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The effect of vitamin E and C supplements on risk factors of coronary artery disease (CAD) in patients with coronary heart disease

Protocol summary

Study aim
Determination of the effect of vitamin E and C supplements on risk factors of coronary artery disease (CAD) in patients with coronary heart disease
Design
In this clinical trial with a factorial design, the patients will be allocated to four groups of control, vitamin C, vitamin E and combination by permutation blocks. The groups will be matched in terms of confounding variables such as occupation, education, age, gender, diabetes, physical activity, drugs that affect blood lipids and glucose, blood lipids and glucose levels, blood pressure, BMI and CRP.
Settings and conduct
The research area will be the specialized heart clinic of Jawad Al-Aimeh and Razavi hospitals in Mashhad. After obtaining informed consent from patients, explaining the goals of the plan for them, if they have inclusion criteria, after 15 minutes of rest, the systolic and diastolic blood pressure of the patient and then the height and weight will be measured. Then everyone after 8-12 hours of fasting during the night and a blood sample to check FBS, lipid profile and CRP will be sent to the laboratory. After grouping the patients and implementation of the intervention, again, the outcome variables will be measured in all patients at the end of the study.
Participants/Inclusion and exclusion criteria
All patients who are willing to participate in the study have entry requirements in terms of inclusion criteria.
Intervention groups
In the control group, no supplement will be given and only routine care will be provided. In other groups, in addition to routine care, separately in group of vitamin C, 1,000 mg of vitamin C for 10 weeks, in vitamin E, 600 mg of vitamin E for 10 weeks, in combination, daily 1000 mg of vitamin C and 600 mg of vitamin E for 10 weeks will be prescribed by your doctor.
Main outcome variables
Systolic and diastolic blood pressure, lipid profiles, FBS, BMI and CRP

General information

Reason for update
Acronym
مطالعه بیماری های عروق کرونر
IRCT registration information
IRCT registration number: IRCT20180804040688N1
Registration date: 2018-08-15, 1397/05/24
Registration timing: prospective

Last update: 2018-08-15, 1397/05/24
Update count: 0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Sajad Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3366 4228
Email address
sajadrezaeistusurgical009@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin E and C supplements on risk factors of coronary artery disease (CAD) in patients with coronary heart disease
Public title
The effect of vitamin E and C on risk factors of coronary artery disease (CAD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in research Certification of physician to receive vitamins E and C Age 18 to 50 years old Acceptable listening, speaking and consciousness to answer the questions Waist circumference is more than 102 cm in men and more than 88 cm in women Fasting triglyceride equal to or greater than 150 mg/dl HDL less than 40 mg/dl Systolic blood pressure equal to or greater than 135 mm Hg Fasting glucose is greater than or equal to 110 mg/dl
Exclusion criteria:
Not pregnant Do Not taking corticosteroids and contraceptives Lack of underlying diseases (such as kidney and liver failure, thyroid dysfunction, malignancy, mental, autoimmune and infectious diseases) Lack of specific medical conditions requires as a change in diet and exercise program Lack of insulin treatment The need for surgery during the study Cancellation request of the patient Incidence of unwanted side effects Irregular consumption of supplements
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: permutation block Random unit: Individual Randomization Tool: Random Numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Research Deputy in Gonabad University of Medical Sciences, next to the Asian Road, Gonabad, Khorasan Razavi, Iran.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.GMU.REC.1397.064

Health conditions studied

1

Description of health condition studied
Coronary artery disease (CAD)
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
Before and after the intervention
Method of measurement
Mercury sphygmomanometer

2

Description
Lipid profiles
Timepoint
Before and after the intervention
Method of measurement
Laboratory instruments

3

Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Laboratory instruments

4

Description
Body mass index (BMI)
Timepoint
Before and after the intervention
Method of measurement
Weight (kilograms) / square height (meter)

5

Description
C-reactive protein (CRP)
Timepoint
Before and after the intervention
Method of measurement
Laboratory instruments

Secondary outcomes

empty

Intervention groups

1

Description
Vitamin E Group: This group only consumes vitamin E supplement of 600 mg daily for 10 weeks.
Category
Treatment - Drugs

2

Description
Vitamin C Group: This group only consumes vitamin C supplement of 1000 mg daily for 10 weeks.
Category
Treatment - Drugs

3

Description
Combination Group: This group consumes vitamin E of 600 mg and vitamin C of 1000 mg supplements daily for 10 weeks.
Category
Treatment - Drugs

4

Description
Control group: This group will not receive any supplement.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razavi hospital in Mashhad
Full name of responsible person
Sajjad Rezaei
Street address
Razavi Hospital, after Ghaem Bridge, Freedom Highway, Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9198613636
Phone
+98 51 3666 8888
Email
info@razavihospital.com

2

Recruitment center
Name of recruitment center
Jawad Al-Aimeh hospital in Mashhad
Full name of responsible person
Sajjad Rezaei
Street address
Jawad Al-Aimeh hospital, Honarestan three way, Vakil Abad boulevard, Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 3881 6010
Email
info@javadalaemehosp.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Research Deputy in Gonabad University of Medical Sciences, next to the Asian Road, Gonabad, Khorasan Razavi, Iran.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 3814
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Sajjad Rezaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Surgical thecnology
Street address
No. 4, 10 Golriz Ave., 10 sarakhs Ave., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9167911713
Phone
+98 51 3366 4228
Email
sajadrezaeistusurgical009@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Samane Najafi
Position
Lecturer, Faculty member, School of Nursing, Gonabad University of Medical Sciences.
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of nursing, Gonabad University of Medical Sciences, next to the Asian Road, Gonabad, Khorasan Razavi, Iran.
City
Gonabad
Province
Razavi Khorasan
Postal code
91673911713
Phone
+98 51 5722 5027
Fax
Email
s.najafi2012@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Sajjad Rezaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Surgical thecnology
Street address
No. 4, 10 Golriz Ave., 10 sarakhs Ave., Mashhad, Khorasan Razavi, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9167911713
Phone
+98 85 3366 4228
Email
sajadrezaeistusurgical009@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potential data will be shared after unidentifiable individuals.
When the data will become available and for how long
Get started 8 months after the publication of results
To whom data/document is available
The researcher on academic institutions
Under which criteria data/document could be used
The information should not be changed.
From where data/document is obtainable
E-mail Sajjad Rezaei: sajadrezaeistusurgical009@gmail.com E-mail Samane Najafi: s.najafi2012@yahoo.com
What processes are involved for a request to access data/document
The E-mail to the given address and provide sufficient and acceptable information. Information will be given if data is acceptable.
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