Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on clinical and metabolic status in patients with multiple sclerosis
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Protocol summary
Objective: The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 20-60 years diagnosed with multiple sclerosis will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30). omega-3, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes) will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 20-60 years diagnosed with multiple sclerosis will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30). omega-3, vitamin D and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر علایم بالینی و پروفایل های متابولیک در بیماران مبتلا به مالتیپل اسکلروزیس است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 60-20 ساله مبتلا به بیماری مالتیپل اسکلروزیس. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به مالتیپل اسکلروزیس ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های امگا-3 و ویتامین D با پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: علایم بالینی و فاکتورهای التهابی (پیامدهای اولیه) و مارکرهای متابولیسم انسولین، پروفایل لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر علایم بالینی و پروفایل های متابولیک در بیماران مبتلا به مالتیپل اسکلروزیس است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: افراد 60-20 ساله مبتلا به بیماری مالتیپل اسکلروزیس. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به مالتیپل اسکلروزیس ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های امگا-3 و ویتامین D با پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: علایم بالینی و فاکتورهای التهابی (پیامدهای اولیه) و مارکرهای متابولیسم انسولین، پروفایل لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis.
The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis.
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هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر علایم بالینی و پروفایل های متابولیک در بیماران مبتلا به مالتیپل اسکلروزیس است.
هدف این مطالعه تعیین اثرات مکمل یاری ترکیب امگا-3 و ویتامین D بر علایم بالینی و پروفایل های متابولیک در بیماران مبتلا به مالتیپل اسکلروزیس است.
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Parallel double-blind (both patients and researchers) clinical trial.
Parallel double-blind (both patients and researchers) clinical trial.
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کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
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از بین بیماران مبتلا به مالتیپل اسکلروزیس ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
از بین بیماران مبتلا به مالتیپل اسکلروزیس ارجاع شده به کلینیک بهشتی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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Inclusion criteria: Individuals aged 18-55 years diagnosed with multiple sclerosis will be included in this study.
Exclusion criteria: pregnancy or lactating during the past 6 mo, a history of nephrolithiasis during the previous 5 y, menopause, defined as no regular menstruation, and unwillingness to use appropriate contraception.
Inclusion criteria: Individuals aged 18-55 years diagnosed with multiple sclerosis will be included in this study. Exclusion criteria: pregnancy or lactating during the past 6 mo, a history of nephrolithiasis during the previous 5 y, menopause, defined as no regular menstruation, and unwillingness to use appropriate contraception.
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معیار ورود به مطالعه: افراد 55-18 ساله مبتلا به بیماری مالتیپل اسکلروزیس.
عیار خروج از مطالعه: حاملگی یا شیردهی در طی 6 ماه گذشته ، سابقه نفرولیتیتازیس در 5 سال گذشته، یائسگی ، بدون قاعدگی منظم و عدم تمایل به استفاده از روشهای پیشگیری از بارداری
معیار ورود به مطالعه: افراد 55-18 ساله مبتلا به بیماری مالتیپل اسکلروزیس. عیار خروج از مطالعه: حاملگی یا شیردهی در طی 6 ماه گذشته ، سابقه نفرولیتیتازیس در 5 سال گذشته، یائسگی ، بدون قاعدگی منظم و عدم تمایل به استفاده از روشهای پیشگیری از بارداری
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Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30).
Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30).
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بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
بیماران به دو گروه برای دریافت ترکیب ویتامین D و امگا-3 (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
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Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes)
Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes)
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علایم بالینی و فاکتورهای التهابی (پیامدهای اولیه) و مارکرهای متابولیسم انسولین، پروفایل لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه)
علایم بالینی و فاکتورهای التهابی (پیامدهای اولیه) و مارکرهای متابولیسم انسولین، پروفایل لیپیدی و بیومارکرهای استرس اکسیداتیو (پیامدهای ثانویه)
General information
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2018
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Patients with multiple sclerosis
Aged 18-55 years
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Patients with multiple sclerosis Aged 18-55 years Course of disease relapsing–remitting MS (RRMS) EDSS ≤4.5
بیماران مبتلا به مالتیپل اسکلروزیس
سنین 18-55 سال
دوره بیماری عودتکننده-بهبود یابنده ام اس (RRMS)
EDSS ≤4.5
بیماران مبتلا به مالتیپل اسکلروزیس سنین 18-55 سال دوره بیماری عودتکننده-بهبود یابنده ام اس (RRMS) EDSS ≤4.5
Pregnancy
Lactating during the past 6 month
History of nephrolithiasis during the previous5 y
No regular menstruation
Menopause
Unwillingnessto use appropriate contraception
Pregnancy Lactating during the past 6 month History of nephrolithiasis during the previous5 y No regular menstruation Menopause Unwillingnessto use appropriate contraception
بارداری
زنانی که در طی شش ماه گذشته شیردهی می کردند
سابقه نفرولیتیازیس در طول 5 سال گذشته
بدون قاعدگی منظم
یائسگی
عدم تمایل برای استفاده از وسایل پیشگیری از بارداری مناسب
بارداری زنانی که در طی شش ماه گذشته شیردهی می کردند سابقه نفرولیتیازیس در طول 5 سال گذشته بدون قاعدگی منظم یائسگی عدم تمایل برای استفاده از وسایل پیشگیری از بارداری مناسب
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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 combined omega-3 and vitamin D supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined omega-3 and vitamin D 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 طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل یاری ترکیب امگا-3 و ویتامین D (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.
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 یاری ترکیب امگا-3 و ویتامین D (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.
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.
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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Secondary outcomes
#1
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25-hydroxyvitamin D
25-hydroxyvitamin D
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25-هیدروکسی ویتامین D
25-هیدروکسی ویتامین D
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At the beginning of the study and after 12 weeks of intervention
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
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Elisa kit
Elisa kit
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کیت الایزا
کیت الایزا
#2
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Fasting plasma glucose
Fasting plasma glucose
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گلوکز پلاسمایی ناشتا
گلوکز پلاسمایی ناشتا
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At the beginning of the study and after 12 weeks of intervention
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
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#3
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LDL-cholesterol
LDL-cholesterol
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LDL-کلسترول
LDL-کلسترول
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At the beginning of the study and after 12 weeks of intervention
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
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
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: Ebrahim Kouchak
Full name of responsible person - Persian: ابراهیم کوچکی
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: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Beheshti Clinic Name of recruitment center - Persian: کلینیک بهشتی Full name of responsible person - English: Zatollah AsemiEbrahim Kouchak Full name of responsible person - Persian: ذات اله عاصمیابراهیم کوچکی 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: asemi_r@yahoo.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:
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: 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
public
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Domestic
domestic
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Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D 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: Ph.D 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:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 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; 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: Ph.D 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: Ph.D 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:
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: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 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; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D 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: Ph.D 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:
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: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 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; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
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
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis.
Design
Parallel double-blind (both patients and researchers) clinical trial.
Settings and conduct
Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 18-55 years diagnosed with multiple sclerosis will be included in this study.
Exclusion criteria: pregnancy or lactating during the past 6 mo, a history of nephrolithiasis during the previous 5 y, menopause, defined as no regular menstruation, and unwillingness to use appropriate contraception.
Intervention groups
Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30).
Main outcome variables
Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017090133941N20
Registration date:2017-11-16, 1396/08/25
Registration timing:retrospective
Last update:2019-09-18, 1398/06/27
Update count:1
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-20, 1396/07/28
Expected recruitment end date
2017-11-05, 1396/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on clinical and metabolic status in patients with multiple sclerosis
Public title
Effect of combined omega-3 and vitamin D supplementation in treatment of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multiple sclerosis
Aged 18-55 years
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Exclusion criteria:
Pregnancy
Lactating during the past 6 month
History of nephrolithiasis during the previous5 y
No regular menstruation
Menopause
Unwillingnessto use appropriate contraception
Age
From 18 years old to 55 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 combined omega-3 and vitamin D 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
empty
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
2017-10-19, 1396/07/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.64
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating disease of the central nervous system
Primary outcomes
1
Description
Expanded Disability Status Scale (EDSS)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Physical examination by neurologist
2
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
5
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
6
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
25-hydroxyvitamin D
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
10
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 2000 mg omega-3 daily (NutMega, Australia) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Ebrahim Kouchak
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0026
Email
asemi_r@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
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
Ph.D 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 scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D 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
Ph.D 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