The effects of combined zinc and magnesium 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 Shabihkhani Clinic affiliated to Kashan 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 Naghavi outpatient Clinic affiliated to Kashan 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 ShabihkhaniNaghavi outpatient Clinic affiliated to Kashan 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 شبیه خوانی وابسته به دانشگاه علوم پزشکی کاشان، 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 نقوی وابسته به دانشگاه علوم پزشکی کاشان، 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 شبیه خوانیسرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، 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: Individuals with neoplastic disorders, cardiovascular diseases, malabsorptive disorders, and current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Individuals with androgen-secreting tumors, CVD and diabetes, thyroid dysfunction, and pregnant women.
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Individuals with neoplastic disordersandrogen-secreting tumors, cardiovascular diseasesCVD and diabetes, malabsorptive disordersthyroid dysfunction, and current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medicationspregnant women.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به 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.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: افراد مبتلا به تومورهای ترشح کننده آندروژن، بیماریهای قلبی-عروقی و دیابت، اختلال در عملکرد تیروئید، زنان باردار.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: افراد مبتلا به اختلالات نئوپلاستیکتومورهای ترشح کننده آندروژن، بیماریهای قلبی-عروقی، اختلالات سوء جذبی، استفاده اخیر یا قبلا (در ظرف 6 ماه گذشته) از هورمون؛ داروهای ضد دیابتیک و داروهای ضد چاقیدیابت، اختلال در عملکرد تیروئید، زنان باردار.
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات، 220 میکروگرم، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات (شرکت دارویی الهاوی، تهران، ایران)، 220 میلی گرم، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات (شرکت دارویی الهاوی، تهران، ایران)، 220 میکروگرممیلی گرم، روزانه، به صورت خوراکی برای 12 هفته. گروه کنترل: پلاسبو، روزانه، به صورت خوراکی برای 12 هفته.
General information
Individuals with neoplastic disorders
cardiovascular diseases
malabsorptive disorders
current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.
Androgen-secreting tumors
cardiovascular diseases and diabetes
Pregnant women
Thyroid dysfunction
Individuals with neoplastic disordersAndrogen-secreting tumors cardiovascular diseases malabsorptive disorders current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.diabetes Pregnant women Thyroid dysfunction
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.
تومورهای ترشح کننده آندروژن
بیماریهای قلبی-عروقی و دیابت
زنان باردار
اختلال در عملکرد تیروئید
افراد مبتلا به اختلالات نئوپلاستیکتومورهای ترشح کننده آندروژن بیماریهای قلبی-عروقی اختلالات سوء جذبی استفاده اخیر یا قبلا (و دیابت زنان باردار اختلال در ظرف 6 ماه گذشته) از هورمون؛ داروهای ضد دیابتیک و داروهای ضد چاقی.عملکرد تیروئید
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shabihkhani clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at Naghavi outpatient clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the ShabihkhaniNaghavi outpatient clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شبیه خوانی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک سرپایی نقوی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شبیه خوانیسرپایی نقوی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
Intervention groups
#1
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات، 220 میکروگرم، روزانه، به صورت خوراکی برای 12 هفته
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات، 220 میلی گرم، روزانه، به صورت خوراکی برای 12 هفته
گروه مداخله: 250 میلی گرم منیزیم اکسید (قرن 21، آریزونا، آمریکا) + مکمل روی سولفات، 220 میکروگرممیلی گرم، روزانه، به صورت خوراکی برای 12 هفته
Recruitment centers
#1
Name of recruitment center - English: Shabihkhani Clinic
Name of recruitment center - Persian: کلینیک شبیه خوانی
Full name of responsible person - English: Dr. Fatemeh Foroozafard
Full name of responsible person - Persian: دکتر فاطمه فروزانفرد
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: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: forozanfar_f@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi outpatient Clinic
Name of recruitment center - Persian: کلینیک سرپایی نقوی
Full name of responsible person - English: Dr. Fatemeh Foroozafard
Full name of responsible person - Persian: دکتر فاطمه فروزانفرد
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: 1771844351
Phone: +98 31 5546 3378
Fax:
Email: forozanfar_f@kaums.ac.ir
Web page address:
Name of recruitment center - English: ShabihkhaniNaghavi outpatient Clinic Name of recruitment center - Persian: کلینیک شبیه خوانیسرپایی نقوی Full name of responsible person - English: Dr. Fatemeh Foroozafard Full name of responsible person - Persian: دکتر فاطمه فروزانفرد 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: 1771844351 Phone: +98 31 5546 3378 Fax: Email: forozanfar_f@kaums.ac.ir Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of combined magnesium and zinc 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, 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 groups. Randomization will be done by the use of computer software.
Settings and conduct
Among patients with polycystic ovary syndrome referred to Naghavi outpatient Clinic affiliated to Kashan 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: Individuals with androgen-secreting tumors, CVD and diabetes, thyroid dysfunction, and pregnant women.
Intervention groups
Intervention group: 250 mg magnesium oxide (21st Century, Arizona, USA) + 220 mg of zinc sulfate (Alhavi Pharmaceutical Company, Tehran, Iran) daily, for 12 weeks orally. Control group: Placebo, 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:IRCT20170513033941N40
Registration date:2018-10-31, 1397/08/09
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:1
Registration date
2018-10-31, 1397/08/09
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
2018-07-31, 1397/05/09
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of combined zinc and magnesium supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Public title
Effect of combined zinc and magnesium supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years.
Exclusion criteria:
Androgen-secreting tumors
cardiovascular diseases and diabetes
Pregnant women
Thyroid dysfunction
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at Naghavi outpatient clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Approval date
2018-07-30, 1397/05/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.026
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 Triglycerides
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: 250 mg magnesium oxide (21st Century, Arizona, USA) + 220 mg of zinc sulfate (Alhavi Pharmaceutical Company, Tehran, Iran) daily, for 12 weeks orally
Category
Treatment - Drugs
2
Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi outpatient Clinic
Full name of responsible person
Dr. Fatemeh Foroozafard
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
forozanfar_f@kaums.ac.ir
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
1771844351
Phone
+98 31 5546 3378
Email
Gholamali_h@kaums.ac.ir
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
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
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
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
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
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