Clinical trial of the effect of chromium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome candidate for IVF
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Protocol summary
Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: unwillingness to cooperate.
Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: Thyroid dysfunction, diabetes or impaired glucose tolerance .
Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: unwillingness to cooperateThyroid dysfunction, diabetes or impaired glucose tolerance .
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF 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 کاندید IVF در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: اختلال در عملکرد تیروئید، دیابت یا اختلال در تحمل گلوکز.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاریاختلال در عملکرد تیروئید، دیابت یا اختلال در تحمل گلوکز.
Intervention group: Chromium supplements (21st Century, Arizona, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
Intervention group: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
Intervention group: Chromium supplements (21st CenturyNature Made, ArizonaCalifornia, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
گروه مداخله: مکمل کروم (قرن 21، آریزونا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، روزانه به صورت خوراکی برای 8 هفته.
گروه مداخله: مکمل کروم (نیچر مید، کالیفرنیا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، روزانه به صورت خوراکی برای 8 هفته.
گروه مداخله: مکمل کروم (قرن 21نیچر مید، آریزوناکالیفرنیا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته. گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، روزانه به صورت خوراکی برای 8 هفته.
General information
Unwillingness to cooperate.
Thyroid dysfunction
Diabetes or impaired glucose tolerance
Unwillingness to cooperate.Thyroid dysfunction Diabetes or impaired glucose tolerance
عدم تمایل به همکاری.
اختلال در عملکرد تیروئید
دیابت یا اختلال در تحمل گلوکز
عدم تمایل به همکاری.اختلال در عملکرد تیروئید دیابت یا اختلال در تحمل گلوکز
At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline, after balanced randomisation, subjects will be allocated into two groups to receive supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
At study baseline and, after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y)balanced randomisation, subjects will be randomly dividedallocated into two groups to receive supplementsupplements or placebo. Randomization will be done by the use of computer-generated random numbers.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30)، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه، بعد از تصادفی سازی بالانس شده، افراد برای دریافت مکمل و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و، بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30)تصادفی سازی بالانس شده، افراد به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
Secondary outcomes
#1
Expressed levels of ox-LDL gene
Expressed levels of LDLR gene
Expressed levels of ox-LDLLDLR gene
سطوح بیان ox-LDL
سطوح بیان LDLR
سطوح بیان ox-LDLLDLR
#2
Expressed levels of LP(a) gene
Expressed levels of TNF-α gene
Expressed levels of LP(a)TNF-α gene
سطوح بیان (LP(a
سطوح بیان TNF-α
سطوح بیان (LP(aTNF-α
#3
empty
Expressed levels of IL-1 gene
Expressed levels of IL-1 gene
empty
سطوح بیان IL-1
سطوح بیان IL-1
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
empty
در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#4
empty
Expressed levels of IL-8 gene
Expressed levels of IL-8 gene
empty
سطوح بیان IL-8
سطوح بیان IL-8
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
empty
در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#5
empty
Expressed levels of TGF-β gene
Expressed levels of TGF-β gene
empty
سطوح بیان TGF-β
سطوح بیان TGF-β
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
empty
در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
#6
empty
Expressed levels of VEGF gene
Expressed levels of VEGF gene
empty
سطوح بیان VEGF
سطوح بیان VEGF
empty
At the beginning of the study and after 8 weeks of intervention
At the beginning of the study and after 8 weeks of intervention
empty
در ابتدای مطالعه و 8 هفته بعد از مداخله
در ابتدای مطالعه و 8 هفته بعد از مداخله
empty
PCR
PCR
empty
PCR
PCR
Intervention groups
#1
Intervention group: Chromium supplements (21st Century, Arizona, USA), 200 µg, daily, for 8 weeks orally.
گروه مداخله: مکمل کروم (قرن 21، آریزونا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: مکمل کروم (نیچر مید، کالیفرنیا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته.
گروه مداخله: مکمل کروم (قرن 21نیچر مید، آریزوناکالیفرنیا، آمریکا)، 200 میکروگرم، روزانه، به صورت خوراکی برای 8 هفته.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی
Street address - English: Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
Street address - Persian: بزرگراه چمران، خیابان یمن، ولنجک، دانشگاه علوم پزشکی شهید یهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 21 2243 2560
Fax:
Email: Modarres.sh@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Afshin Zarghi
Full name of responsible person - Persian: افشین زرقی
Street address - English: Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
Street address - Persian: بزرگراه چمران، خیابان یمن، ولنجک، دانشگاه علوم پزشکی شهید یهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1771844351
Phone: +98 21 2243 2560
Fax:
Email: Zarghi.A@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice Chancellor for research of Shahid Beheshti University of Medical SciencesAfshin Zarghi Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتیافشین زرقی Street address - English: Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway Street address - Persian: بزرگراه چمران، خیابان یمن، ولنجک، دانشگاه علوم پزشکی شهید یهشتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1771844351 Phone: +98 21 2243 2560 Fax: Email: Modarres.shZarghi.A@gmail.com Web page address:
Protocol summary
Study aim
The aim of this study is to determine the effects of chromium supplementation on gene expression related to insulin and lipid in patients with polycystic ovary syndrome candidate for IVF.
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 chromium supplements (n=20) or placebo (n=20)
Settings and conduct
Among patients with polycystic ovary syndrome candidate for IVF referred to Taleghani Clinic affiliated to Shahid Beheshti University of Medical Sciences, 40 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 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criterion: Thyroid dysfunction, diabetes or impaired glucose tolerance .
Intervention groups
Intervention group: Chromium supplements (Nature Made, California, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) once a day for 8 weeks orally.
Main outcome variables
Gene expression related to insulin (primary outcomes) and gene expression related to 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:IRCT20170513033941N32
Registration date:2018-04-05, 1397/01/16
Registration timing:retrospective
Last update:2019-09-13, 1398/06/22
Update count:1
Registration date
2018-04-05, 1397/01/16
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
2018-02-27, 1396/12/08
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of chromium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome candidate for IVF
Public title
Effect of chromium supplementation in treatment of patients with polycystic ovary syndrome candidate for IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years old
Exclusion criteria:
Thyroid dysfunction
Diabetes or impaired glucose tolerance
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline, after balanced randomisation, subjects will be allocated into two groups to receive supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1771844351
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1292
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
Polycystic
ICD-10 code description
E28.2
Primary outcomes
1
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of TNF-α gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
3
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
4
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 8 weeks of intervention