Clinical trial of the effect of combined chromium and carnitine supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
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Protocol summary
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Among patients with polycystic ovary syndrome referred to Taleghani outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Among patients with polycystic ovary syndrome referred to KosarTaleghani outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک سرپایی طالقانی وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک ارجاع شده به کلینیک کوثرسرپایی طالقانی وابسته به دانشگاه علوم پزشکی اراک، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل 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.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperatePregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: بارداری، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینیمیا، اختلال در عملکرد تیروئید، دیابت.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاریبارداری، هیپرپلازی آدرنال، تومورهای ترشح کننده آندروژن، هیپرپرولاکتینیمیا، اختلال در عملکرد تیروئید، دیابت.
General information
Exclusion criteria: Individuals with neoplastic disorders
cardiovascular diseases
malabsorptive disorders
current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.
Exclusion criteria: Individuals with neoplastic disorders cardiovascular diseases malabsorptive disorders current or previous (within the last 6 months) use of hormonal; antidiabetic and antiPregnancy Adrenal hyperplasia Androgen-obesity medications.secreting tumors Thyroid dysfunction Diabetes Hyperprolactinemia
معیار خروج از مطالعه: افراد مبتلا به اختلالات نئوپلاستیک
بیماریهای قلبی-عروقی
اختلالات سوء جذبی
استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون؛ داروهای ضد دیابتیک و داروهای ضد چاقی.
بارداری
هیپرپلازی آدرنال
تومورهای ترشح کننده آندروژن
اختلال در عملکرد تیروئید
دیابت
هیپرپرولاکتینیمیا
معیار خروج از مطالعه: افراد مبتلا به اختلالات نئوپلاستیک بیماریهای قلبی-عروقی اختلالات سوء جذبی استفاده اخیر یا قبلا (بارداری هیپرپلازی آدرنال تومورهای ترشح کننده آندروژن اختلال در ظرف 6 ماه گذشته) از هورمون؛ داروهای ضد دیابتیک و داروهای ضد چاقی.عملکرد تیروئید دیابت هیپرپرولاکتینیمیا
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
To decrease potential confounding effects, after balanced randomisation, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
To decrease potential confounding effects, allafter balanced randomisation, participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بالانس شده، افراد به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30)بعد از تصادفی سازی لایه ای خواهند شد. سپسبالانس شده، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Kosar Clinic
Name of recruitment center - Persian: کلینیک کوثر
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: jamilian.mehri@gmail.com
Web page address:
Name of recruitment center - English: Taleghani outpatient Clinic
Name of recruitment center - Persian: کلینیک سرپایی طالقانی
Full name of responsible person - English: Mehri Jamilian
Full name of responsible person - Persian: مهری جمیلیان
Street address - English: Emam Khomeyni Avenue, Arak
Street address - Persian: اراک، خیابان امام خمینی
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: jamilian.mehri@gmail.com
Web page address:
Name of recruitment center - English: KosarTaleghani outpatient Clinic Name of recruitment center - Persian: کلینیک کوثرسرپایی طالقانی Full name of responsible person - English: Mehri Jamilian Full name of responsible person - Persian: مهری جمیلیان Street address - English: Emam Khomeyni Avenue, Arak Street address - Persian: اراک، خیابان امام خمینی City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 31 5546 3378 Fax: Email: jamilian.mehri@gmail.com Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of combined chromium and carnitine supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplements (n=30) or placebo (n=30).
Settings and conduct
Among patients with polycystic ovary syndrome referred to Taleghani outpatient Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Pregnancy, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes.
Intervention groups
Intervention group: 200 µg chromium (21st Century, Arizona, USA) and 1000 mg carnitine (Avecina, Tehran, Iran) daily for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N38
Registration date:2018-09-26, 1397/07/04
Registration timing:retrospective
Last update:2019-09-24, 1398/07/02
Update count:1
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-11, 1397/03/21
Expected recruitment end date
2018-06-26, 1397/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined chromium and carnitine supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Public title
Effect of combined chromium and carnitine supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years.
To decrease potential confounding effects, after balanced randomisation, participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.ARAKMU.REC.1397.079
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
2
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
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
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of LDL-R gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 200 µg chromium (21st Century, Arizona, USA) and 1000 mg carnitine (Avecina, Tehran, Iran) daily for 12 weeks orally
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani outpatient Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
jamilian.mehri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
Arjomandzadegan.M@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available