Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in women with gestational diabetes mellitus
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Protocol summary
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. Exclusion criteria: Taking magnesium and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperateTaking magnesium and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
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: گرفتن مکمل های منیزیم و ویتامین E سه ماه قبل مداخله، نیاز به انسولین درمانی در طول مداخله، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، سیگاری ها.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایلگرفتن مکمل های منیزیم و ویتامین E سه ماه قبل مداخله، نیاز به همکاریانسولین درمانی در طول مداخله، پری اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، سیگاری ها.
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of glycemic control (primary outcomes) and lipid profile (secondary outcomes) will be quantified at study baseline and end-of-trial.
Outcomes: Markers of insulin metabolismglycemic control (primary outcomes) and lipid profile (secondary outcomes) will be quantified at study baseline and end-of-trial.
پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای گلیسمیک کنترل (پیامدهای اولیه) و پروفایل لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
پيامدها: مارکرهای متابولیسم انسولینگلیسمیک کنترل (پیامدهای اولیه) و پروفایل لیپیدی (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
General information
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2017-12-21, 1396/09/30
2017-12-28, 1396/10/07
2017-12-2128 00:00:00
Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years.
Inclusion criteria: Patients with gestational diabetes
aged 18 to 40 years
Inclusion criteria: Patients with gestational diabetes; aged 18 to 40 years.
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری؛ در محدوده سنی 18 تا 40 سال
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری
در محدوده سنی 18 تا 40 سال
معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری؛ در محدوده سنی 18 تا 40 سال
Exclusion criteria: Unwillingness to cooperate.
Exclusion criteria: Taking magnesium and vitamin E supplements 3 months before the intervention
Insulin therapy required during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Exclusion criteria: Unwillingness to cooperate.Taking magnesium and vitamin E supplements 3 months before the intervention Insulin therapy required during the intervention Pre-eclampsia Eclampsia Hypo and hyperthyroidism Smokers
معیار خروج از مطالعه: عدم تمایل به همکاری.
معیار خروج از مطالعه: گرفتن مکمل های منیزیم و ویتامین E سه ماه قبل مداخله
نیاز به انسولین درمانی در طول مداخله
پری اکلامپسی
اکلامپسی
کم کاری و پرکاری تیروئید
سیگاری ها
معیار خروج از مطالعه: عدم تمایلگرفتن مکمل های منیزیم و ویتامین E سه ماه قبل مداخله نیاز به همکاری.انسولین درمانی در طول مداخله پری اکلامپسی اکلامپسی کم کاری و پرکاری تیروئید سیگاری ها
Randomization will be done by the use of computer-generated random numbers.
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, 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-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، 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، 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 جدول اعداد تصادفی ایجاد شده توسط کامپیوترنرم افزار کامپیوتری انجام خواهد شد.
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 magnesium and vitamin E supplementation on metabolic profiles 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 magnesium supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes 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 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. Exclusion criteria: Taking magnesium and vitamin E supplements 3 months before the intervention, insulin therapy required during the intervention, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers.
Intervention groups
Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, 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 (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N24
Registration date:2017-12-24, 1396/10/03
Registration timing:registered_while_recruiting
Last update:2019-09-15, 1398/06/24
Update count:1
Registration date
2017-12-24, 1396/10/03
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
2017-12-04, 1396/09/13
Expected recruitment end date
2017-12-28, 1396/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in women with gestational diabetes mellitus
Public title
Effect of combined magnesium and vitamin E supplementation in treatment of women with gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes
aged 18 to 40 years
Exclusion criteria:
Exclusion criteria: Taking magnesium and vitamin E supplements 3 months before the intervention
Insulin therapy required during the intervention
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
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
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
3848176941
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.ARAKMU.REC.1396.215
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
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
LDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
FPG
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, 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
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Email
mjamilian@arakmu.ac.ir
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
3848176941
Phone
+98 86 3417 3645
Email
arjomandzadegan@arakmu.ac.ir
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
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