Effect of fish oil supplement on chronic atrial fibrillation

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2012110411362N1
• Date of registration: 2012-12-03
• Prospective Registration: No
• Primary sponsor: School of Public Health, Tehran University of Medical Sciences
• Public title: Effect of fish oil supplement on chronic atrial fibrillation
• Scientific title: Assessment of serum levels of adiponectin and asymmetric dimethylarginine in patients with persistent and permanent atrial fibrillation following supplementation with fish oil
• Date of first enrolment: 2012-04-20
• Target sample size: 80
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/11630
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Elnaz Khorrami
• Affiliation: Department of Nutrition and Biochemistry, School of Public Health

• Name: Elnaz Khorrami
• Affiliation: Department of Nutrition and Biochemistry

Key inclusion & exclusion criteria

Inclusion 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
Exclusion criteria:

Age minimum: 50 years
Age maximum: 81 years
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial fibrillation.
Atrial fibrillation and flutter

Atrial fibrillation and flutter

Intervention(s)

Intervention 1: intervention group: fish oil supplement, 2000mg for 8 weeks after a meal. Intervention 2: control group: olive oil placebo, 2000mg for 8 weeks after a meal.

Prevention

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

Placebo

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

Primary Outcome(s)

Adiponectin. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: µg/ml, elisa kit.

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

Secondary Outcome(s)

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

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

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

Triglyceride. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: mg/dl, enzymatic.

Total cholesterol. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: mg/dl, enzymatic.

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

Fasting blood sugar. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: mg/dl, enzymatic.

Waist circumference. Timepoint: waist Circumference. Method of measurement: meter tape, cm.

Weight. Timepoint: before ivtervention and 8 weeks afte rintervention. Method of measurement: Seca scale, kg.

Source(s) of Monetary Support

School of Public Health, Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Tehran University of Medical Sciences