Protocol summary

Summary
The present study aimed to determine the effect of omega-3 fatty acids supplementation on serum nitric oxide levels in men with coronary artery disease. Design and Implementation:In this Clinical Trial Double Blind study,42 patients are selected from Tehran Heart center. Consent form, general questionnaire, 24-hour recall of food and international physical activity questionnaire were completed.Patient's blood pressure, anthropometric measurements, height, weight and fat mass of patients are measured. Then, in order to perform the test,10cc blood sample is taken.At the end, we give patients with omega-3 supplementation at a dose of 4 g / day or placebo (oral paraffin) at a dose of 4 g / day for two months. After 2 months,patient s physical activity, questionnaire were asked and weight,and blood pressure of the patient were measured. inclusion criteria for this study include heart disease, any other diseases, and do not use vitamin supplements or diets at least 4-6 weeks before the intervention. Exclusion criteria are an allergic reaction to Omega-3. In this randomized double blind study, 42 cardiac patients were selected based on inclusion and exclusion criteria. Patients were randomly assigned into two groups, including group 1- receiving omega-3 supplements and group 2-receiving placebo. The omega 3 treated group received 4 capsules of 1 g (4 g) of omega-3 daily and placebo group received 4 capsules of 1 g of oral paraffin for 3 months. Two capsules are taken along with lunch and two capsules are taken with dinner. Primary outcome variable: Determination of mean serum NO level before and after intervention in the omega-3 fatty acid supplement group compared to placebo group

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081335665N1
Registration date: 2017-11-06, 1396/08/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-06, 1396/08/15
Registrant information
Name
Mahnaz Zarei
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3057
Email address
m-zarei@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Grant 6 papers in one year. Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-10-12, 1392/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 fatty acid supplements on serum nitric oxide in cardiovascular men patients referred to the heart center of Tehran
Public title
Effect of omega-3 fatty acid supplementation on serum nitric oxide levels
Purpose
Prevention
Inclusion/Exclusion criteria
Cardiac patients, Lack of other diseases,Avoid dietary supplements, vitamins at least 4-6 weeks before and throughout the intervention, No diet, supplements or special activity. Exclusion criteria: A reaction to Omega compounds
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe Of Tehran University Of MedicalSciences
Street address
Pour Sina Street
City
Tehran
Postal code
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2578

Health conditions studied

1

Description of health condition studied
Atherosclerotic Heart Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Determination of mean serum NO level before and after intervention in the omega-3 fatty acid supplement group compared to placebo group
Timepoint
2Month
Method of measurement
Elisa

Secondary outcomes

1

Description
Body Mass Index (BMI)
Timepoint
Before and after 2 months of intervention
Method of measurement
Weight ratio to squared height

2

Description
weight
Timepoint
Before and after 2 months of intervention
Method of measurement
seca scale in kilograms

3

Description
Waist
Timepoint
Before and after 2 months of intervention
Method of measurement
Band meters in cm

Intervention groups

1

Description
First group intervention: receptor of omega-3 fatty acids, 4 g oral cups, twice a day with lunch, for 2 months
Category
Treatment - Drugs

2

Description
Placebo (oral paraffin) at a dose of 4 g per day for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Ebrahim Nematipour
Street address
North Karegar street, Tehran Heart Center
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Ms Javadi
Street address
Sixth Floor,Setad Department,Ghods Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Zarei
Position
Msc
Other areas of specialty/work
Street address
Poursina street
City
Tehran
Postal code
Phone
+98 21 4293 3057
Fax
Email
mahnazzareei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mahmoud Djalali
Position
PhD
Other areas of specialty/work
Street address
Poursina street
City
Tehran
Postal code
Phone
+98 21 4293 3057
Fax
Email
mjalali87@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Zarei
Position
Msc
Other areas of specialty/work
Street address
Poursina street
City
Tehran
Postal code
Phone
+98 21 4293 3057
Fax
Email
mahnazzareei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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