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Protocol summary
Objective: Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major. Design: cross-over clinical trial. Setting and conduct: After signing a written informed consent, All participants will be randomly assigned to alpha lipoic acid and placebo each for 8 weeks. After 3 weeks washout period, the second phase will be started. Then the participants will be crossed over to the alternate group for additional 8 weeks. To assess the compliance of the participants, every two week a 3 day dietary record and a 3 day physical activity record will be taken. Anthropometric measurements and biochemical assessments will be measured at the beginning and end of each phases.Major inclusion criteria: Patient with β- Thalassemia Major.
Major exclusion criteria: Use of chelator other than Deferoxamine, antioxidant supplement and anti inflammatory drugs consumption. Intervention: Patient in the alpha lipoic acid group were asked to daily intake a 600 mg alpha lipoic acid capsule for 8 weeks. Main outcome measures: serum triglyceride (TG), total-cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein cholesterol (HDL-c ), Malondialdehyde ( MDA), Total Antioxidant Capacity (TAC), Ferritin, Serum Iron, Transferrin Iron Binding Capacity (TIBC), Complete Blood count ( CBC).
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Objective: Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major. Design: cross-over clinical trial. Setting and conduct: After signing a written informed consent, All participants will be randomly assigned to alpha lipoic acid and placebo each for 8 weeks. After 3 weeks washout period, the second phase will be started. Then the participants will be crossed over to the alternate group for additional 8 weeks. To assess the compliance of the participants, every two week a 3 day dietary record and a 3 day physical activity record will be taken. Anthropometric measurements and biochemical assessments will be measured at the beginning and end of each phases.Major inclusion criteria: Patient with β- Thalassemia Major. Major exclusion criteria: Use of chelator other than Deferoxamine, antioxidant supplement and anti inflammatory drugs consumption. Intervention: Patient in the alpha lipoic acid group were asked to daily intake a 600 mg alpha lipoic acid capsule for 8 weeks. Main outcome measures: serum triglyceride (TG), total-cholesterol (TC), low density lipoprotein (LDL-C), high density lipoprotein cholesterol (HDL-c ), Malondialdehyde ( MDA), Total Antioxidant Capacity (TAC), Ferritin, Serum Iron, Transferrin Iron Binding Capacity (TIBC), Complete Blood count ( CBC).
هدف: تعیین اثر مکمل آلفالیپوییک اسید بر پروفایل لیپیدی، استرس اکسیداتیو و اضافه بار آهن در بیمارن مبتلا به تالاسمی ماژور. طراحی: کارآزمایی بالینی متقاطع.
نحوه اجرا: بعد از اخذ رضایت نامه آگاهانه، همه شرکت کنندگان به طور تصادفی به دو گروه دریافت کننده مکمل آلفا لیپوییک اسید و دارونما به مدت 8 هفته تقسیم می شوند. بعد از یک دوره پاکسازی 3 هفته ای فاز دوم مطالعه به مدت 8 هفته آغاز و جای گروهها عوض خواهد شد. جهت ارزیابی تبعیت افراد، هر دو هفته یک بار یک ثبت 3 روزه خوراک و یک ثبت 3 روزه فعالیت فیزیکی اخذ خواهد شد. شاخص های تن سنجی و مارکرهای بیوشیمیایی در ابتدا و در پایان هر دوره اندازه گیری خواهد شد. معیارهای ورود اصلی: بیماران مبتلا به تالاسمی ماژور.
معیارهای خروج اصلی:مصرف شلاتوری به غیر از دفروکسامین، مصرف مکمل های آنتی اکسیدانی و ضد التهابی.
مداخله: از بیماران در گروه آلفالیپوییک اسید خواسته می شود که روزانه یک کپسول 600 میلی گرمی آلفالیپوییک اسید را به مدت 8 هفته مصرف کنند.
پیامدهای اصلی: سطح سرمی تری گلیسرید، کلسترول تام، لیپوپروتئین با چگالی پایین، لیپوپروتئین با چگالی بالا، مالون دی آلدهید، ظرفیت آنتی اکسیدانی تام، فریتین، آهن سرم، ظرفیت اتصالی آهن ترانسفرین، شمارش کامل خون.
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هدف: تعیین اثر مکمل آلفالیپوییک اسید بر پروفایل لیپیدی، استرس اکسیداتیو و اضافه بار آهن در بیمارن مبتلا به تالاسمی ماژور. طراحی: کارآزمایی بالینی متقاطع. نحوه اجرا: بعد از اخذ رضایت نامه آگاهانه، همه شرکت کنندگان به طور تصادفی به دو گروه دریافت کننده مکمل آلفا لیپوییک اسید و دارونما به مدت 8 هفته تقسیم می شوند. بعد از یک دوره پاکسازی 3 هفته ای فاز دوم مطالعه به مدت 8 هفته آغاز و جای گروهها عوض خواهد شد. جهت ارزیابی تبعیت افراد، هر دو هفته یک بار یک ثبت 3 روزه خوراک و یک ثبت 3 روزه فعالیت فیزیکی اخذ خواهد شد. شاخص های تن سنجی و مارکرهای بیوشیمیایی در ابتدا و در پایان هر دوره اندازه گیری خواهد شد. معیارهای ورود اصلی: بیماران مبتلا به تالاسمی ماژور. معیارهای خروج اصلی:مصرف شلاتوری به غیر از دفروکسامین، مصرف مکمل های آنتی اکسیدانی و ضد التهابی. مداخله: از بیماران در گروه آلفالیپوییک اسید خواسته می شود که روزانه یک کپسول 600 میلی گرمی آلفالیپوییک اسید را به مدت 8 هفته مصرف کنند. پیامدهای اصلی: سطح سرمی تری گلیسرید، کلسترول تام، لیپوپروتئین با چگالی پایین، لیپوپروتئین با چگالی بالا، مالون دی آلدهید، ظرفیت آنتی اکسیدانی تام، فریتین، آهن سرم، ظرفیت اتصالی آهن ترانسفرین، شمارش کامل خون.
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Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
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تعیین اثر مکمل آلفالیپوییک اسید بر پروفایل لیپیدی، استرس اکسیداتیو و اضافه بار آهن در بیمارن مبتلا به تالاسمی ماژور.
تعیین اثر مکمل آلفالیپوییک اسید بر پروفایل لیپیدی، استرس اکسیداتیو و اضافه بار آهن در بیمارن مبتلا به تالاسمی ماژور.
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Clinical trials with control group, crossover, double-blinded, randomized
Clinical trials with control group, crossover, double-blinded, randomized
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ارآزمایی بالینی دارای گروه کنترل، با گروه های متقاطع، دو سویه کور ، تصادفی شده
ارآزمایی بالینی دارای گروه کنترل، با گروه های متقاطع، دو سویه کور ، تصادفی شده
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In this double-blind clinical trial, patients with β-thalassemia major who are referred to Mohammad Kermanshahi Hospital are selected according to inclusion criteria and approved by the physician.
In this double-blind clinical trial, patients with β-thalassemia major who are referred to Mohammad Kermanshahi Hospital are selected according to inclusion criteria and approved by the physician.
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در این کارآزمایی بالینی متقاطع دو سوکور بیماران مبتلا به بتا تالاسمی ماژور مراجعه کننده به بیمارستان محمد کرمانشاهی طبق معیارهای ورود به مطالعه و با تایید پزشک، انتخاب می شوند.
در این کارآزمایی بالینی متقاطع دو سوکور بیماران مبتلا به بتا تالاسمی ماژور مراجعه کننده به بیمارستان محمد کرمانشاهی طبق معیارهای ورود به مطالعه و با تایید پزشک، انتخاب می شوند.
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Inclusion criteria include ages over 15 years old and exit criteria including the history of hepatitis B and C, heart failure and renal failure, cancer, allergies, drug-induced disordered digestive problems, pregnancy, smoking, The use of shlaturi except desphonac and following a particular diet.
Inclusion criteria include ages over 15 years old and exit criteria including the history of hepatitis B and C, heart failure and renal failure, cancer, allergies, drug-induced disordered digestive problems, pregnancy, smoking, The use of shlaturi except desphonac and following a particular diet.
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معیارهای ورود شامل سن بالای 15 سال و معیارهای خروج از مطالعه شامل سابقه ابتلا به هپاتیت B و C، نارسایی قلبی و کلیوی، سرطان، آلرژی، مشکلات گوارشی مختل کننده جذب دارو، بارداری، مصرف دخانیات، مصرف شلاتوری به غیر از دسفوناک و تبعیت از رژیم غذایی خاص می باشد.
معیارهای ورود شامل سن بالای 15 سال و معیارهای خروج از مطالعه شامل سابقه ابتلا به هپاتیت B و C، نارسایی قلبی و کلیوی، سرطان، آلرژی، مشکلات گوارشی مختل کننده جذب دارو، بارداری، مصرف دخانیات، مصرف شلاتوری به غیر از دسفوناک و تبعیت از رژیم غذایی خاص می باشد.
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At the beginning of the intervention, half of the patients will receive the alpha-lipoic acid (supplement group) and patients will be asked to take a 600 mg capsule of alpha-lipoic acid for 8 weeks each day in addition to their chelator. The other half of the patients take placebo which is apparently similar to the alpha-lipoic acid (the placebo group), these patients also receive a placebo for 8 weeks in addition to their chelator. In order to eliminate the complementary and placebo interaction, the duration of washout is considered for 3 weeks, and when it passes, the next stage of the clinical trial will begin with a crossover. In the second intervention period, the two groups will be displaced.
At the beginning of the intervention, half of the patients will receive the alpha-lipoic acid (supplement group) and patients will be asked to take a 600 mg capsule of alpha-lipoic acid for 8 weeks each day in addition to their chelator. The other half of the patients take placebo which is apparently similar to the alpha-lipoic acid (the placebo group), these patients also receive a placebo for 8 weeks in addition to their chelator. In order to eliminate the complementary and placebo interaction, the duration of washout is considered for 3 weeks, and when it passes, the next stage of the clinical trial will begin with a crossover. In the second intervention period, the two groups will be displaced.
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در ابتدای دوره مداخله به نیمی از افراد کپسول های آلفا لیپوئیک اسید داده خواهد شد (گروه مکمل) و از بیماران خواسته می شود که علاوه بر داروی شلاتور خود، هر روز یک کپسول 600 میلی گرمی آلفالیپوئیک را به مدت 8 هفته مصرف کنند. به نیمی دیگر از افراد، پلاسبو که از نظر ظاهری کاملا مشابه کپسول آلفالیپوئیک است داده می شود (گروه پلاسبو) و این بیماران نیز علاوه بر داروی شلاتور خود به مدت 8 هفته پلاسبو دریافت می نمایند. به منظور حذف اثر متقابل مکمل و پلاسبو طول دوره استراحت یا washout به مدت 3 هفته در نظر گرفته می شود که با سپری شدن آن، مرحله بعدی کارآزمایی بالینی متقاطع شروع می شود. در دوره دوم مداخله افراد 2 گروه جا به جا خواهند شد.
در ابتدای دوره مداخله به نیمی از افراد کپسول های آلفا لیپوئیک اسید داده خواهد شد (گروه مکمل) و از بیماران خواسته می شود که علاوه بر داروی شلاتور خود، هر روز یک کپسول 600 میلی گرمی آلفالیپوئیک را به مدت 8 هفته مصرف کنند. به نیمی دیگر از افراد، پلاسبو که از نظر ظاهری کاملا مشابه کپسول آلفالیپوئیک است داده می شود (گروه پلاسبو) و این بیماران نیز علاوه بر داروی شلاتور خود به مدت 8 هفته پلاسبو دریافت می نمایند. به منظور حذف اثر متقابل مکمل و پلاسبو طول دوره استراحت یا washout به مدت 3 هفته در نظر گرفته می شود که با سپری شدن آن، مرحله بعدی کارآزمایی بالینی متقاطع شروع می شود. در دوره دوم مداخله افراد 2 گروه جا به جا خواهند شد.
History of hepatitis B and C
heart failure and kidney failure
cancer
allergies
digestive problems disrupting drug intake
pregnancy
smoking
The use of shlaturi except Desphonac
following a particular diet
History of hepatitis B and C heart failure and kidney failure cancer allergies digestive problems disrupting drug intake pregnancy smoking The use of shlaturi except Desphonac following a particular diet
سابقه ابتلا به هپاتیت B و C
نارسایی قلبی و کلیوی
سرطان
آلرژی
مشکلات گوارشی مختل کننده جذب دارو
بارداری
مصرف دخانیات
مصرف شلاتوری به غیر از دسفوناک
تبعیت از رژیم غذایی خاص
سابقه ابتلا به هپاتیت B و C نارسایی قلبی و کلیوی سرطان آلرژی مشکلات گوارشی مختل کننده جذب دارو بارداری مصرف دخانیات مصرف شلاتوری به غیر از دسفوناک تبعیت از رژیم غذایی خاص
Randomization will be done using randomized block design method.
Randomization will be done using randomized block design method.
تصادفی ساری با استفاده از روش بلوک های تصادفی انجام خواهد شد.
تصادفی ساری با استفاده از روش بلوک های تصادفی انجام خواهد شد.
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Randomization will be done using randomized block design method.
Randomization will be done using randomized block design method.
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تصادفی سازی با استفاده از روش بلوک های تصادفی انجام خواهد شد.
تصادفی سازی با استفاده از روش بلوک های تصادفی انجام خواهد شد.
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In this study, none of the subjects and researchers do not know who is in what group.
In this study, none of the subjects and researchers do not know who is in what group.
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در این مطالعه هیچ یک از افراد مورد مطالعه و پژوهشگران اطلاع ندارند که چه كسي در چه گروهي قرار دارد.
در این مطالعه هیچ یک از افراد مورد مطالعه و پژوهشگران اطلاع ندارند که چه كسي در چه گروهي قرار دارد.
Primary outcomes
#1
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homocysteine (HCY)
homocysteine (HCY)
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هموسيستئين
هموسيستئين
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Week 0, Week 8, Week 11, Week 19
Week 0, Week 8, Week 11, Week 19
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ابتدای مطالعه و انتهای هفته 8، 11 و 19
ابتدای مطالعه و انتهای هفته 8، 11 و 19
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μmol/L, ELIZA
μmol/L, ELIZA
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میکرومول بر لیتر، الایزا
میکرومول بر لیتر، الایزا
#2
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Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Lipoprotein-associated phospholipase A2 (Lp-PLA2)
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فسفولیپاز A2 ليپوپروتئين
فسفولیپاز A2 ليپوپروتئين
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Week 0, Week 8, Week 11, Week 19
Week 0, Week 8, Week 11, Week 19
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ابتدای مطالعه و انتهای هفته 8، 11 و 19
ابتدای مطالعه و انتهای هفته 8، 11 و 19
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nmol/mL, ELIZA
nmol/mL, ELIZA
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نانومول بر میلی لیتر، الایزا
نانومول بر میلی لیتر، الایزا
#3
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Trimethylamine N-oxide (TMAO)
Trimethylamine N-oxide (TMAO)
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تری متیل آمین N- اکسیداز
تری متیل آمین N- اکسیداز
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Week 0, Week 8, Week 11, Week 19
Week 0, Week 8, Week 11, Week 19
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ابتدای مطالعه و انتهای هفته 8، 11 و 19
ابتدای مطالعه و انتهای هفته 8، 11 و 19
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μmol/L, ELIZA
μmol/L, ELIZA
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میکرومول بر لیتر، الایزا
میکرومول بر لیتر، الایزا
#4
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Osteoprotegerin (OPG)
Osteoprotegerin (OPG)
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استئوپروتگرین
استئوپروتگرین
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Week 0, Week 8, Week 11, Week 19
Week 0, Week 8, Week 11, Week 19
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ابتدای مطالعه و انتهای هفته 8، 11 و 19
ابتدای مطالعه و انتهای هفته 8، 11 و 19
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mg/dl, ELIZA
mg/dl, ELIZA
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میلی گرم بر دسی لیتر، الایزا
میلی گرم بر دسی لیتر، الایزا
Recruitment centers
#1
Name of recruitment center - English: Mohammad Kermanshahi Hospital
Name of recruitment center - Persian: بیمارستان محمد کرمانشاهی
Full name of responsible person - English: Elham Sharifi Zahabi
Full name of responsible person - Persian: الهام شریفی ذهابی
Street address - English: Mohammad Kermanshahi Hospital, Mosavari Avenue, Kermanshah
Street address - Persian:
City - English: Kermanshah
City - Persian: کرمانشاه
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Mohammad Kermanshahi Hospital
Name of recruitment center - Persian: بیمارستان محمد کرمانشاهی
Full name of responsible person - English: Elham Sharifi Zahabi
Full name of responsible person - Persian: الهام شریفی ذهابی
Street address - English: Mohammad Kermanshahi Hospital, Mosavari Avenue, Kermanshah
Street address - Persian: بیمارستان محمد کرمانشاهی، خیابان مصوری، کرمانشاه
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 0
Phone: +98 83 3721 8204
Fax:
Email: khadijeh.jamshidi93@gmail.com
Web page address:
Name of recruitment center - English: Mohammad Kermanshahi Hospital Name of recruitment center - Persian: بیمارستان محمد کرمانشاهی Full name of responsible person - English: Elham Sharifi Zahabi Full name of responsible person - Persian: الهام شریفی ذهابی Street address - English: Mohammad Kermanshahi Hospital, Mosavari Avenue, Kermanshah Street address - Persian: بیمارستان محمد کرمانشاهی، خیابان مصوری، کرمانشاه City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 0 Phone: +98 83 3721 8204 Fax: Email: khadijeh.jamshidi93@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Kermanshah University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person - English: Behrooz Hamzeh
Full name of responsible person - Persian: بهروز حمزه
Street address - English: Deputy of Research and Technology- Kermanshah University Of Medical Sciences- Shahid Beheshti Blvd.
Street address - Persian: بلوار شهید بهشتی ساختمان شماره 2 معاونت تحقیقات و فناوری
City - English: Kermanshah
City - Persian: کرمانشاه
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: Behrooz Hamzeh
Full name of responsible person - Persian: بهروز حمزه
Street address - English: Deputy of Research and Technology- Kermanshah University Of Medical Sciences- Shahid Beheshti Blvd.
Street address - Persian: بلوار شهید بهشتی ساختمان شماره 2 معاونت تحقیقات و فناوری
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 0
Phone: +98 83 1725 7696
Fax:
Email: kbehrooz.hamzeh@kums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kermanshah University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه Full name of responsible person - English: Behrooz Hamzeh Full name of responsible person - Persian: بهروز حمزه Street address - English: Deputy of Research and Technology- Kermanshah University Of Medical Sciences- Shahid Beheshti Blvd. Street address - Persian: بلوار شهید بهشتی ساختمان شماره 2 معاونت تحقیقات و فناوری City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 0 Phone: +98 83 1725 7696 Fax: Email: kbehrooz.hamzeh@kums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Kermanshah University Of Medical Sciences
Kermanshah University of Medical Sciences
Kermanshah University Ofof Medical Sciences
دانشگاه علوم پزشکی کرمانشاه
دانشگاه علوم پزشکی کرمانشاه
دانشگاه علوم پزشکی کرمانشاه
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: School of Nutrition and Food Sciences-Kermanshah University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه_ دانشکده علوم تغذیه و صنایع غذایی
Full name of responsible person - English: Hadi Abdollahzad
Full name of responsible person - Persian: هادی عبداله زاد
Position - English: Assistant Professor/ PhD
Position - Persian: PhD_ استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Square-Kermanshah
Street address - Persian: کرمانشاه -میدان ایثار- جنب بیمارستان فارابی- دانشکده علوم تغذیه و صنایع غذایی
City - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Squre-Kermanshah
City - Persian: کرمانشاه
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 83 3826 2052
Mobile: 00
Fax:
Email: Hadi_Nut@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hadi Abdollahzad
Full name of responsible person - Persian: هادی عبداله زاد
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Square-Kermanshah
Street address - Persian: کرمانشاه -میدان ایثار- جنب بیمارستان فارابی- دانشکده علوم تغذیه و صنایع غذایی
City - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Squre-Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 0
Phone: +98 83 3826 2052
Mobile: 00
Fax:
Email: Hadi_Nut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: School of Nutrition and Food Sciences-Kermanshah University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه_ دانشکده علوم تغذیه و صنایع غذایی Full name of responsible person - English: Hadi Abdollahzad Full name of responsible person - Persian: هادی عبداله زاد Position - English: Assistant Professor/ PhD Position - Persian: PhD_ استادیار Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Square-Kermanshah Street address - Persian: کرمانشاه -میدان ایثار- جنب بیمارستان فارابی- دانشکده علوم تغذیه و صنایع غذایی City - English: School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Squre-Kermanshah City - Persian: کرمانشاه Province: Kermanshah Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 0 Phone: +98 83 3826 2052 Mobile: 00 Fax: Email: Hadi_Nut@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: School of Nutrtion and Food Sciences- Kermanshah University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه_ دانشکده علوم تغذیه و صنایع غذایی
Full name of responsible person - English: Hadi Abdollahzad
Full name of responsible person - Persian: هادی عبداله زاد
Position - English: Assistant Professor/ PhD
Position - Persian: استادیار/PhD
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nutrtion and Food Sciences- Next to Farabi Hospital- Isar Square-Kermanshah
Street address - Persian: کرمانشاه - میدان ایثار - جنب بیمارستان فارابی - دانشکده علوم تغذیه و صنایع غذایی
City - English: Kermanshah
City - Persian: کرمانشاه
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 83 3826 2052
Mobile: 00
Fax:
Email: hadi_nut@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hadi Abdollahzad
Full name of responsible person - Persian: هادی عبداله زاد
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nutrtion and Food Sciences- Next to Farabi Hospital- Isar Square-Kermanshah
Street address - Persian: کرمانشاه - میدان ایثار - جنب بیمارستان فارابی - دانشکده علوم تغذیه و صنایع غذایی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 0
Phone: +98 83 3826 2052
Mobile: 00
Fax:
Email: hadi_nut@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: School of Nutrtion and Food Sciences- Kermanshah University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه_ دانشکده علوم تغذیه و صنایع غذایی Full name of responsible person - English: Hadi Abdollahzad Full name of responsible person - Persian: هادی عبداله زاد Position - English: Assistant Professor/ PhD Position - Persian: استادیار/PhD Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nutrtion and Food Sciences- Next to Farabi Hospital- Isar Square-Kermanshah Street address - Persian: کرمانشاه - میدان ایثار - جنب بیمارستان فارابی - دانشکده علوم تغذیه و صنایع غذایی City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 0 Phone: +98 83 3826 2052 Mobile: 00 Fax: Email: hadi_nut@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Imam khomeini Comprehensive Health center
Name of organization / entity - Persian: مرکز جامع سلامت اما خمینی (ره)
Full name of responsible person - English: Elham Sharifi Zahabi
Full name of responsible person - Persian: الهام شریفی ذهابی
Position - English: MSc
Position - Persian: کارشناس ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam khomeini Town- Kermanshah
Street address - Persian: کرمانشاه- شهرک امام خمینی
City - English: Kermanshah
City - Persian: کرمانشاه
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: 00
Mobile: +98 901 155 1189
Fax:
Email: elham_sharifi@nutr.mui.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Imam khomeini Comprehensive Health center
Name of organization / entity - Persian: مرکز جامع سلامت اما خمینی (ره)
Full name of responsible person - English: Elham Sharifi Zahabi
Full name of responsible person - Persian: الهام شریفی ذهابی
Position - English: MSc
Position - Persian: کارشناس ارشد
Latest degree: master
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Imam khomeini Town- Kermanshah
Street address - Persian: کرمانشاه- شهرک امام خمینی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: 00
Mobile: +98 901 155 1189
Fax:
Email: elham_sharifi@nutr.mui.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Imam khomeini Comprehensive Health center Name of organization / entity - Persian: مرکز جامع سلامت اما خمینی (ره) Full name of responsible person - English: Elham Sharifi Zahabi Full name of responsible person - Persian: الهام شریفی ذهابی Position - English: MSc Position - Persian: کارشناس ارشد Latest degree: master Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Imam khomeini Town- Kermanshah Street address - Persian: کرمانشاه- شهرک امام خمینی City - English: Kermanshah City - Persian: کرمانشاه Province: Kermanshah Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: Iran Phone: 00 Mobile: +98 901 155 1189 Fax: Email: elham_sharifi@nutr.mui.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
na
na
no
no
yes
yes
na
na
na
na
empty
All data is unobtrusive when unrecognizable
All data is unobtrusive when unrecognizable
empty
کل داده ها پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
کل داده ها پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
empty
Start the access period after printing the results
Start the access period after printing the results
empty
شروع دوره دسترسی پس از چاپ نتایج
شروع دوره دسترسی پس از چاپ نتایج
empty
All people have permission to access
All people have permission to access
empty
همه افراد اجازه دسترسی دارند
همه افراد اجازه دسترسی دارند
empty
In case of confidentiality of data
In case of confidentiality of data
empty
در صورت محرمانه ماندن داده ها
در صورت محرمانه ماندن داده ها
empty
hadi_nut@yahoo.com
hadi_nut@yahoo.com
empty
hadi_nut@yahoo.com
hadi_nut@yahoo.com
empty
By submitting a request to the researcher, the relevant request will be reviewed.
By submitting a request to the researcher, the relevant request will be reviewed.
empty
با ارسال درخواست به محقق درخواست مربوطه بررسی خواهد شد.
با ارسال درخواست به محقق درخواست مربوطه بررسی خواهد شد.
Protocol summary
Study aim
Evaluation the effects of alpha lipoic acid on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
Design
Clinical trials with control group, crossover, double-blinded, randomized
Settings and conduct
In this double-blind clinical trial, patients with β-thalassemia major who are referred to Mohammad Kermanshahi Hospital are selected according to inclusion criteria and approved by the physician.
Participants/Inclusion and exclusion criteria
Inclusion criteria include ages over 15 years old and exit criteria including the history of hepatitis B and C, heart failure and renal failure, cancer, allergies, drug-induced disordered digestive problems, pregnancy, smoking, The use of shlaturi except desphonac and following a particular diet.
Intervention groups
At the beginning of the intervention, half of the patients will receive the alpha-lipoic acid (supplement group) and patients will be asked to take a 600 mg capsule of alpha-lipoic acid for 8 weeks each day in addition to their chelator. The other half of the patients take placebo which is apparently similar to the alpha-lipoic acid (the placebo group), these patients also receive a placebo for 8 weeks in addition to their chelator. In order to eliminate the complementary and placebo interaction, the duration of washout is considered for 3 weeks, and when it passes, the next stage of the clinical trial will begin with a crossover. In the second intervention period, the two groups will be displaced.
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of alpha lipoic acid or placebo on lipid profile, oxidative stress and iron overload in patients with β-thalassemia major.
Public title
Effects of alpha lipoic acid on β- Thalassemia Major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 15 years
Exclusion criteria:
History of hepatitis B and C
heart failure and kidney failure
cancer
allergies
digestive problems disrupting drug intake
pregnancy
smoking
The use of shlaturi except Desphonac
following a particular diet
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using randomized block design method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, none of the subjects and researchers do not know who is in what group.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd- Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
0
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
KUMS.REC.1396.144
Health conditions studied
1
Description of health condition studied
β-thalassemia Major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
nmol/ml, ELIZA
2
Description
Malondialdehyde
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
nm/ml, Tiobarbitoric acid
3
Description
Serum Iron
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μmol/ml, photometric
4
Description
Ferritin
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
ngram/ml, ELIAZ
5
Description
Transferrin
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μgram/ml, ELIZA
6
Description
homocysteine (HCY)
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μmol/L, ELIZA
7
Description
Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
nmol/mL, ELIZA
8
Description
Trimethylamine N-oxide (TMAO)
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
μmol/L, ELIZA
9
Description
Osteoprotegerin (OPG)
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, ELIZA
Secondary outcomes
1
Description
Serum Triacylglyceride
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Enzymatic
2
Description
Serum Cholesterol
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Enzymatic
3
Description
HDL-c
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, Direct Enzymatic
4
Description
LDL-c
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
mg/dl, FriedWald Formula
5
Description
Body Weight
Timepoint
Week 0, Week 8, Week 11, Week 19
Method of measurement
Scale, Kilogram
Intervention groups
1
Description
Intervention group: 600 mg alpha lipoic acid (C8H14O2S2) capsules once a day for 8 weeks. Product of Support Nutrition company, USA.
Category
Treatment - Other
2
Description
Control group: 600 mg placebo capsules (corn flour ) similar to alpha lipoic acid in shape and color once a day for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Elham Sharifi Zahabi
Street address
Mohammad Kermanshahi Hospital, Mosavari Avenue, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
0
Phone
+98 83 3721 8204
Email
khadijeh.jamshidi93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Deputy of Research and Technology- Kermanshah University Of Medical Sciences- Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
0
Phone
+98 83 1725 7696
Email
kbehrooz.hamzeh@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hadi Abdollahzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Square-Kermanshah
City
School of Nutrition and Food Sciences-Next to the Farabi hospital- Isar Squre-Kermanshah
Province
Kermanshah
Postal code
0
Phone
+98 83 3826 2052
Fax
Email
Hadi_Nut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hadi Abdollahzad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrtion and Food Sciences- Next to Farabi Hospital- Isar Square-Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
0
Phone
+98 83 3826 2052
Fax
Email
hadi_nut@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam khomeini Comprehensive Health center
Full name of responsible person
Elham Sharifi Zahabi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Imam khomeini Town- Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
Iran
Phone
00
Fax
Email
elham_sharifi@nutr.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is unobtrusive when unrecognizable
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
All people have permission to access
Under which criteria data/document could be used
In case of confidentiality of data
From where data/document is obtainable
hadi_nut@yahoo.com
What processes are involved for a request to access data/document
By submitting a request to the researcher, the relevant request will be reviewed.