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Effects of vitamin D supplementation on insulin resistance and inflammatory factor in patients with depression

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History
# Registration date Revision Id
2 2019-09-16, 1398/06/25 104724
1 2014-12-19, 1393/09/28 6059
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  • Protocol summary

    Objective: The aim of this study is to determine the effect of vitamin D supplementation on severity depression and metabolic status among patients with major depressive disorder. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 20 to 50 years, the least score 12 on BDI-II scoring system. Exclusion Criteria: Pregnancy, alcohol and drug abuse within 6 months prior to the start of the project, psychosis, mental retardation, depression caused by physical illness or drugs and substances, any type of severe, chronic physical illness, chronic physical illness and any extreme and severe mental disorders (suicidal ideation, psychotic symptoms, symptoms of manic phase, etc) will be excluded. Population and sample size: 40 patients with major depressive disorder of eligible and referred to Kargarnejad Hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the vitamin D supplements (intervention group: n=20) or placebo (control group: n=20). Fasting blood samples will be taken at baseline and after 8-wk intervention. Intervention: 8 weeks (November 1, 2014-December 31, 2014). Outcomes: Fasting plasma glucose, serum insulin, hs-CRP, insulin resistance, lipid profiles (total cholesterol, HDL-cholesterol and triglycerides) will be measured at the beginning and end of the intervention.
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    هدف این مطالعه تعیین اثر كمكي ویتامین D بر شدت افسردگی و وضعیت متابولیک در بیماران مبتلا به اختلال افسردگی اساسی است. طراحي انجام مطالعه:کارآزمایی بالینی تصادفي دوسوكور. معیارهای ورود به مطالعه: بیماران مبتلا به اختلال افسردگی اساسی بر اساس کرایتریای DSM-IV-TR، در محدوده سنی50-20سال و امتیاز حداقل 12در سیستم امتیاز دهی BDI -II وارد مطالعه خواهند شد. معیارهای خروج از مطالعه: بارداری، مصرف الکل و سوء مصرف مواد طی 6 ماه قبل از شروع طرح، علائم سایکوز، عقب ماندگی ذهنی، افسردگی ناشی از بیماری های جسمی یا مصرف داروها و مواد، هر نوع بیماری های جسمی شدید و مزمن، ابتلا به بیماری طبی حاد و شدید و بروز هرگونه اختلال شدید روانی (افکارخودکشی، علائم سایکوتیک، علائم فاز مانیا و...) از مطالعه حذف خواهند شد. حجم نمونه و جمعیت مورد مطالعه:40 بیمار مبتلا به اختلال افسردگی اساسی واجد شرایط و ارجاع شده به بیمارستان کارگرنژاد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهندشد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ویتامین D (گروه مداخله: 20=n) یا پلاسبو (گروه کنترل: 20=n) تقسیم خواهندشد. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته (از 10 آبان 1393 تا 10 دی 1393). پيامدها: گلوکز پلاسمایی ناشتا، سطوح سرمی انسولین، hs-CRP، مقاومت به انسولين، پروفایل های لیپیدی (توتال کلسترول،کلسترول HDL و تری گلیسرید) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effect of vitamin D supplementation on severity depression and metabolic status among patients with major depressive disorder.
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    هدف این مطالعه تعیین اثر كمكي ویتامین D بر شدت افسردگی و وضعیت متابولیک در بیماران مبتلا به اختلال افسردگی اساسی است.
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    Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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    طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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    Population and sample size: 40 patients with major depressive disorder of eligible and referred to Kargarnejad Hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
    empty
    حجم نمونه و جمعیت مورد مطالعه:40 بیمار مبتلا به اختلال افسردگی اساسی واجد شرایط و ارجاع شده به بیمارستان کارگرنژاد وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهندشد.
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    Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 18 to 65 years, the least score 15 on Hamilton Depression scoring system. Exclusion criteria: History of coronary infarction, angina pectoris, stroke or renal stone disease Pregnant or lactating women Smokers Liver problems Substance abuse Non-normal creatinine concentrations Taking dietary supplements during the last 2 months.
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    معیارهای ورود به مطالعه: بیماران مبتلا به اختلال افسردگی اساسی بر اساس کرایتریای DSM-IV-TR، در محدوده سنی 18-65 سال و امتیاز حداقل 15 در سیستم امتیاز دهی افسردگی هامیلتون وارد مطالعه خواهند شد. معیار خروج از مطالعه: سابقه انفارکتوس کرونر ، آنژین صدری ، بیماری سکته مغزی یا سنگ کلیه زنان باردار و شیرده افراد سیگاری مشکلات کبدی سوء مصرف مواد غلظت کراتینین غیر طبیعی مصرف مکمل های غذایی در طول 2 ماه گذشته.
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    Intervention: Patients will be assigned to receive either the vitamin D supplements (intervention group: n=20) or placebo (control group: n=20).
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    مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ویتامین D (گروه مداخله: 20=n) یا پلاسبو (گروه کنترل: 20=n) تقسیم خواهندشد.
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    Depression (primary outcome) and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
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    افسردگی (پیامد اولیه) و پروفایل های متابولیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    20
    18
    50
    65
    1
    1
    N/A
    3
    2014-10-23, 1393/08/01
    2014-11-01, 1393/08/10
    2014-11-01, 1393/08/10
    2014-11-04, 1393/08/13
    Patients with major depressive according to DSM-IV-TR criteria
    Aged 18 to 65 years
    The least score 15 on Hamilton Depression scoring system.
    شخیص قطعی اختلال افسردگی اساسی بر اساس کرایتریای DSM-IV-TR
    در محدوده سنی 18-65 سال
    امتیاز حداقل 15در سیستم امتیاز دهی افسردگی هامیلتون
    History of coronary infarction, angina pectoris, stroke or renal stone disease
    Pregnant or lactating women
    Smokers
    Liver problems
    Substance abuse
    Non-normal creatinine concentrations
    Taking dietary supplements during the last 2 months
    سابقه انفارکتوس کرونر ، آنژین صدری ، بیماری سکته مغزی یا سنگ کلیه
    زنان باردار و شیرده
    افراد سیگاری
    مشکلات کبدی
    سوء مصرف مواد
    غلظت کراتینین غیر طبیعی
    مصرف مکمل های غذایی در طول 2 ماه گذشته
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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 vitamin D supplements (n=20) or placebo (n=20). 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 ویتامین دی (n=20) و پلاسبو (n=20) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
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    از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران کور تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده خواهند شد.
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  • Primary outcomes

    #1
    Fasting plasma glucose
    Depression
    قند خون ناشتا
    افسردگی
    Baseline and End-of-trial
    At the beginning of the study and after 8 weeks of intervention
    ابتدا و انتهای مطالعه
    در ابتدای مطالعه و 8 هفته بعد از مداخله
    Enzymatic
    Questionnaire
    آنزیمی
    پرسشنامه
    #2
    Triglycerides
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #3
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #4
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    empty
    #5
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #6
    Insulin
    empty
    انسولین
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
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    الایزا
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  • Secondary outcomes

    #1
    empty
    Fasting plasma glucose
    empty
    قند خون ناشتا
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #2
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #3
    empty
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی توتال
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #4
    empty
    Glutathione
    empty
    گلوتاتیون
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #5
    empty
    Cholesterol
    empty
    کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Enzymatic
    empty
    آنزیمی
    #6
    empty
    Insulin
    empty
    انسولین
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا

  • Recruitment centers

    #1
    Name of recruitment center - English: Kargarnejad Hospital
    Name of recruitment center - Persian: بیمارستان کارگرنژاد
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    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: Kargarnejad Hospital
    Name of recruitment center - Persian: بیمارستان کارگرنژاد
    Full name of responsible person - English: Zahra Sepehrmanesh
    Full name of responsible person - Persian: زهرا سپهرمنش
    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: 8115187159
    Phone: +98 31 5546 3378
    Fax:
    Email: z.sepehrmanesh@gmail.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: Hamid Reza Banafshe
    Full name of responsible person - Persian: حمیدرضا بنفشه
    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: 8814187159
    Phone: +98 31 5554 2999
    Fax:
    Email: banafshe57@hotmail.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    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:

    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 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: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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: +98
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.irasemi_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: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    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
    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:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
    Street address - Persian:
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: +98
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: 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: +98
    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
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    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effect of vitamin D supplementation on severity depression and metabolic status among patients with major depressive disorder.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 40 patients with major depressive disorder of eligible and referred to Kargarnejad Hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with major depressive according to DSM-IV-TR criteria, aged 18 to 65 years, the least score 15 on Hamilton Depression scoring system. Exclusion criteria: History of coronary infarction, angina pectoris, stroke or renal stone disease Pregnant or lactating women Smokers Liver problems Substance abuse Non-normal creatinine concentrations Taking dietary supplements during the last 2 months.
Intervention groups
Intervention: Patients will be assigned to receive either the vitamin D supplements (intervention group: n=20) or placebo (control group: n=20).
Main outcome variables
Depression (primary outcome) and metabolic profiles (secondary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201412065623N29
Registration date: 2014-12-19, 1393/09/28
Registration timing: retrospective

Last update: 2019-09-23, 1398/07/01
Update count: 1
Registration date
2014-12-19, 1393/09/28
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
2014-11-01, 1393/08/10
Expected recruitment end date
2014-11-04, 1393/08/13
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 on insulin resistance and inflammatory factor in patients with depression
Public title
Effect of supplementation in treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depressive according to DSM-IV-TR criteria Aged 18 to 65 years The least score 15 on Hamilton Depression scoring system.
Exclusion criteria:
History of coronary infarction, angina pectoris, stroke or renal stone disease Pregnant or lactating women Smokers Liver problems Substance abuse Non-normal creatinine concentrations Taking dietary supplements during the last 2 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
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=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo has been used to achieve masking of participants and investigators. The researchers and patients will be concealed until the final analyses by a trained staff.
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
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
4230/1/5/29/p

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Depression
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

2

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

3

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

4

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

5

Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic

6

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa

Intervention groups

1

Description
Intervention group: Vitamin D pearl, 50000 IU, weekly, for 8 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo pearl, weekly, for 8 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
Zahra Sepehrmanesh
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
z.sepehrmanesh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
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
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
Email
asemi_z@kaums.ac.ir

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
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac
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
+98
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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