیین اثرات مصرف خوراکی مکمل روی بر سطوح سرمی عامل نوروتروفیک مشتق از مغز، عامل رشد اندوتلیال عروقی، محصولات نهایی گلیکاسیون پیشرفته، متالوپروتئیناز9 و کاسپاز3 در بیماران مبتلا به رتینوپاتی دیابتی
کارآزمايی بالینی کنترل شده با دارونما برای تعیین اثرات مصرف خوراکی مکمل روی بر سطوح سرمی عامل نوروتروفیک مشتق از مغز و، عامل رشد اندوتلیال عروقی، محصولات نهایی گلیکاسیون پیشرفته، متالوپروتئیناز9 و کاسپاز3 در بیماران مبتلا به رتینوپاتی دیابتی
Age range 40-70 years old
suffering from type 2 diabetes without insulin
Subject diagnosed with diabetic retinopathy
Age range 40-70 years old suffering from type 2 diabetes without insulin Subject diagnosed with diabetic retinopathy
دامنه سنی 70-40سال
ابتلا به بیماری دیابت نوع 2 بدون دریافت انسولین
ابتلا به بیماری رتینوپاتی دیابتی
دامنه سنی 70-40سال ابتلا به بیماری دیابت نوع 2 بدون دریافت انسولین ابتلا به بیماری رتینوپاتی دیابتی
Insulin injection
Having chronic diseases such as cardiovascular disorders, renal and hepatic
Having malabsorption syndrome and inflammatory bowel disease.
Pregnancy and lactation
Drugs interfering with zinc (Penicillin amine, Diethylenetriamine pentaacetate)
; Inhibitor drugs vascular endothelial growth factor (Avastin)
Receiving nutritional supplements from 2 months before the study (zinc, calcium, vitamin A and iron)
Exercise on a regular basis
Having a mental illness such as depression
Infectious diseases and AIDS
Alcoholism
Insulin injection Having chronic diseases such as cardiovascular disorders, renal and hepatic Having malabsorption syndrome and inflammatory bowel disease. Pregnancy and lactation Drugs interfering with zinc (Penicillin amine, Diethylenetriamine pentaacetate) ; Inhibitor drugs vascular endothelial growth factor (Avastin) Receiving nutritional supplements from 2 months before the study (zinc, calcium, vitamin A and iron) Exercise on a regular basis Having a mental illness such as depression Infectious diseases and AIDS Alcoholism
دریافت انسولین
ابتلا به بیماریهای مزمن مانند اختلالات قلبی عروقی، کلیوی و کبدی
سندرم سوء جذب و بیماریهای التهابی روده
بارداری و شیردهی
مصرف داروهای مداخله کننده با سطح سرمی روی( پنی سیلین آمین، دی اتیلن اتریامین پنتا استات)
مصرف داروهای مهار کننده عامل رشد اندوتلیال عروقی ( از قبیل Avastin)
مصرف مکملهای تغذیه ای حتی الامکان از 2 ماه قبل از مطالعه( روی، کلسیم، ویتامین A و آهن )
انجام فعالیت ورزشی به صورت منظم
داشتن بیماری روحی روانی مانند افسردگی
ابتلا به بیماریهای عفونی و ایدز
الکلیسم
دریافت انسولین ابتلا به بیماریهای مزمن مانند اختلالات قلبی عروقی، کلیوی و کبدی سندرم سوء جذب و بیماریهای التهابی روده بارداری و شیردهی مصرف داروهای مداخله کننده با سطح سرمی روی( پنی سیلین آمین، دی اتیلن اتریامین پنتا استات) مصرف داروهای مهار کننده عامل رشد اندوتلیال عروقی ( از قبیل Avastin) مصرف مکملهای تغذیه ای حتی الامکان از 2 ماه قبل از مطالعه( روی، کلسیم، ویتامین A و آهن ) انجام فعالیت ورزشی به صورت منظم داشتن بیماری روحی روانی مانند افسردگی ابتلا به بیماریهای عفونی و ایدز الکلیسم
empty
Using random block method (blocks with a volume of at least 4 to prevent the blinding of the study), using RAS software
Using random block method (blocks with a volume of at least 4 to prevent the blinding of the study), using RAS software
empty
با روش بلوک تصادفي (بلوکهايي با حجم حداقل 4 براي جلوگيري از آشکار شدن کورسازي مطالعه ) و با استفاده از نرم افزار RAS
با روش بلوک تصادفي (بلوکهايي با حجم حداقل 4 براي جلوگيري از آشکار شدن کورسازي مطالعه ) و با استفاده از نرم افزار RAS
empty
The participants and the main researcher are blinded and using randomly blocked with a minimum volume of 4 to prevent the blindness of the study.
The participants and the main researcher are blinded and using randomly blocked with a minimum volume of 4 to prevent the blindness of the study.
empty
شرکت کننده گان و محقق اصلی جزو گروه کور شدگان هستند و با روش بلوک تصادفي با حجم حداقل 4 براي جلوگيري از آشکار شدن کورسازي مطالعه صورت می گیرد.
شرکت کننده گان و محقق اصلی جزو گروه کور شدگان هستند و با روش بلوک تصادفي با حجم حداقل 4 براي جلوگيري از آشکار شدن کورسازي مطالعه صورت می گیرد.
Primary outcomes
#1
empty
serum concentration of Methylglyoxal
serum concentration of Methylglyoxal
empty
غلطت سرمی متیل گلی اگزال
غلطت سرمی متیل گلی اگزال
empty
At baseline and after 3 months of intervention
At baseline and after 3 months of intervention
empty
قبل و بعد از 3 ماه مداخله
قبل و بعد از 3 ماه مداخله
empty
ELISA
ELISA
empty
الایزا
الایزا
#2
empty
serum concentration Pentosidine
serum concentration Pentosidine
empty
غلظت سرمی پنتوزیدین
غلظت سرمی پنتوزیدین
empty
At baseline and after 3 months of intervention
At baseline and after 3 months of intervention
empty
قبل و بعد از 3 ماه مداخله
قبل و بعد از 3 ماه مداخله
empty
ELISA
ELISA
empty
الایزا
الایزا
#3
empty
serum concentration Carboxymethyl lysine
serum concentration Carboxymethyl lysine
empty
غلظت سرمی کربوکسی متیل لیزین
غلظت سرمی کربوکسی متیل لیزین
empty
At baseline and after 3 months of intervention
At baseline and after 3 months of intervention
empty
قبل و بعد از 3 ماه مداخله
قبل و بعد از 3 ماه مداخله
empty
ELISA
ELISA
empty
الایزا
الایزا
#4
empty
serum concentration Metalloproteinase 9
serum concentration Metalloproteinase 9
empty
غلظت سرمی متالوپروتئیناز 9
غلظت سرمی متالوپروتئیناز 9
empty
At baseline and after 3 months of intervention
At baseline and after 3 months of intervention
empty
قبل و بعد از 3 ماه مداخله
قبل و بعد از 3 ماه مداخله
empty
ELISA
ELISA
empty
الایزا
الایزا
#5
empty
serum concentration Caspase 3
serum concentration Caspase 3
empty
غلظت سرمی کاسپاز 3
غلظت سرمی کاسپاز 3
empty
At baseline and after 3 months of intervention
At baseline and after 3 months of intervention
empty
قبل و بعد از 3 ماه مداخله
قبل و بعد از 3 ماه مداخله
empty
ELISA
ELISA
empty
الایزا
الایزا
Recruitment centers
#1
Name of recruitment center - English: Alavi Hospital
Name of recruitment center - Persian: بیمارستان علوی
Full name of responsible person - English: Dr Habib Ojaghi
Full name of responsible person - Persian: دکتر حبیب اجاقی
Street address - English: Maadi Street , Ardebili Avenue
Street address - Persian: خیابان آیت الله مقدس اردبیلی ، خیابان شهید معادی
City - English: Ardabil
City - Persian: اردبیل
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Alavi Hospital
Name of recruitment center - Persian: بیمارستان علوی
Full name of responsible person - English: Dr Habib Ojaghi
Full name of responsible person - Persian: دکتر حبیب اجاقی
Street address - English: Maadi Street , Ardebili Avenue
Street address - Persian: خیابان آیت الله مقدس اردبیلی ، خیابان شهید معادی
City - English: Ardabil
City - Persian: اردبیل
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone:
Fax:
Email: rahmatnosraty@gmail.com
Web page address:
Name of recruitment center - English: Alavi Hospital Name of recruitment center - Persian: بیمارستان علوی Full name of responsible person - English: Dr Habib Ojaghi Full name of responsible person - Persian: دکتر حبیب اجاقی Street address - English: Maadi Street , Ardebili Avenue Street address - Persian: خیابان آیت الله مقدس اردبیلی ، خیابان شهید معادی City - English: Ardabil City - Persian: اردبیل Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: - Phone: Fax: Email: rahmatnosraty@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for Research, Tabriz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشكي تبريز
Full name of responsible person - English: Dr. Mohammad Reza Rashidi
Full name of responsible person - Persian: دکتر محمد رضا رشيدي
Street address - English: Golbad Street
Street address - Persian: خیابان گلباد
City - English: Tabriz
City - Persian: تبریز
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for Research, Tabriz University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشكي تبريز
Full name of responsible person - English: Dr. Mohammad Reza Rashidi
Full name of responsible person - Persian: دکتر محمد رضا رشيدي
Street address - English: Golbad Street
Street address - Persian: خیابان گلباد
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 41 1335 7580
Fax:
Email: rahmatnosraty@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for Research, Tabriz University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشي دانشگاه علوم پزشكي تبريز Full name of responsible person - English: Dr. Mohammad Reza Rashidi Full name of responsible person - Persian: دکتر محمد رضا رشيدي Street address - English: Golbad Street Street address - Persian: خیابان گلباد City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: - Phone: +98 41 1335 7580 Fax: Email: rahmatnosraty@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Sorayya Kheirouri
Full name of responsible person - Persian: دکتر ثریا خیروری
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 1335 7580
Mobile: 00
Fax: +98 41 1334 0634
Email: kheirouris@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Sorayya Kheirouri
Full name of responsible person - Persian: دکتر ثریا خیروری
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 1335 7580
Mobile: 00
Fax: +98 41 1334 0634
Email: kheirouris@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Sorayya Kheirouri Full name of responsible person - Persian: دکتر ثریا خیروری Position - English: Assistant professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Attar Neishabouri Street , Golgasht Avenue Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 1335 7580 Mobile: 00 Fax: +98 41 1334 0634 Email: kheirouris@tbzmed.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Sorayya Kheirouri
Full name of responsible person - Persian: دکتر ثریا خیروری
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 1335 7580
Mobile: 00
Fax: +98 41 1334 0634
Email: kheirouris@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Dr. Sorayya Kheirouri
Full name of responsible person - Persian: دکتر ثریا خیروری
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 41 1335 7580
Mobile: 00
Fax: +98 41 1334 0634
Email: kheirouris@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Dr. Sorayya Kheirouri Full name of responsible person - Persian: دکتر ثریا خیروری Position - English: Assistant professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Attar Neishabouri Street , Golgasht Avenue Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 41 1335 7580 Mobile: 00 Fax: +98 41 1334 0634 Email: kheirouris@tbzmed.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Siamack Naghizadeh
Full name of responsible person - Persian: سیامک نقی زاده
Position - English: MSc student in health sciences in nutrition
Position - Persian: دانشجوی ارشد علوم بهداشتی در تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 45 1661 8685
Mobile: +98 914 153 0197
Fax: +98 41 1334 0634
Email: siamg22@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tabriz University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
Full name of responsible person - English: Siamack Naghizadeh
Full name of responsible person - Persian: سیامک نقی زاده
Position - English: MSc student in health sciences in nutrition
Position - Persian: دانشجوی ارشد علوم بهداشتی در تغذیه
Latest degree: bachelor
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Attar Neishabouri Street , Golgasht Avenue
Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 45 1661 8685
Mobile: +98 914 153 0197
Fax: +98 41 1334 0634
Email: siamg22@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tabriz University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز Full name of responsible person - English: Siamack Naghizadeh Full name of responsible person - Persian: سیامک نقی زاده Position - English: MSc student in health sciences in nutrition Position - Persian: دانشجوی ارشد علوم بهداشتی در تغذیه Latest degree: bachelor Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Attar Neishabouri Street , Golgasht Avenue Street address - Persian: خیابان گلگشت، خیابان عطار نیشاپوری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 45 1661 8685 Mobile: +98 914 153 0197 Fax: +98 41 1334 0634 Email: siamg22@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
na
na
undecided
undecided
na
na
na
na
na
na
empty
-
-
empty
-
-
Protocol summary
Study aim
The aim of this randomized, placebo-controlled trial is to investigate the effects of zinc supplementation on serum levels of brain derived neurotrophic factor(BDNF), vascular endothelial growth factor(VEGF), advanced glycation end products, Matrix Metalloproteinas 9 and caspase 3 in diabetic retinopathy patients.
Design
randomised trial with control group, parallel group, two side blinded
Settings and conduct
The participants will be assigned into control and treatment groups using permuted-blocks randomization. This reception would be for 3 months one to two hours after lunch.
Participants/Inclusion and exclusion criteria
Fifty diabetic retinopathy patients that their disease was confirmed by pathologic assessment will include in this study according inclusion ( like Subject diagnosed with diabetic retinopathy) and exclusion ( like Insulin injection; Having chronic diseases such as cardiovascular disorders) criteria.
Intervention groups
Treatment group will receive a 30mg zinc gloconate tablet and control group will receive a 30mg maltose-dextrin tablet.
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Placebo-controlled clinical trial to determine the effects of dietary zinc supplementation on serum levels of brain-derived neurotrophic factor, vascular endothelial growth factor, advanced glycation end products, metalloproteinas 9 and caspase 3 in patients with diabetic retinopathy
Public title
Effect of zinc supplementation in the treatment of diabetic retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40-70 years old
suffering from type 2 diabetes without insulin
Subject diagnosed with diabetic retinopathy
Exclusion criteria:
Insulin injection
Having chronic diseases such as cardiovascular disorders, renal and hepatic
Having malabsorption syndrome and inflammatory bowel disease.
Pregnancy and lactation
Drugs interfering with zinc (Penicillin amine, Diethylenetriamine pentaacetate)
; Inhibitor drugs vascular endothelial growth factor (Avastin)
Receiving nutritional supplements from 2 months before the study (zinc, calcium, vitamin A and iron)
Exercise on a regular basis
Having a mental illness such as depression
Infectious diseases and AIDS
Alcoholism
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random block method (blocks with a volume of at least 4 to prevent the blinding of the study), using RAS software
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the main researcher are blinded and using randomly blocked with a minimum volume of 4 to prevent the blindness of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Approval date
2014-07-17, 1393/04/26
Ethics committee reference number
9359
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
serum concentration of zinc
Timepoint
At baseline and after 3 months of intervention
Method of measurement
atomic absorption spectrophotometry
2
Description
serum concentration of brain derived neurotrophic factor
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
3
Description
serum concentration of vascular endothelial growth factor
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
4
Description
serum concentration of Methylglyoxal
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
5
Description
serum concentration Pentosidine
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
6
Description
serum concentration Carboxymethyl lysine
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
7
Description
serum concentration Metalloproteinase 9
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
8
Description
serum concentration Caspase 3
Timepoint
At baseline and after 3 months of intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
serum concentration of Insulin
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Chemiluminescence
2
Description
Fasting blood sugar
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Enzymatic colorimetric method
3
Description
serum concentration of HbA1c
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Turbidimetry
4
Description
Insulin Resistance Index
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Based on the formula of Insulin Resistance Index
5
Description
Systolic blood pressure
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Stethoscope and sphygmomanometer
6
Description
Diastolic blood pressure
Timepoint
At baseline and after 8 weeks of intervention
Method of measurement
Stethoscope and sphygmomanometer
Intervention groups
1
Description
The case group will receive a 30mg zinc gloconate tablet for 3 months, one to two hours after lunch. The tablets will provided by jalinous pharmaceutical company in Tehran . All the patients will receive the supplements on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
Category
Treatment - Drugs
2
Description
The control group will receive a 30mg maltose- dextrin tablet as placebo for 3 months, one to two hours after lunch. The tablets will be provided by the Faculty of Pharmacy, Tabriz University of Medical Sciences.All the patients will receive the placebo on a weekly base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Dr Habib Ojaghi
Street address
Maadi Street , Ardebili Avenue
City
Ardabil
Province
East Azarbaijan
Postal code
-
Phone
Email
rahmatnosraty@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golbad Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 1335 7580
Email
rahmatnosraty@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sorayya Kheirouri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishabouri Street , Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
+98 41 1334 0634
Email
kheirouris@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sorayya Kheirouri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishabouri Street , Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7580
Fax
+98 41 1334 0634
Email
kheirouris@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Siamack Naghizadeh
Position
MSc student in health sciences in nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Attar Neishabouri Street , Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 45 1661 8685
Fax
+98 41 1334 0634
Email
siamg22@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