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Protocol summary
Objective: The aim of this study is to determine the effects of vitamin D supplementation on cognitive functions in maintenance methadone treatment patients. 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 of maintenance methadone treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate , current depression, mania and psychosis, and history of head trauma will be excluded in the study. Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi 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 (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size. vitamin D serum, Continuum Performance task, Iowa Gambling task, Weschler logic memory, FAS test, Trial Making Task and Digit Symbol were evaluated at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: cognitive functions (primary outcomes), and depression, anxiety and stress (secondary outcome) 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 vitamin D supplementation on cognitive functions in maintenance methadone treatment patients. 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 of maintenance methadone treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate , current depression, mania and psychosis, and history of head trauma will be excluded in the study. Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi 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 (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size. vitamin D serum, Continuum Performance task, Iowa Gambling task, Weschler logic memory, FAS test, Trial Making Task and Digit Symbol were evaluated at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: cognitive functions (primary outcomes), and depression, anxiety and stress (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عملکردهای شناختی بیماران تحت درمان نگهدارنده با متادون 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 تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری و وجود دوره اخیر افسردگی، مانیا، و سایکوز از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 70 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ویتامین D (35=n) یا پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند. سطح ویتامین دی سرمی، آ آزمون عملکرد مداوم، حافظه منطقی وکسلر، تآزمون قمار آیووا و آزمون های نماد ارقام و ایجاد نقش در ابتدا و بلافاصله در انتهای مداخله از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: توجه، حافظه، تصمیم گیری ریسکی و سرعت پردازش اطلاعات (پیامد های اولیه) و افسردگی، اضطراب و استرس (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عملکردهای شناختی بیماران تحت درمان نگهدارنده با متادون 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 تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری و وجود دوره اخیر افسردگی، مانیا، و سایکوز از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 70 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ویتامین D (35=n) یا پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند. سطح ویتامین دی سرمی، آ آزمون عملکرد مداوم، حافظه منطقی وکسلر، تآزمون قمار آیووا و آزمون های نماد ارقام و ایجاد نقش در ابتدا و بلافاصله در انتهای مداخله از بیماران گرفته خواهد شد. زمان مداخله: 24 هفته. پيامدها: توجه، حافظه، تصمیم گیری ریسکی و سرعت پردازش اطلاعات (پیامد های اولیه) و افسردگی، اضطراب و استرس (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 vitamin D supplementation on cognitive functions in methadone maintenance treatment patients.
The aim of this study is to determine the effects of vitamin D supplementation on cognitive functions in methadone maintenance treatment patients.
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هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عملکردهای شناختی بیماران تحت درمان نگهدارنده با متادون است.
هدف این مطالعه تعیین اثرات مکمل یاری ویتامین D بر عملکردهای شناختی بیماران تحت درمان نگهدارنده با متادون است.
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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.
طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی.
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Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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حجم نمونه و جمعیت مورد مطالعه: 70 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی کاشان در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 70 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی کاشان در مطالعه انتخاب خواهند شد.
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Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Not living in Kashan, Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Not living in Kashan, Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
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معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: ساکن کاشان نبودن، مصرف مکمل های ویتامین D، مینرال-مولتی ویتامین و آنتی اکسیدان در طول 3 ماه گذشته قبل از شروع مداخله.
معیار ورود به مطالعه: بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18تا 60 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: ساکن کاشان نبودن، مصرف مکمل های ویتامین D، مینرال-مولتی ویتامین و آنتی اکسیدان در طول 3 ماه گذشته قبل از شروع مداخله.
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Patients will be assigned to receive either vitamin D (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size.
Patients will be assigned to receive either vitamin D (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size.
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بیماران برای دریافت یا مکمل ویتامین D (35=n) یا پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند.
بیماران برای دریافت یا مکمل ویتامین D (35=n) یا پلاسبو (35=n) تقسیم خواهند شد. کپسول های مکمل ویتامین D و پلاسبو از نظر شکل و اندازه مشابه هستند.
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Cognitive functions (primary outcome), depression and anxiety (secondary outcome) will be quantified at study baseline and end-of-trial.
Cognitive functions (primary outcome), depression and anxiety (secondary outcome) will be quantified at study baseline and end-of-trial.
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عملکردهای شناختی (پیامد اولیه)، افسردگی و اضطراب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
عملکردهای شناختی (پیامد اولیه)، افسردگی و اضطراب (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2017-05-22, 1396/03/01
2017-04-04, 1396/01/15
2017-0504-2204 00:00:00
2017-06-22, 1396/04/01
2017-05-05, 1396/02/15
2017-0605-2205 00:00:00
Patients that receiving methadone maintenance treatment
Aged 18 to 60 years
Patients that receiving methadone maintenance treatment Aged 18 to 60 years
بیماران تحت درمان نگهدارنده با متادون
در محدوده سنی 18 تا 60 سال
بیماران تحت درمان نگهدارنده با متادون در محدوده سنی 18 تا 60 سال
Not living in Kashan
Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
Not living in Kashan Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
ساکن کاشان نبودن
مصرف مکمل های ویتامین D، مینرال-مولتی ویتامین و آنتی اکسیدان در طول 3 ماه گذشته قبل از شروع مداخله
ساکن کاشان نبودن مصرف مکمل های ویتامین D، مینرال-مولتی ویتامین و آنتی اکسیدان در طول 3 ماه گذشته قبل از شروع مداخله
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Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
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نحوه تصادفی سازی با روش ساده و استفاده از اعداد تصادفی ایجاد شده توسط نرم افزار کامپیوتری (نرم افزار Stat Trek) انجام خواهد شد. در اين روش كامپيوتر اعداد تصادفي انتخاب مي كند. با در نظرگرفتن اعداد براي دو گروه تصادف سازي انجام مي گيرد. مثلا اعداد زوج در گروه مداخله و اعداد فرد در گروه شاهد قرار خواهند گرفت.
نحوه تصادفی سازی با روش ساده و استفاده از اعداد تصادفی ایجاد شده توسط نرم افزار کامپیوتری (نرم افزار Stat Trek) انجام خواهد شد. در اين روش كامپيوتر اعداد تصادفي انتخاب مي كند. با در نظرگرفتن اعداد براي دو گروه تصادف سازي انجام مي گيرد. مثلا اعداد زوج در گروه مداخله و اعداد فرد در گروه شاهد قرار خواهند گرفت.
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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.
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.
از پلاسبو برای کور سازی استفاده شده است. محققان و بیماران کور تا زمان آنالیز نهایی توسط یک کارمند آموزش دیده خواهند شد.
Depression, Anxiety, and Stress Scale-21 (DASS-21)
Beck Depression Inventory (BDI)
Beck Depression, Anxiety, and Stress Scale-21 Inventory (DASS-21BDI)
مقیاس افسردگی، اضطراب و استرس-21 (DASS-21)
پرسشنامه افسردگی بک
مقیاسپرسشنامه افسردگی، اضطراب و استرس-21 (DASS-21) بک
#2
Depression, Anxiety, and Stress Scale-21 (DASS-21)
Beck Anxiety Inventory (BAI)
Depression,Beck Anxiety, and Stress Scale-21 Inventory (DASS-21BAI)
مقیاس افسردگی، اضطراب و استرس-21 (DASS-21)
پرسشنامه اضطراب بک
مقیاس افسردگی،پرسشنامه اضطراب و استرس-21 (DASS-21)بک
#3
Stress
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Stress
استرس
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استرس
At the baseline and after intervention (24 weeks)
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At the baseline and after intervention (24 weeks)
در ابتدای مطالعه و بعد از مداخله (24 هفته)
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در ابتدای مطالعه و بعد از مداخله (24 هفته)
Depression, Anxiety, and Stress Scale-21 (DASS-21)
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Depression, Anxiety, and Stress Scale-21 (DASS-21)
مقیاس افسردگی، اضطراب و استرس-21 (DASS-21)
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مقیاس افسردگی، اضطراب و استرس-21 (DASS-21)
Recruitment centers
#1
Name of recruitment center - English: Golabchi Clinic
Name of recruitment center - Persian: کلینیک گلابچی
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Street address - English: Shahid Rajaee Avenue
Street address - Persian: 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: Golabchi Clinic
Name of recruitment center - Persian: کلینیک گلابچی
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Street address - English: Shahid Rajaee Avenue
Street address - Persian: خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8814187159
Phone: +98 31 5546 3378
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
Name of recruitment center - English: Golabchi Clinic Name of recruitment center - Persian: کلینیک گلابچی Full name of responsible person - English: Morad Rasouli-Azad Full name of responsible person - Persian: مراد رسولی آزاد Street address - English: Shahid Rajaee Avenue Street address - Persian: خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5546 3378 Fax: Email: mrasoliazad@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
Street address - Persian: 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: 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
Street address - Persian: 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: hamiidi@yahoo.com
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 Street address - Persian: 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: hamiidi@yahoo.com Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ravand 5km Road، Medical science collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
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 5554 0021
Mobile: 00
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ravand 5km Road، Medical science collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8814187159
Phone: +98 31 5554 0021
Mobile: +98 935 539 2455
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Morad Rasouli-Azad Full name of responsible person - Persian: مراد رسولی آزاد Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 048 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ravand 5km Road، Medical science collection Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5554 0021 Mobile: 00+98 935 539 2455 Fax: Email: mrasoliazad@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant professor
Position - Persian: استادیار روانشناسی بالینی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Rvand 5Km road, Kashan Medical Science Collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
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 5554 0021
Mobile: 00
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant professor
Position - Persian: استادیار روانشناسی بالینی
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Rvand 5Km road, Kashan Medical Science Collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8814187159
Phone: +98 31 5554 0021
Mobile: +98 935 539 2455
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Morad Rasouli-Azad Full name of responsible person - Persian: مراد رسولی آزاد Position - English: Assistant professor Position - Persian: استادیار روانشناسی بالینی Latest degree: phd Area of specialty/work: 048 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Rvand 5Km road, Kashan Medical Science Collection Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5554 0021 Mobile: 00+98 935 539 2455 Fax: Email: mrasoliazad@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant professor
Position - Persian: استادیار روانشناسی بالینی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Rvand 5Km road, Kashan Medical Science Collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
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 5554 0021
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morad Rasouli-Azad
Full name of responsible person - Persian: مراد رسولی آزاد
Position - English: Assistant professor
Position - Persian: استادیار روانشناسی بالینی
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Rvand 5Km road, Kashan Medical Science Collection
Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8814187159
Phone: +98 31 5554 0021
Mobile: +98 935 539 2455
Fax:
Email: mrasoliazad@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Morad Rasouli-Azad Full name of responsible person - Persian: مراد رسولی آزاد Position - English: Assistant professor Position - Persian: استادیار روانشناسی بالینی Latest degree: phd Area of specialty/work: 048 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Rvand 5Km road, Kashan Medical Science Collection Street address - Persian: کیلومتر 5 جاده راوند، مجموعه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5554 0021 Mobile: 00+98 935 539 2455 Fax: Email: mrasoliazad@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 vitamin D supplementation on cognitive functions in methadone maintenance treatment patients.
Design
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Settings and conduct
Population and sample size: 70 patients with maintenance methadone treatment of eligible and referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Not living in Kashan, Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
Intervention groups
Patients will be assigned to receive either vitamin D (n=35) or placebo (n=35). Vitamin D and placebos capsules are similar in shape and size.
Main outcome variables
Cognitive functions (primary outcome), depression and anxiety (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017101133079N4
Registration date:2017-10-12, 1396/07/20
Registration timing:retrospective
Last update:2019-09-17, 1398/06/26
Update count:1
Registration date
2017-10-12, 1396/07/20
Registrant information
Name
Morad Rasouli-Azad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 989355392455
Email address
rasouliazad-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment
Public title
The effect of Vitamin D Supplementation on Cognitive Functions in Patients Receiving Maintenance Methadone Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that receiving methadone maintenance treatment
Aged 18 to 60 years
Exclusion criteria:
Not living in Kashan
Taking vitamin D, multivitamin-mineral, and antioxidant supplements during the last 3 months before the intervention.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
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
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand 5km Road، Medical science collection
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.KAUMS.REC.1395.166
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Risky Decision Making
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Iowa Gambling Task (IGT)
2
Description
Memory
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Wechsler Logic Memory
3
Description
Verba Fluency
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
FAS task
4
Description
Speed Processing
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Digit Symbol and Trial Making Test (TMT)
Secondary outcomes
1
Description
Depression
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Beck Depression Inventory (BDI)
2
Description
Anxiety
Timepoint
At the baseline and after intervention (24 weeks)
Method of measurement
Beck Anxiety Inventory (BAI)
Intervention groups
1
Description
Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), once every 2 weeks, for 24 weeks orally
Category
Treatment - Drugs
2
Description
Intervention and control group: Methadone Maintenance Therapy (MMT)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golabchi Clinic
Full name of responsible person
Morad Rasouli-Azad
Street address
Shahid Rajaee Avenue
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5546 3378
Email
mrasoliazad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
hamiidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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 Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ravand 5km Road، Medical science collection
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Morad Rasouli-Azad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 0021
Fax
Email
mrasoliazad@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