Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
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Protocol summary
Effect of oral MgSO4 administration on lipid profile, LOX1 and OX-LDL in patients with atherosclerosis plaque
Effect of MgSo4 on atherosclerosis
Effect of oral MgSO4 administrationMgSo4 on lipid profile, LOX1 and OX-LDL in patients with atherosclerosis plaque
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
تاثیر سولفات منیزیم بر آترواسکلروز
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
Lipid profile, plasma oxLDL level and LOX1 gene expression.
Lipid profile, plasma oxLDL level and LOX1 gene . plasma
inflammation marker and its gene expression, anti oxidant capacity, and plasma lysyl peroxidase level.
Lipid profile, plasma oxLDL level and LOX1 gene . plasma inflammation marker and its gene expression, anti oxidant capacity, and plasma lysyl peroxidase level.
پروفایل چربی، سطح پلاسمایی oxLDL و بیان ژن LOX1
پروفایل چربی، سطح پلاسمایی oxLDL و بیان ژن LOX1، ظرفیت آنتی اکسیدانی تام خون، سطح پلاسمایی و بیان ژن فاکتورهای التهابی، سطح سرمی لایزیل پراکسیداز
پروفایل چربی، سطح پلاسمایی oxLDL و بیان ژن LOX1، ظرفیت آنتی اکسیدانی تام خون، سطح پلاسمایی و بیان ژن فاکتورهای التهابی، سطح سرمی لایزیل پراکسیداز
General information
Effect of oral MgSo4 administration on plasma ox-LDL, LOX-1 and lipid profiles in atherosclerosis patients
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای التهابی، ظرفیت آنتی اکسیدانی، لایزین پراکسیداز، LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای التهابی، ظرفیت آنتی اکسیدانی، لایزین پراکسیداز، LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
Effect of oral MgSo4 administration on plasma ox-LDL, LOX-1 and lipid profiles in atherosclerosis patients
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای التهابی، ظرفیت آنتی اکسیدانی، لایزین پراکسیداز، LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
بررسی تاثیر سولفات منیزیم خوراکی بر سطح مارکرهای التهابی، ظرفیت آنتی اکسیدانی، لایزین پراکسیداز، LOX-1 ،ox-LDL و پروفایل های چربی در بیماران دارای پلاک های آترواسکلروز
Protocol summary
Study aim
Effect of MgSo4 on atherosclerosis
Design
This study is a double blind clinical trial which will be done on 100 patients. The participants will be divided into the two groups, Mg-treated group (300 mg MgSo4 daily) and control group (received placebo). The patients and personnel are blind to group assignment. Only the study analyst see unblinded data, but is not in contact with the participants.
Settings and conduct
This study will be done in Angiography department in Shahid Mohammadi hospital in Bandar Abbas. The patients and personnel will be blind to group assignment. Only the study analyst see unblinded data, but is not in contact with the participants.
Participants/Inclusion and exclusion criteria
The inclusion criteria:
1- Patients above 55 for women and 45 for men with moderate CAD
The exclusion criteria:
1- Women under age 55, patients received Mg and Ca supplements, patients with left main lesion
2- patient with cancer or allergy, inflammation, patient with history of drug allergy, patient received immunosuppressive medications
3- Patients who had known kidney diseases and their serum creatinin above 1.5 mg/dl , raised hepatic enzymes above 3 folds over normal range, alcoholic patients, pregnant
4. Patients with current MI or CVA and patient with hypothyroidism or hyperthyroidism
Intervention groups
Patients with moderate CAD with atherosclerotic plaque less than 69% who are not candidate for angioplasty will be selected and will be divided into the two groups. Then blood and urine samples will be taken in order to determine the indexes every three months. Systolic and diastolic blood pressure, heart rate, weight, height, waist and hip circumference also will be measured every three months.
Main outcome variables
Lipid profile, plasma oxLDL level and LOX1 gene . plasma
inflammation marker and its gene expression, anti oxidant capacity, and plasma lysyl peroxidase level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151028024756N3
Registration date:2018-07-28, 1397/05/06
Registration timing:registered_while_recruiting
Last update:2019-06-30, 1398/04/09
Update count:2
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Nepton Soltani
Name of organization / entity
Hormozgan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 913 325 1067
Email address
nsoltani@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
Public title
Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, ox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Moderate coronary artery disease<60 -2. Age of women and men should be more than 55 years and 45 years respectively. 3.Also people that are diabetic, hypertension, hyperlipidemia , smoker and insulin resistance will be entered in the study.
Exclusion criteria:
1.Age of women be less than 55 years,2. pregnant women3. patients who are using magnesium and calcium containing supplements 4. patients who have experienced renal insufficiency (serum creatinine levels more than 1.3 mg/dl in women and more than 1.5 mg/dl in men). 5- elevated hepatic enzymes (more than 3 folds over normal values),recent infections (less than one month prior to study) and chronic inflammatory diseases, cerebrovascular accident(CVA), also cancer and drug sensetivity
Age
From 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Only one of the researchers who are not involved in data analyzing and not related to the patient treatment is responsible for dividing patients between the two groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hormozgan University of Medical Sciences
Street address
Emam Hossein Blv. Faculty of Medicineو Hormozgan University of Medical Science
City
bandar abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2018-11-23, 1397/09/02
Ethics committee reference number
IR.HUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied
Patients with high blood pressure and Hyperlipidemic with a small plaque in one of the coronary arteries
ICD-10 code
I25.10
ICD-10 code description
Atherosclerotic heart disease of native coronary artery without angina pectoris
Primary outcomes
1
Description
Hypertension- Hyperlipidemic- Atherosclerosis
Timepoint
every three months
Method of measurement
Barometer device and appropriate kits
Secondary outcomes
1
Description
Size of Atherosclerosis plaque
Timepoint
After one year
Method of measurement
With Angiography if patient satisfies
Intervention groups
1
Description
Patients with CAD (moderate coronary artery disease) under 60% who will chose for intervention group after angiography. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected from the patients. The weight, blood pressure,waist and hip circumference of the patient are checked and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression. . Along with their routine treatment they will receive 300 mg/ day of oral magnesium sulfate from Neyak Company, which is taken with food for one year and they will follow up every three months. Blood samples are taken at each visit from the patient to measure the variables, the patient's weight, blood pressure, waist and hip circumference are also checked.
Category
Treatment - Drugs
2
Description
Control group: Patients with CAD under 60% who also will chose after angiography for control group. For all patients, the demographic information, the records of the disease and the medications they use are filled and collected and blood sample will be taken to measure lipid profile, plasma oxLDL level and LOX1 gene expression . This group will receive placebo which is made by Neyak Corporation with the same shape as intervention group. These patients are also followed up once every three months for a period of one year. In each visit, blood sample will be taken to measure study's variables and blood pressure, weight, waist and hip circumference of the patient will be checked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr Hossain Farshidi
Street address
Islamic republic blv
City
Bandar Abbas
Province
Hormozgan
Postal code
123456789
Phone
+98 76 3333 7192
Email
solnep2002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nepton Soltani
Street address
Hezar Jareeb St
City
Isfahan
Province
Isfehan
Postal code
987654321
Phone
+98 31 3792 9019
Email
solnep2002@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
60
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
Esfahan University of Medical Sciences
Full name of responsible person
Nepton Soltani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hezar Gerib
City
Isfahan
Province
Isfehan
Postal code
987654321
Phone
+98 31 3792 8019
Email
solnep2002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nepton Soltani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
987654321
Phone
+98 31 3792 8019
Email
solnep2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nepton Soltani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
987654321
Phone
+98 31 3792 9019
Email
solnep2002@yahoo.com
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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available