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Effects of vitamin D supplementation compared with the placebo 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 2019-09-15, 1398/06/24 103855
1 2015-11-04, 1394/08/13 6084
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot. 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 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: Unwillingness to cooperate will be excluded in the 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 vitamin D 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. 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 ویتامین D بر پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به زخم پای دیابتیک 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 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. 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 بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل ویتامین D (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. 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.
    empty
    empty
    The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot.
    empty
    : هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر پروفایل های متابولیک، فاکتور التهابی و بیومارکرهای استرس اکسیداتیو در بیماران مبتلا به زخم پای دیابتیک است.
    empty
    Parallel double-blind (both patients and researchers) randomized controlled clinical trial
    empty
    کارآزمایی بالینی تصادفي دو سوکور (هم بیماران و هم محققان) موازی
    empty
    Sixty 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.
    empty
    شصت 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.
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    Patients with diabetic foot according to Wagner criteria aged 40 to 85 years will be included in this study.
    empty
    بیماران مبتلا به زخم پای دیابتی بر اساس معیار واگنر در سنین 40-تا 85 سال وارد مطالعه خواهند شد.
    empty
    Patients will be assigned to receive either vitamin D supplements (intervention group: n=30) or placebo (control group: n=30).
    empty
    بیماران برای دریافت مکمل ویتامین D (گروه مداخله:30=n) یا پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
    empty
    Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
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    لوکز پلاسمایی ناشتا، پروفایل های لیپیدی، فاکتورهای التهابی، استرس اکسیداتیو و میانگین مساحت زخم

  • General information

    35
    40
    75
    85
    1
    1
    1
    Patients with diabetic foot ulcer
    Aged 40 to 85 years
    بیماران مبتلا به زخم پای دیابتی
    سنین 40 تا 85 سال
    Diabetic foot ulcer with grade 3
    Pregnant and breastfeeding patients
    Participants who consumed vitamin D supplements during the past 3 months
    Anticipated changes in medications throughout the study
    Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
    زخم پای دیابتی با گرید 3
    بیماران باردار و شیرده
    شرکت کننده هایی که در طی 3 ماه مکمل های ویتامین D مصرف کرده اند
    تغییرات پیش بینی شده در داروها در طول مطالعه
    بیماران با سابقه بیماری هایی از جمله ترومای مزمن که بر پیشرفت زخم پای دیابتی تأثیر می گذارد
    empty
    At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
    empty
    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ویتامین دی (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
    empty
    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti 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.
    empty
    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شهید بهشتی 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.
    empty
    empty

  • Primary outcomes

    #1
    Insulin
    Insulin resistance
    انسولین
    مقاومت به انسولین
    Elisa kit
    Calculation using HOMA formula
    کیت الایزا
    محاسبه با استفاده از فرمول HOMA
    #2
    Insulin resistance
    Healing of diabetic foot ulcer
    مقاومت به انسولین
    بهبود زخم پای دیابتی
    Questionnaire
    Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
    پرسشنامه
    کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
    #3
    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
    توتال آنتی اکسیدانت
    توتال آنتی اکسیدان
    #2
    empty
    Insulin
    empty
    انسولین
    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
    #3
    empty
    Vitamin D
    empty
    ویتامین D
    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
    #4
    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
    #5
    empty
    LDL-cholesterol
    empty
    LDL-کلسترول
    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
    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

  • Intervention groups

    #1
    Intervention group: Vitamin D capsule, 50000 IU, every week for 12 weeks orally.
    Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks for 12 weeks orally.
    گروه مداخله: کپسول ویتامین D، 50000 واحد، هر هفته به صورت خوراکی برای 12 هفته.
    گروه مداخله: کپسول ویتامین D، 50000 واحد، هر دو هفته 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: 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 recruitment center - English: Beheshti Clinic
    Name of recruitment center - Persian: کلینیک بهشتی
    Full name of responsible person - English: Reza Razzaghi
    Full name of responsible person - Persian: رضا رزاقی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5554 0026
    Fax:
    Email: beheshti@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: Kashan University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی کاشان
    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: Kashan University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5554 2999
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Vice chancellor for research, Kashan University of Medical Sciences
    Kashan University of Medical Sciences
    معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    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: address Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    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: PhD of Nutrition
    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: 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: 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: 8115187159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    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
The aim of this study is to determine the effects of vitamin D 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
Sixty 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.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot according to Wagner criteria aged 40 to 85 years will be included in this study.
Intervention groups
Patients will be assigned to receive either vitamin D supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201510315623N54
Registration date: 2015-11-04, 1394/08/13
Registration timing: registered_while_recruiting

Last update: 2019-09-16, 1398/06/25
Update count: 1
Registration date
2015-11-04, 1394/08/13
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
Kashan University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of vitamin D supplementation compared with the placebo 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 ulcer Aged 40 to 85 years
Exclusion criteria:
Diabetic foot ulcer with grade 3 Pregnant and breastfeeding patients Participants who consumed vitamin D supplements during the past 3 months Anticipated changes in medications throughout the study 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: 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 vitamin D 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 Shahid Beheshti 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

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.Kaums.REC.1394.92

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
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
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

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

3

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

4

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

5

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

6

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

7

Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

8

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

9

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

10

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

11

Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit

12

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

13

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

Intervention groups

1

Description
Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks for 12 weeks orally.
Category
Treatment - Drugs

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Reza Razzaghi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
beheshti@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
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
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
address Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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
8115187159
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
8115187159
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
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