Protocol summary
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Study aim
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Effect of MgSo4 on atherosclerosis
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Add more related indexes to atherosclerosis
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151028024756N3
Registration date:
2018-07-28, 1397/05/06
Registration timing:
registered_while_recruiting
Last update:
2019-12-16, 1398/09/25
Update count:
2
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Registration date
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2018-07-28, 1397/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-22, 1397/03/01
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Expected recruitment end date
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2019-05-22, 1398/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of oral MgSo4 administration on plasma, inflammation marker, anti oxidant capacity, lysyl peroxidase, SIRT1, p53, eNOSox-LDL, LOX-1 levels and lipid profiles in atherosclerosis patients
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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on random numbers
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-23, 1397/09/02
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Ethics committee reference number
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IR.HUMS.REC.1397.019
Health conditions studied
1
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Description of health condition studied
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Patients with high blood pressure and Hyperlipidemic with a small plaque in one of the coronary arteries
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ICD-10 code
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I25.10
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery without angina pectoris
Primary outcomes
1
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Description
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Hypertension- Hyperlipidemic- Atherosclerosis
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Timepoint
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every three months
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Method of measurement
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Barometer device and appropriate kits
Secondary outcomes
1
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Description
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Size of Atherosclerosis plaque
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Timepoint
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After one year
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Method of measurement
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With Angiography if patient satisfies
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bandare-abbas University of Medical Sciences
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Proportion provided by this source
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60
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available