Document Detail

Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA.
MedLine Citation:
PMID:  14506496     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Evidence from earlier studies indicates that intake of very long-chain n-3 polyunsaturated fatty acids (n-3 PUFA, also named omega-3 fatty acids) as present in fish oil reduces the risk of sudden death. Sudden death forms a major part of mortality from cardiovascular disease and is in most cases a direct consequence of cardiac arrhythmia. n-3 PUFA may exert their protective effect through reducing the susceptibility for cardiac arrhythmia.
OBJECTIVE: To investigate the effect of n-3 PUFA on the incidence of recurrent ventricular arrhythmia. This paper presents the rationale, design and methods of the Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) and discusses problems encountered in conducting a multicentre clinical trial on food.
DESIGN: A randomised, parallel, placebo-controlled, double blind intervention study, which obeys the guidelines for Good Clinical Practice.
SETTING: Multiple cardiology centres in Europe.
SUBJECTS: A total of 500 patients with an implantable cardioverter defibrillator (ICD). An ICD detects, treats and stores cardiac arrhythmic events in its memory chip.
INTERVENTIONS: Patients receive either 2 g/day of fish oil, containing approximately 450 mg eicosapentaenoic acid and 350 mg docosahexaenoic acid, or placebo for 12 months.
PRIMARY OUTCOME: Spontaneous ventricular tachyarrhythmias as recorded by the ICD or all-cause mortality.
CONCLUSION: SOFA is designed to answer the question whether intake of n-3 PUFA from fish-a regular food ingredient-can reduce the incidence of life-threatening cardiac arrhythmia. If this proves to be true, increasing the intake of n-3 PUFA could be an easy, effective and safe measure to prevent fatal arrhythmia in the general population.
I A Brouwer; P L Zock; E F D Wever; R N W Hauer; A J Camm; D Böcker; P Otto-Terlouw; M B Katan; E G Schouten
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of clinical nutrition     Volume:  57     ISSN:  0954-3007     ISO Abbreviation:  Eur J Clin Nutr     Publication Date:  2003 Oct 
Date Detail:
Created Date:  2003-09-24     Completed Date:  2004-03-08     Revised Date:  2011-08-25    
Medline Journal Info:
Nlm Unique ID:  8804070     Medline TA:  Eur J Clin Nutr     Country:  England    
Other Details:
Languages:  eng     Pagination:  1323-30     Citation Subset:  IM    
Wageningen Centre for Food Sciences (WCFS), Wageningen, The Netherlands.
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MeSH Terms
Anti-Arrhythmia Agents / administration & dosage
Arrhythmias, Cardiac / epidemiology,  prevention & control*
Death, Sudden, Cardiac / prevention & control
Defibrillators, Implantable
Double-Blind Method
Fatty Acids, Omega-3 / administration & dosage*
Fish Oils
Multicenter Studies as Topic / methods
Patient Compliance
Pilot Projects
Quality Control
Randomized Controlled Trials as Topic / methods*,  standards
Research Design*
Sample Size
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 0/Fatty Acids, Omega-3; 0/Fish Oils

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