A Clinical trial to assess the effect of melatonin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
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Protocol summary
Objective: The aim of this study is to determine the effects of melatonin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance 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 on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30). Melatonin and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. The time between beginning and end of the intervention is 12 weeks. Outcomes: Biomarkers of inflammation and oxidative stress (primary outcomes), Mental health parameters and genetic response (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 melatonin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance 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 on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30). Melatonin and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. The time between beginning and end of the intervention is 12 weeks. Outcomes: Biomarkers of inflammation and oxidative stress (primary outcomes), Mental health parameters and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ملاتونین بر پارامترهای سلامت روان، پروفایل های متابولیک و پاسخ ژنتیکی در 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 از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ملاتونین (n=30) یا پلاسبو (n=30) تقسیم خواهند شد. کپسول های مکمل ملاتونین و 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: بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای اولیه)، پارامترهای سلامت روان و پاسخ ژنتیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ملاتونین بر پارامترهای سلامت روان، پروفایل های متابولیک و پاسخ ژنتیکی در 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 از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ملاتونین (n=30) یا پلاسبو (n=30) تقسیم خواهند شد. کپسول های مکمل ملاتونین و 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: بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای اولیه)، پارامترهای سلامت روان و پاسخ ژنتیکی (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 melatonin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients.
The aim of this study is to determine the effects of melatonin supplementation on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients.
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هدف این مطالعه تعیین اثرات مکمل یاری ملاتونین بر پارامترهای سلامت روان، پروفایل های متابولیک و پاسخ ژنتیکی در بیماران تحت درمان نگهدارنده با متادون است.
هدف این مطالعه تعیین اثرات مکمل یاری ملاتونین بر پارامترهای سلامت روان، پروفایل های متابولیک و پاسخ ژنتیکی در 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: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.
Population and sample size: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.
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حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران در مطالعه انتخاب خواهند شد.
حجم نمونه و جمعیت مورد مطالعه: 60 بیمار تحت درمان نگهدارنده با متادون واجد شرایط و ارجاع شده به کلینیک گلابچی وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران 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: Unwillingness to cooperate.
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
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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 از مطالعه خارج خواهند 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 از مطالعه خارج خواهند شد.
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Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30).
Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30).
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مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ملاتونین (n=30) یا پلاسبو (n=30) تقسیم خواهند شد.
مداخله مورد مطالعه: بیماران برای دریافت یا مکمل ملاتونین (n=30) یا پلاسبو (n=30) تقسیم خواهند شد.
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Total antioxidant (primary outcome), other metabolic profiles, mental health parameters and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
Total antioxidant (primary outcome), other metabolic profiles, mental health parameters and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
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توتال آنتی اکسیدانت (پیامد اولیه)، سایر پروفایل های متابولیک، پارامترهای سلامت روان و پاسخ ژنتیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
توتال آنتی اکسیدانت (پیامد اولیه)، سایر پروفایل های متابولیک، پارامترهای سلامت روان و پاسخ ژنتیکی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
Both
Male
bothmale
1
1
1
1
Patients on maintenance methadone treatment
Age of 18 to 60 years
Patients on maintenance methadone treatment Age of 18 to 60 years
بیماران تحت درمان نگهدارنده با متادون
محدوده سنی 18 تا 60 سال
بیماران تحت درمان نگهدارنده با متادون محدوده سنی 18 تا 60 سال
Unwillingness to cooperate
Unwillingness to cooperate
عدم تمایل به همکاری
عدم تمایل به همکاری
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Simple randomization
Simple randomization
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تصادفی ساده
تصادفی ساده
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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.
Primary outcomes
#1
oxidative stess
Total antioxidant
oxidative stessTotal antioxidant
اکسیداتیو استرس
توتال آنتی اکسیدانت
اکسیداتیو استرستوتال آنتی اکسیدانت
FRAP, TBARS
Spectrophotometry
FRAP, TBARSSpectrophotometry
FRAP, TBARS
اسپکتروفتومتری
FRAP, TBARSاسپکتروفتومتری
#2
Total antioxidant
empty
Total antioxidant
توتال آنتی اکسیدانت
empty
توتال آنتی اکسیدانت
At the beginning of the study and after 12 weeks of intervention
empty
At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
Spectrophotometry
empty
Spectrophotometry
اسپکتروفتومتری
empty
اسپکتروفتومتری
#3
Malondialdehyde
empty
Malondialdehyde
مالون دی آلدئید
empty
مالون دی آلدئید
At the beginning of the study and after 12 weeks of intervention
empty
At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
Spectrophotometry
empty
Spectrophotometry
اسپکتروفتومتری
empty
اسپکتروفتومتری
#4
Glutathione
empty
Glutathione
گلوتاتیون
empty
گلوتاتیون
At the beginning of the study and after 12 weeks of intervention
empty
At the beginning of the study and after 12 weeks of intervention
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
Spectrophotometry
empty
Spectrophotometry
اسپکتروفتومتری
empty
اسپکتروفتومتری
Secondary outcomes
#1
empty
Total glutathione
Total glutathione
empty
توتال گلوتاتیون
توتال گلوتاتیون
empty
At the beginning of the study and 12 weeks after intervention
At the beginning of the study and 12 weeks after intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
#2
empty
Malondialdehyde
Malondialdehyde
empty
ماون دی آلدئید
ماون دی آلدئید
empty
At the beginning of the study and 12 weeks after intervention
At the beginning of the study and 12 weeks after intervention
empty
در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
Recruitment centers
#1
Name of recruitment center - English: Gholabchi Clinic
Name of recruitment center - Persian: کلینیک گلابچی
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: Gholabchi Clinic
Name of recruitment center - Persian: کلینیک گلابچی
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: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8814187159
Phone: +98 31 5544 0022
Fax:
Email: asemi_r@yahoo.com
Web page address:
Name of recruitment center - English: Gholabchi Clinic Name of recruitment center - Persian: کلینیک گلابچی 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: Isfehan Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5544 0022 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:
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: 8814187159
Phone: +98 31 5554 2999
Fax:
Email: hamidi.gholamali2@gmail.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, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8814187159 Phone: +98 31 5554 2999 Fax: Email: hamidi.gholamali2@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
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 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:
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: 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: 8814187159
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: PhD of Nutrition Position - Persian: دکتری 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: 8814187159 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: 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:
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: 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: 8814187159
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: PhD of Nutrition Position - Persian: دکتری 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: 8814187159 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: 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:
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: 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: 8814187159
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: PhD of Nutrition Position - Persian: دکتری 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: 8814187159 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
no
no
no
no
no
no
no
no
no
no
no
no
no
no
empty
No - There is not a plan to make this available
No - There is not a plan to make this available
empty
خیر - برنامهای برای انتشار آن وجود ندارد
خیر - برنامهای برای انتشار آن وجود ندارد
Protocol summary
Study aim
The aim of this study is to determine the effects of melatonin supplementation on mental health parameters, metabolic profiles and genetic response 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: 60 eligible patients on methadone maintenance treatment referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study.
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: Unwillingness to cooperate.
Intervention groups
Intervention: Patients will be assigned to receive either melatonin (n=30) or placebo (n=30).
Main outcome variables
Total antioxidant (primary outcome), other metabolic profiles, mental health parameters and genetic response (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017072933551N3
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:2018-04-28, 1397/02/08
Update count:2
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-08-03, 1396/05/12
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effect of melatonin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients
Public title
Effect of melatonin supplementation in treatment of maintenance methadone treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients on maintenance methadone treatment
Age of 18 to 60 years
Exclusion criteria:
Unwillingness to cooperate
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.Kaums.REC.1396.50
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
6
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
Depression beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
9
Description
Anxiety beck score
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
10
Description
Expressed levels of LL-1 gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
11
Description
Expressed levels of LL-8 gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
12
Description
Expressed levels of TNF-a gene
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
13
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
PCR
14
Description
Total glutathione
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Spectrophotometry
15
Description
Malondialdehyde
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two oral capsules, one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo oral capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5544 0022
Email
asemi_r@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, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5554 2999
Email
hamidi.gholamali2@gmail.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 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
8814187159
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
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
8814187159
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
8814187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD