Feasibility of ω-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Fulton, Ashley S. and Hill, Alison M. and Williams, Marie T. and Howe, Peter R. C. and Frith, Peter A. and Wood, Lisa G. and Garg, Manohar L. and Coates, Alison M. (2013) Feasibility of ω-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials, 14 (107).

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Abstract

BACKGROUND: There is evidence to support the use of supplementation with long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) from oily fish or fish oil for the treatment of various inflammatory diseases such as rheumatoid arthritis. Chronic obstructive pulmonary disease (COPD) is a progressive, terminal disease characterized by persistent airflow limitation, lung and systemic inflammation. To date, one randomized controlled trial has been published that assessed the efficacy of LCn-3PUFA in people with this condition. The aim of this article is to discuss the feasibility of conducting a trial to evaluate fish oil supplementation as adjunct therapy in people with COPD. METHODS/DESIGN: A 16-week parallel, double-blind, randomized, placebo-controlled dietary supplementation trial will be evaluated. Forty participants meeting spirometric and clinical criteria for COPD will be recruited from metropolitan Adelaide, South Australia. Participants will be randomized by minimization, based on a score derived from the modified Medical Research Council Scale for breathlessness, to receive 6 g/day of fish oil (approximately 3.6 g/day of LCn-3PUFA), or placebo (6 g/day of corn oil) capsules. Feasibility outcomes (recruitment, retention, supplement adherence, and time lost to exacerbation) and scientific outcomes (effect size and estimates of variance for inflammatory biomarkers, incorporation of LCn-3PUFA into erythrocytes, small airways function, dyspnea and functional exercise capacity) will be assessed pre- and post-intervention. Key feasibility criteria include recruitment of 40 participants in 52 weeks, 75% participant retention rate, 2% increase in the proportion of long-chain omega-3 fatty acids in erythrocytes, and a positive moderate effect size in at least three efficacy measures. DISCUSSION: There are a number of challenges in designing supplementation intervention studies with this population. These include the lack of prior data from which to select appropriate primary outcomes or to estimate effect sizes, and the feasibility of continuous supplementation in a population characterized by multiple comorbidities and a high likelihood of exacerbations, potentially requiring hospitalization or change in medication. Upon completion of this protocol, feasibility outcomes will guide the direction of future multicentre dietary interventions in this population. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000158864.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: Published version made available under Open Access.
Faculty / Department / School: No Faculty
Date Deposited: 05 Jun 2017 05:06
Last Modified: 05 Jun 2017 07:03
Uncontrolled Keywords: Administration, Oral; Anti-Inflammatory Agents; Capsules; Clinical Protocols; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3; Feasibility Studies; Humans; Lung; Pulmonary Disease, Chronic Obstructive; Research Design; South Australia; Spirometry; Time Factors
Fields of Research : 11 Medical and Health Sciences > 1102 Cardiovascular Medicine and Haematology > 110299 Cardiovascular Medicine and Haematology not elsewhere classified
Socio-Economic Objective: E Expanding Knowledge > 97 Expanding Knowledge > 970111 Expanding Knowledge in the Medical and Health Sciences
Identification Number or DOI: 10.1186/1745-6215-14-107
URI: http://eprints.usq.edu.au/id/eprint/31591

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