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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

European Journal of Clinical Nutrition volume 57, pages 1323–1330 (2003)Cite this article

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.

Sponsorship: Wageningen Centre for Food Sciences. Wageningen Centre for Food Sciences is an alliance of major Dutch food industries, TNO nutrition and Food Research, Zeist, the Netherlands, and Wageningen University and Research Centre, Wageningen, the Netherlands, with financial support by the Dutch Government.

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Acknowledgements

We thank the research nurses Francine van Vliet and Rens Doornbos for their valuable contribution to the pilot study.

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Authors and Affiliations

  1. Wageningen Centre for Food Sciences (WCFS), Wageningen, The Netherlands

    I A Brouwer, P L Zock, M B Katan & E G Schouten

  2. Division of Human Nutrition and Epidemiology, Wageningen University, The Netherlands

    I A Brouwer, P L Zock, M B Katan & E G Schouten

  3. Department of Cardiology, St Antonius Hospital, HLCU, Nieuwegein, The Netherlands

    E F D Wever

  4. Department of Cardiology, University Medical Centre Utrecht, HLCU, The Netherlands

    R N W Hauer

  5. Department of Cardiological Sciences, St George Hospital/Medical School, London, UK

    A J Camm

  6. Department of Cardiology, University Hospital Münster, Germany

    D Böcker

  7. Cardialysis BV, Rotterdam, The Netherlands

    P Otto-Terlouw

Authors
  1. I A Brouwer
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  2. P L Zock
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  3. E F D Wever
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  4. R N W Hauer
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  5. A J Camm
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  6. D Böcker
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  7. P Otto-Terlouw
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  8. M B Katan
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  9. E G Schouten
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Contributions

Contributors: All authors contributed to the development of the protocol and were involved in the writing of the manuscript. Dr Brouwer coordinates SOFA and wrote the manuscript.

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Correspondence to I A Brouwer.

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Brouwer, I., Zock, P., Wever, E. 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 57, 1323–1330 (2003). https://doi.org/10.1038/sj.ejcn.1601695

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  • DOI: https://doi.org/10.1038/sj.ejcn.1601695

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