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Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's

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History
# Registration date Revision Id
2 2019-09-14, 1398/06/23 103566
1 2016-04-07, 1395/01/19 6103
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with Parkinson's. 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 Parkinson's and aged 50 to 90 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 Parkinson's of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Metabolic profiles will be measured at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بعلاوه ویتامین E بر پروفایل های متابولیک در بیماران مبتلا به پارکینسون 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 پارکینسون در محدوده سنی 50 تا 90 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 پارکینسون واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله:30=n) و 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: 12 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of omega-3 supplementation on disease severity and metabolic profiles in patients with Parkinson's.
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    هدف این مطالعه تعیین اثرات مکمل یاری امگا-3 بعلاوه ویتامین E بر شدت بیماری و پروفایل های متابولیک در بیماران مبتلا به پارکینسون است.
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    Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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    تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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    patients with Parkinson's of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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    شصت بیمار مبتلا به پارکینسون واجد شرایط و ارجاع شده به کلینیک شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد
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    Patients with Parkinson's and aged 50 to 80 years will be included in this study. Exclusion criteria are patients who were already taking omega-3 and/or vitamin E, had depression and had severe psychosis.
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    بیماران مبتلا به پارکینسون در سنین 50 تا 80 سال وارد مطالعه خواهند شد. معیارهای خروج از مطالعه بیمارانی هستند که قبلاً امگا 3 یا ویتامین E مصرف می کردند ، افسردگی داشتند و سایکوز شدید داشتند.
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    Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) and placebo (control group: n=30).
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    بیماران برای دریافت مکمل امگا-3 بعلاوه ویتامین E (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Fasting blood glucose, insulin resistance, insulin, inflammatory factors, oxidative stress and disease severity
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    قند خون ناشتا، مقاومت به انسولین، انسولین، فاکتورهای التهابی، استرس اکسیداتیو و شدت بیماری

  • General information

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    2016-02-20, 1394/12/01
    2016-03-10, 1394/12/20
    2016-04-08, 1395/01/20
    2016-04-10, 1395/01/22
    Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on metabolic profiles in patients with Parkinson's
    Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
    کارآزمایی بالینی اثر مکمل یاری امگا-3 بعلاوه ویتامین E در مقایسه با پلاسبو بر پروفایل های متابولیک در بیماران مبتلا به پارکینسون
    کارآزمایی بالینی اثر مکمل یاری امگا-3 بعلاوه ویتامین E در مقایسه با پلاسبو بر شدت بیماری و پروفایل های متابولیک در بیماران مبتلا به پارکینسون
    Patients with Parkinson's
    Aged 50 to 80 years
    بیماران مبتلا به پارکینسون
    سنین 50 تا 80 سال
    Patients who were already taking omega-3 and/or vitamin E
    Patients who had depression
    Patients who had severe psychosis.
    بیمارانی که قبلاً امگا 3 و / یا ویتامین E مصرف می کردند
    بیمارانی که افسردگی داشتند
    بیمارانی که سایکوز شدید داشتند
    Random assignment will be done by the use of computer-generated random numbers.
    تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    At study baseline and after balanced block randomization, subjects will be randomly divided into two groups to take either omega-3 plus vitamin E supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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    در ابتدای مطالعه و بعد از تصادفی سازی بلوکی بالانس شده، افراد به طور تصادفی به دو گروه برای دریافت مکمل یاری امگا-3 بعلاوه ویتامین E (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.
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    Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the 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.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک 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.
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  • Primary outcomes

    #1
    Total antioxidant capacity
    High-sensitivity C-reactive protein
    ظرفتیت آنتی اکسیدانی توتال
    ﭘﺮوﺗﺌﻴﻦ واﻛﻨﺸﻲ C ﺑﺎ ﺣﺴﺎﺳﻴﺖ ﺑﺎﻻ
    Spectrophotometry
    Elisa kit
    اسپکتروفتومتری
    کیت الایزا
    #2
    Malondialdehyde
    Unified Parkinson's Disease Rating Stage (UPDRS)
    مالون دی آلدئید
    مقیاس یکپارچه درجه بندی بیماری پارکینسون
    Spectrophotometry
    Physical Examination by Neurologist
    اسپکتروفتومتری
    معاینه فیزیکی توسط متخصص مغز و اعصاب

  • Secondary outcomes

    #1
    hs-CRP
    Fasting plasma glucose
    پروتئین واکنشگر C با حساسیت بالا
    گلوکز پلاسمایی ناشتا
    Elisa kit
    Enzymatic kit
    کیت الایزا
    کیت آنزیمی
    #2
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    LDL-cholesterol
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    LDL- کلسترول
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    At the beginning of the study and after 12 weeks of intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Enzymatic kit
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    کیت آنزیمی
    #3
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    Insulin resistance
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    مقاومت به انسولین
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    At the beginning of the study and after 12 weeks of intervention
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    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Calculation using HOMA formula
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    محاسبه با استفاده از فرمول HOMA

  • Intervention groups

    #1
    Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1800 mg omega-3 fatty acid plus 200 IU vitamin E, daily for 12 weeks orally.
    Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1000 mg omega-3 fatty acid plus 400 IU vitamin E, daily for 12 weeks orally.
    گروه مداخله: کپسول اسید چرب امگا-3 بعلاوه ویتامین E، 1800 میلی اسید چرب امگا-3 بعلاوه 200 واحد ویتامین E، روزانه به صورت خوراکی برای 12 هفته.
    گروه مداخله: کپسول اسید چرب امگا-3 بعلاوه ویتامین E، 1000 میلی اسید چرب امگا-3 بعلاوه 400 واحد ویتامین E، روزانه به صورت خوراکی برای 12 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک نقوی
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Street address - English: Shahid Rajaee Avenue, Kashan
    Street address - Persian: کاشان، خیابان شهید رجایی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Shahid Beheshti Clinic
    Name of recruitment center - Persian: کلینیک شهید بهشتی
    Full name of responsible person - English: Reza Daneshvar
    Full name of responsible person - Persian: رضا دانشور
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0026
    Fax:
    Email: redaneshvar@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Gholamali Hamidi
    Full name of responsible person - Persian: غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 2999
    Fax:
    Email: research@kaums.ac.ir
    Web page address:
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    Public
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    Domestic
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    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: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5562 0608
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_r@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • 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: 81151-87159
    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
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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 effects of omega-3 supplementation on disease severity and metabolic profiles in patients with Parkinson's.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
patients with Parkinson's of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with Parkinson's and aged 50 to 80 years will be included in this study. Exclusion criteria are patients who were already taking omega-3 and/or vitamin E, had depression and had severe psychosis.
Intervention groups
Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Fasting blood glucose, insulin resistance, insulin, inflammatory factors, oxidative stress and disease severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201604035623N73
Registration date: 2016-04-07, 1395/01/19
Registration timing: registered_while_recruiting

Last update: 2019-09-15, 1398/06/24
Update count: 1
Registration date
2016-04-07, 1395/01/19
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
2016-03-10, 1394/12/20
Expected recruitment end date
2016-04-10, 1395/01/22
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
Public title
Effect of supplementation in treatment of patients with Parkinson's
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Parkinson's Aged 50 to 80 years
Exclusion criteria:
Patients who were already taking omega-3 and/or vitamin E Patients who had depression Patients who had severe psychosis.
Age
From 50 years old to 80 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 balanced block randomization, subjects will be randomly divided into two groups to take either omega-3 plus vitamin E supplementation (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
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.Kaums.REC.1394.141

Health conditions studied

1

Description of health condition studied
Parkinson's disease
ICD-10 code
G31
ICD-10 code description
Other degenerative diseases of nervous system, not elsewhere classified

Primary outcomes

1

Description
High-sensitivity C-reactive protein
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

2

Description
Unified Parkinson's Disease Rating Stage (UPDRS)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Physical Examination by Neurologist

Secondary outcomes

1

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

2

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

5

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

6

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

7

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

Intervention groups

1

Description
Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1000 mg omega-3 fatty acid plus 400 IU vitamin E, daily for 12 weeks orally.
Category
Treatment - Drugs

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Clinic
Full name of responsible person
Reza Daneshvar
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0026
Email
redaneshvar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

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