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

Alejandro López-Neyra*, Lucrecia Suárez, Marta Muñoz, Ana de Blas, Marta Ruiz de Valbuena, María Garriga, Joaquim Calvo, Carmen Ribes, Rosa Girón Moreno, Luis Máiz, David González, Carlos Bousoño, Javier Manzanares, Óscar Pastor, Javier Martínez-Botas, Rosa del Campo, Rafael Cantón, Garbiñe Roy, Miriam Menacho, David ArroyoJavier Zamora, Joan B. Soriano, Adelaida Lamas

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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)

Original languageEnglish
Article number102186
JournalProstaglandins Leukotrienes and Essential Fatty Acids
Volume162
DOIs
Publication statusPublished - Nov 2020

Bibliographical note

Funding Information:
This study was funded by:

Funding Information:
e. “Ayuda a la Fibrosis Quística” grant, awarded by Pablo Motos Foundation 2011.

Funding Information:
This study has been supported by the Spanish Clinical Research Network (SCReN), funded by the Instituto de Salud Carlos III, Subdirección General de Evaluación y Fomento de la Investigación, grant PT13/0002/0007 integrated in the Plan Estatal de I+D+I 2013-2016, and cofinanced by the European Regional Development Fund.

Publisher Copyright:
© 2020 Elsevier Ltd

Keywords

  • Cystic Fibrosis
  • Docosahexaenoic acid
  • Essential fatty acids
  • Inflammation
  • Interleukin-8
  • Omega-3 Fatty Acids

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Cell Biology

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