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deleted old contents,contents that are not changed.
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General information
1
1
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The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
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پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Secondary outcomes
#1
HbA1c
Beck Depression Inventory
HbA1cBeck Depression Inventory
هموگلوبین گلیکوزیله
پرسشنامه افسردگی بک
هموگلوبین گلیکوزیلهپرسشنامه افسردگی بک
Laboratory clinical kit
Questionnaire
Laboratory clinical kitQuestionnaire
کیت آزمایشگاهی بالینی
پرسشنامه
کیت آزمایشگاهی بالینیپرسشنامه
#2
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Beck Anxiety Inventory
Beck Anxiety Inventory
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پرسشنامه اضطراب بک
پرسشنامه اضطراب بک
empty
Baseline and End-of-trial
Baseline and End-of-trial
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ابتدا و انتهای مداخله
ابتدا و انتهای مداخله
empty
Questionnaire
Questionnaire
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پرسشنامه
پرسشنامه
Recruitment centers
#1
Name of recruitment center - English: Beheshti hospital in kashan
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr Alireza Farrokhian
Full name of responsible person - Persian: دکتر علیرضا فرخیان
Street address - English: Shahid Beheshti Hospital, Pezeshk Ave., Qotb-e-Ravandi Blvd
Street address - Persian: بلوار قطب راوندی، خیابان پزشک، بیمارستان شهید بهشتی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 0026
Fax:
Email: farrokhian.ar@gmail.com
Web page address:
Name of recruitment center - English: Beheshti hospital in kashan
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr Alireza Farrokhian
Full name of responsible person - Persian: دکتر علیرضا فرخیان
Street address - English: Shahid Beheshti Hospital, Pezeshk Ave., Qotb-e-Ravandi Blvd
Street address - Persian: بلوار قطب راوندی، خیابان پزشک، بیمارستان شهید بهشتی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 0026
Fax:
Email: Farrokhian.ar@gmail.com
Web page address:
Name of recruitment center - English: Beheshti hospital in kashan Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان Full name of responsible person - English: Dr Alireza Farrokhian Full name of responsible person - Persian: دکتر علیرضا فرخیان Street address - English: Shahid Beheshti Hospital, Pezeshk Ave., Qotb-e-Ravandi Blvd Street address - Persian: بلوار قطب راوندی، خیابان پزشک، بیمارستان شهید بهشتی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5554 0026 Fax: Email: farrokhian.arFarrokhian.ar@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafshe
Full name of responsible person - Persian: حمیدرضا بنفشه
Street address - English: Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Street address - Persian: بلوار قطب راوندی، خیابان پزشک، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 0021
Fax:
Email: research@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafshe
Full name of responsible person - Persian: حمیدرضا بنفشه
Street address - English: Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Street address - Persian: بلوار قطب راوندی، خیابان پزشک، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 0021
Fax:
Email: Research@kaums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamid Reza Banafshe Full name of responsible person - Persian: حمیدرضا بنفشه Street address - English: Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd. Street address - Persian: بلوار قطب راوندی، خیابان پزشک، دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 0021 Fax: Email: researchResearch@kaums.ac.ir Web page address:
Sharing plan
yes
undecided
yesundecided
no
undecided
noundecided
no
undecided
noundecided
no
undecided
noundecided
yes
undecided
yesundecided
na
undecided
naundecided
na
undecided
naundecided
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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
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هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.
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A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.
بخشی از داده های مربوط به متغیرهای جمعیتی، تن سنجی و غذایی که در ابتدای مطالعه به دست آمده است و اطلاعات مربوط به پیامد اصلی به اشتراک گذاشته خواهد شد.
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بخشی از داده های مربوط به متغیرهای جمعیتی، تن سنجی و غذایی که در ابتدای مطالعه به دست آمده است و اطلاعات مربوط به پیامد اصلی به اشتراک گذاشته خواهد شد.
The start of the data access period will be one year after the publication of the results
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The start of the data access period will be one year after the publication of the results
شروع دوره دسترسی یک سال پس از چاپ نتایج
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شروع دوره دسترسی یک سال پس از چاپ نتایج
Researchers working in academic institutions
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Researchers working in academic institutions
محققین شاغل در موسسات دانشگاهی
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محققین شاغل در موسسات دانشگاهی
In order to conduct meta analysis studies
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In order to conduct meta analysis studies
به منظور انجام مطالعات متا آنالیز
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به منظور انجام مطالعات متا آنالیز
Mohsen Taghizadeh, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608
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Mohsen Taghizadeh, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608
محسن تقی زاده، ایران، کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی، گروه آموزشی تغذیه کد پستی: 88715973474 پست الکترونیک: sharifi-na@kaums.ac.ir تلفن : 00983155540021 فاکس: 00983155620608
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محسن تقی زاده، ایران، کاشان، بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان، دانشکده پزشکی، گروه آموزشی تغذیه کد پستی: 88715973474 پست الکترونیک: sharifi-na@kaums.ac.ir تلفن : 00983155540021 فاکس: 00983155620608
An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request
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An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request
متقاضی می تواند به وسیله ی پست الکترونیک درخواست خود را ارسال کند. پس از بررسی درخواست، فایل داده پس از حدود سه هفته از زمان ارسال درخواست برای ایشان فرستاده می شود.
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متقاضی می تواند به وسیله ی پست الکترونیک درخواست خود را ارسال کند. پس از بررسی درخواست، فایل داده پس از حدود سه هفته از زمان ارسال درخواست برای ایشان فرستاده می شود.
Protocol summary
Study aim
The aim of this study is to determine the effects of magnesium and zinc co-supplementation on metabolic profiles; inflammatory factor and biomarkers of oxidative stress in patients with coronary heart disease and type 2 diabetes mellitus .
Design
randomized double blind , controlled with placebo and drug , parallel clinical trial on 60 patients.randomization will be done based on Stratified randomization using statistical software.
Settings and conduct
Patients with coronary artery disease and type 2 diabetes have been evaluated for inclusion criteria in the heart clinic of Kashan University of Medical Sciences affiliated to the University of Medical Sciences. Anthropometric indices; nutritional variables; metabolic profiles; inflammatory factors; and oxidative stress biomarkers are measured at the beginning of the study and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 95-40 years and Exclusion Criteria: thyroid disease;No change in levels of LDL patients six weeks after the intervention; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney and liver failure; Unwillingness to cooperate; Antibiotic use during study.
Intervention groups
People at the beginning of the study will be placed in one of the two groups receiving supplementation of magnesium and zinc and the placebo group (containing starch) once a day for 3 months.
Main outcome variables
The primary outcome is insulin resistance and the secondary consequences of changes in the metabolic profile; inflammatory factors and oxidative stress biomarkers.
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N31
Registration date:2019-05-11, 1398/02/21
Registration timing:retrospective
Last update:2020-05-27, 1399/03/07
Update count:1
Registration date
2019-05-11, 1398/02/21
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of magnesium and zinc co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
Public title
The effect of magnesium and zinc co-supplementation in patients with coronary heart disease and type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 40 to 95 years;No smoking
Exclusion criteria:
thyroid disease;No change in levels of LDL patients six weeks after the intervention;Infection; Consumption of any type of supplement (vitamin, mineral, etc.) by the patient in the last 3 months; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney failure; Significant liver failure; Unwillingness to cooperate; Antibiotic use during study
Age
From 40 years old to 95 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is that the patients are placed on separate classes according to two criteria: BMI (BMI <25 BMI≥25) and age (<65 and 65≤), and then randomly in one of two groups receiving magnesium and zinc supplements and the placebo group (containing starch) are included. The study is done using the Stat Trek software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo after coding by the researcher are placed under supervision of clinical caregiver and then clinical caregiver provided them to the participants. Both clinical caregiver and participants are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.079
Health conditions studied
1
Description of health condition studied
coronary heart disease and type 2 diabetes mellitus
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
HOMA-Index
Timepoint
Baseline and End-of-trial
Method of measurement
Formula calculation
Secondary outcomes
1
Description
Fasting plasma glucose
Timepoint
Fasting plasma glucose
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-tria
Method of measurement
Elisa
3
Description
QUICKI
Timepoint
Baseline and End-of-tria
Method of measurement
Formula calculation
4
Description
Beck Depression Inventory
Timepoint
Baseline and End-of-tria
Method of measurement
Questionnaire
5
Description
Nitric oxide (NO)
Timepoint
Baseline and End-of-tria
Method of measurement
Spectrophotometry
6
Description
High sensitivity C-reactive protein (hs-CRP)
Timepoint
Baseline and End-of-tria
Method of measurement
Elisa
7
Description
Total Antioxidant Capacity (TAC)
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
8
Description
Total glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
9
Description
Malondialdehyde(MDA)
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
10
Description
Serum Total cholestrol
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
11
Description
Serum LDL-C
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
12
Description
HDL-C سرم
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
13
Description
Serum Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
14
Description
Beck Anxiety Inventory
Timepoint
Baseline and End-of-trial
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: a capsule containing150 mg zinc sulfate and 250 mg magnesium oxide once a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: 1000 mg Placebo capsule containing corn starch Once a day for 3 months