title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000158864.
authors.affiliation: Nutritional Physiology Research Centre, Sansom Institute for Health Research, School of Health Sciences, University of South Australia, City East Campus, Frome Road, Adelaide, South Australia 5000, Australia.
authors.forename: Ashley S
authors.initials: AS
authors.lastname: Fulton
authors.forename: Alison M
authors.initials: AM
authors.lastname: Hill
authors.forename: Marie T
authors.initials: MT
authors.lastname: Williams
authors.forename: Peter R C
authors.initials: PR
authors.lastname: Howe
authors.forename: Peter A
authors.initials: PA
authors.lastname: Frith
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Wood
authors.forename: Manohar L
authors.initials: ML
authors.lastname: Garg
authors.forename: Alison M
authors.initials: AM
authors.lastname: Coates
mesh_terms: D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D002985:Clinical Protocols; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005240:Feasibility Studies; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012107:Research Design; D013021:South Australia; D013147:Spirometry; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D002214:Capsules; D015525:Fatty Acids, Omega-3