Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial

Prostaglandins Leukot Essent Fatty Acids. 2020 Nov:162:102186. doi: 10.1016/j.plefa.2020.102186. Epub 2020 Oct 1.

Abstract

Background: Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation.

Methods: This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV1, pulmonary exacerbations, antibiotic use, nutritional status and quality of life).

Results: Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups.

Conclusion: In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).

Keywords: Cystic Fibrosis; Docosahexaenoic acid; Essential fatty acids; Inflammation; Interleukin-8; Omega-3 Fatty Acids.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Biomarkers / metabolism
  • Child
  • Child, Preschool
  • Cystic Fibrosis* / drug therapy
  • Cystic Fibrosis* / metabolism
  • Cytokines / blood*
  • Docosahexaenoic Acids / administration & dosage*
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Lactic Acid / blood*
  • Leukocyte Elastase / blood*
  • Leukocyte L1 Antigen Complex / metabolism*
  • Male
  • Time Factors

Substances

  • Biomarkers
  • Cytokines
  • Leukocyte L1 Antigen Complex
  • Docosahexaenoic Acids
  • Lactic Acid
  • ELANE protein, human
  • Leukocyte Elastase

Associated data

  • ClinicalTrials.gov/NCT01783613