Protocol summary

Summary
The present research is a randomized clinical trial for Determinant of the effects of fish oil supplementation on the adiponectin and ADMA serum levels in patients with chronic atrial fibrillation. The samples of the study will constitute 80 patients with chronic atrial fibrillation including men and women above 50 years with BMI higher than 25 kg/m2 coming to the Shahid Rajaei Heart Center. Exclusion criteria included the following: 1) suffering from hyperthyroidism, 2) disorders of heart valves, and 3) people who started taking in fish oil supplement within the three months to the intervention. Patients will be randomly divided into two groups. At the first meeting the purpose of study will be described and asked them to fill the consent form. Group 1 will receive 2000 mg fish oil capsules for eight weeks and group 2 will receive 2000mg placebo capsules (same shape, colour, size) two times after meal (each time 1capsule including 1000mg . The intake of nutrients will assess through 24-hour questionnaire filled in by the patients before and after treatment. Height, weight and waist circumference, will measure before and after the treatment. Furthermore, fasting blood will be collected and stored at -80 (c) refrigerator before and after the intervention. The serum levels of adiponectin, Asymmetric dimethylarginine, total cholesterol, low density lipoprotein, high density lipoprotein, very low density lipoprotein, triglyceride and fasting blood sugar will measure before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110411362N1
Registration date: 2012-12-03, 1391/09/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Elnaz Khorrami
Name of organization / entity
Public Health Depatment of Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 8391
Email address
el-khorami@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univesity of Medical Sciences School of Public Health and Institute of Public Health Rechearches
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of serum levels of adiponectin and asymmetric dimethylarginine in patients with persistent and permanent atrial fibrillation following supplementation with fish oil
Public title
Effect of fish oil supplement on chronic atrial fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: postmenopausal women; men; above 50 years old; BMI higher than 25 kg/m2; patients without hyperthyroidism; patients without heart valve disorders; patients did not underwent coronary artery bypass surgery in the last three months; patients without heart failure of class IV; patients without history of alcohol abuse; not started taking in fish oil supplement within the three months before intervention; patients without allergy to fish oil Exclusion criteria: patients who stops taking supplement or placebo; patients who lose interest in participating in the study; patient who undergo coronary bypass
Age
From 50 years old to 81 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Tehran University of Medical Sciences
Street address
Poursina st, 16 Azar st, Keshavarz blv
City
Tehran
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
130/382

Health conditions studied

1

Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
adiponectin
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
µg/ml, elisa kit

2

Description
Asymmetric dimethylarginine (ADMA)
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mol/Lµ, elisa kit

Secondary outcomes

1

Description
HDL
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, enzymatic

2

Description
LDL
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, enzymatic

3

Description
total cholesterol
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, enzymatic

4

Description
VLDL
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, Friedewald-Formel

5

Description
triglyceride
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, enzymatic

6

Description
fasting blood sugar
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
mg/dl, enzymatic

7

Description
weight
Timepoint
before ivtervention and 8 weeks afte rintervention
Method of measurement
Seca scale, kg

8

Description
bady mass index (BMI
Timepoint
before ivtervention and 8 weeks afte rintervention
Method of measurement
calculation, kg/cm2

9

Description
waist circumference
Timepoint
waist Circumference
Method of measurement
meter tape, cm

Intervention groups

1

Description
intervention group: fish oil supplement, 2000mg for 8 weeks after a meal
Category
Prevention

2

Description
control group: olive oil placebo, 2000mg for 8 weeks after a meal
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Heart Center
Full name of responsible person
Elnaz Khorrami
Street address
beside Melat park, Valiasr st
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Hosseinzadeh
Street address
Ghods st, Poursina st, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Public Health, 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
Department of Nutrition and Biochemistry
Full name of responsible person
Elnaz Khorrami
Position
Master of Nutritional Science
Other areas of specialty/work
Street address
Department of Nutrition and Biochemistry,School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
el-khorami@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition and Biochemistry, School of Public Health
Full name of responsible person
Elnaz Khorrami
Position
Master of Nutritional Science
Other areas of specialty/work
Street address
Department of Nutrition and Biochemistry,School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
el-khorami@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Nutrition and Biochemistry,School of Public Health, Tehran University of Medical Scien
Full name of responsible person
Elnaz khorrami
Position
Msc Nutrition
Other areas of specialty/work
Street address
36, Niloofar st, Yas st, Aghaghia blv, Azimie, Karaj
City
Tehran
Postal code
Phone
+98 26 3250 8391
Fax
Email
el-khorami@razi.tums.ac.ire_khorami22@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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