Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus
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Protocol summary
Among patients with gestational diabetes referred to Naghavi 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 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Among patients with gestational diabetes referred to Naghavi gynecology 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 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Among patients with gestational diabetes referred to Naghavi gynecology 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 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک 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. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک زنان 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. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته.
از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک زنان 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. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته.
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism.
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperateTaking zinc and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: معیار عدم ورود به مطالعه: گرفتن مکمل های روی و ویتامین E سه ماه قبل مداخله، نیاز به انسولین درمانی در طول مداخله، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: معیار عدم تمایلورود به همکاریمطالعه: گرفتن مکمل های روی و ویتامین E سه ماه قبل مداخله، نیاز به انسولین درمانی در طول مداخله، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید.
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of glycemic control (primary outcomes) and lipid profile and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of insulin metabolismglycemic control (primary outcomes) and lipid profile and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل لیپیدی، بیان ژن مرتبط با انسولین و لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای گلیسمیک کنترل (پیامدهای اولیه) و پروفایل لیپیدی، بیان ژن مرتبط با انسولین و لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای متابولیسم انسولینگلیسمیک کنترل (پیامدهای اولیه) و پروفایل لیپیدی، بیان ژن مرتبط با انسولین و لیپید (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
2
3
23
Exclusion criteria: Unwillingness to cooperate.
Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention
Insulin therapy required during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Exclusion criteria: Unwillingness to cooperate.Taking zinc and vitamin E supplements 3 months before the intervention Insulin therapy required during the intervention Pre-eclampsia Eclampsia Hypo and hyperthyroidism
معیار خروج از مطالعه: عدم تمایل به همکاری.
معیار عدم ورود به مطالعه: گرفتن مکمل های روی و/یا ویتامین E سه ماه قبل مداخله
نیاز به انسولین درمانی در طول مداخله
پری اکلامپسی
اکلامپسی
کم کاری و پرکاری تیروئید
معیار خروج ازعدم ورود به مطالعه: عدم تمایلگرفتن مکمل های روی و/یا ویتامین E سه ماه قبل مداخله نیاز به همکاری.انسولین درمانی در طول مداخله پری اکلامپسی اکلامپسی کم کاری و پرکاری تیروئید
Randomization will be done by the use of computer-generated random numbers.
To decrease potential confounding effects, after balanced blocked randomisation, all 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, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers software.
تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، بعد از تصادفی سازی بلوکی بالانس شده، همه شرکت کنندگان 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 بلوکی بالانس شده، همه شرکت کنندگان به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوترنرم افزار کامپیوتری انجام خواهد شد.
Secondary outcomes
#1
Expressed levels of GLUT-1 gene
LDL-cholesterol
Expressed levels of GLUTLDL-1 genecholesterol
سطوح بیان GLUT-1
کلسترول LDL
سطوح بیان GLUT-1کلسترول LDL
PCR
Enzymatic kit
PCREnzymatic kit
PCR
کیت آنزیمی
PCRکیت آنزیمی
#2
Expressed levels of Lp(a) gene
VLDL-cholesterol
Expressed levels of Lp(a) geneVLDL-cholesterol
سطوح بیان (Lp(a
کلسترول VLDL
سطوح بیان (Lp(aکلسترول VLDL
PCR
Enzymatic kit
PCREnzymatic kit
PCR
کیت آنزیمی
PCRکیت آنزیمی
#3
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
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Mansoreh Samimi
Full name of responsible person - Persian: منصوره صمیمی
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: 8115187159
Phone: +98 31 4446 0180
Fax:
Email: samimi_m@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi gynecology Clinic
Name of recruitment center - Persian: کلینیک زنان نقوی
Full name of responsible person - English: Mansoreh Samimi
Full name of responsible person - Persian: منصوره صمیمی
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: 8115187159
Phone: +98 31 4446 0180
Fax:
Email: samimi_m@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi gynecology Clinic Name of recruitment center - Persian: کلینیک زنان نقوی Full name of responsible person - English: Mansoreh Samimi Full name of responsible person - Persian: منصوره صمیمی 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: 8115187159 Phone: +98 31 4446 0180 Fax: Email: samimi_m@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: National Institute for Medical Research Development of Iran (NIMAD)
Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران
Full name of responsible person - English: Dr. Reza Malekzadeh
Full name of responsible person - Persian: دکتر رضا ملک زاده
Street address - English: National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
Street address - Persian: تهران، خیابان فاطمی، موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۶۹۳۱۱۱
Phone: +98 21 6693 8037
Fax:
Email: malek@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: National Institute for Medical Research Development of Iran (NIMAD)
Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران
Full name of responsible person - English: Dr. Reza Malekzadeh
Full name of responsible person - Persian: دکتر رضا ملک زاده
Street address - English: National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
Street address - Persian: تهران، خیابان فاطمی، موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419693111
Phone: +98 21 6693 8037
Fax:
Email: malek@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: National Institute for Medical Research Development of Iran (NIMAD) Name of organization / entity - Persian: موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران Full name of responsible person - English: Dr. Reza Malekzadeh Full name of responsible person - Persian: دکتر رضا ملک زاده Street address - English: National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran Street address - Persian: تهران، خیابان فاطمی، موسسه ملی توسعه تحقیقات علوم پزشکی جمهوری اسلامی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۶۹۳۱۱۱1419693111 Phone: +98 21 6693 8037 Fax: Email: malek@tums.ac.ir Web page address:
Sharing plan
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of combined vitamin E and zinc supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with gestational diabetes mellitus.
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 combined vitamin E and zinc supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes referred to Naghavi gynecology 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 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism.
Intervention groups
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Main outcome variables
Outcomes: Markers of glycemic control (primary outcomes) and lipid profile 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:IRCT20170513033941N26
Registration date:2018-01-07, 1396/10/17
Registration timing:retrospective
Last update:2019-09-22, 1398/06/31
Update count:1
Registration date
2018-01-07, 1396/10/17
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
2017-11-27, 1396/09/06
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus
Public title
Effect of combined vitamin E and zinc supplementation in treatment of gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Taking zinc and vitamin E supplements 3 months before the intervention
Insulin therapy required during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
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, after balanced blocked randomisation, all 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 National Institute for Medical Research Development of Iran (NIMAD)
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.NIMAD.REC.1396.133
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 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 6 weeks of intervention
Method of measurement
PCR
5
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
VLDL-cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi gynecology Clinic
Full name of responsible person
Mansoreh Samimi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Fax
Email
samimi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development of Iran (NIMAD)
Full name of responsible person
Dr. Reza Malekzadeh
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6693 8037
Email
malek@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development of Iran (NIMAD)
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
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
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