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Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA.
Eur J Clin Nutr. 2003 Oct; 57(10):1323-30.EJ

Abstract

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.

Authors+Show Affiliations

Wageningen Centre for Food Sciences (WCFS), Wageningen, The Netherlands. Ingeborg.Brouwer@staff.NutEpi.wau.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14506496

Citation

Brouwer, I A., et al. "Rationale and Design of a Randomised Controlled Clinical Trial On Supplemental Intake of N-3 Fatty Acids and Incidence of Cardiac Arrhythmia: SOFA." European Journal of Clinical Nutrition, vol. 57, no. 10, 2003, pp. 1323-30.
Brouwer IA, Zock PL, Wever EF, et al. Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. Eur J Clin Nutr. 2003;57(10):1323-30.
Brouwer, I. A., Zock, P. L., Wever, E. F., Hauer, R. N., Camm, A. J., Böcker, D., Otto-Terlouw, P., Katan, M. B., & Schouten, E. G. (2003). Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. European Journal of Clinical Nutrition, 57(10), 1323-30.
Brouwer IA, et al. Rationale and Design of a Randomised Controlled Clinical Trial On Supplemental Intake of N-3 Fatty Acids and Incidence of Cardiac Arrhythmia: SOFA. Eur J Clin Nutr. 2003;57(10):1323-30. PubMed PMID: 14506496.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rationale and design of a randomised controlled clinical trial on supplemental intake of n-3 fatty acids and incidence of cardiac arrhythmia: SOFA. AU - Brouwer,I A, AU - Zock,P L, AU - Wever,E F D, AU - Hauer,R N W, AU - Camm,A J, AU - Böcker,D, AU - Otto-Terlouw,P, AU - Katan,M B, AU - Schouten,E G, PY - 2003/9/25/pubmed PY - 2004/3/9/medline PY - 2003/9/25/entrez SP - 1323 EP - 30 JF - European journal of clinical nutrition JO - Eur J Clin Nutr VL - 57 IS - 10 N2 - 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. SN - 0954-3007 UR - https://www.unboundmedicine.com/medline/citation/14506496/Rationale_and_design_of_a_randomised_controlled_clinical_trial_on_supplemental_intake_of_n_3_fatty_acids_and_incidence_of_cardiac_arrhythmia:_SOFA_ L2 - http://dx.doi.org/10.1038/sj.ejcn.1601695 DB - PRIME DP - Unbound Medicine ER -