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

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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • López-Neyra A.
  • Suárez L.
  • Muñoz M.
  • de Blas A.
  • Ruiz de Valbuena M.
  • Garriga M.
  • Girón Moreno R.
  • Máiz L.
  • González D.
  • Bousoño C.
  • Manzanares J.
  • Pastor Ó.
  • Martínez-Botas J.
  • del Campo R.
  • Cantón R.
  • Roy G.
  • Menacho M.
  • Arroyo D.
  • Zamora J.
  • Soriano J.B.
  • Lamas A.

Grupos

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-1ß, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1ß, 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) © 2020 Elsevier Ltd

Datos de la publicación

ISSN/ISSNe:
0952-3278, 1532-2823

PROSTAGLANDINS LEUKOTRIENES AND ESSENTIAL FATTY ACIDS  ELSEVIER SCI LTD

Tipo:
Article
Páginas:
-
PubMed:
33038833
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
1,059 SCImago ℠
Cuartil:
Q2 SCImago ℠

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Keywords

  • Adolescent; Adult; Biomarkers; Child; Child, Preschool; Cystic Fibrosis; Cytokines; Docosahexaenoic Acids; Double-Blind Method; Female; Humans; Infant; Lactic Acid; Leukocyte Elastase; Leukocyte L1 Antigen Complex; Male; Time Factors; antibiotic agent; biological marker; C reactive protein; calgranulin; docosahexaenoic acid; interleukin 10; interleukin 1beta; interleukin 6; interleukin 8; lactic acid; leukocyte elastase; placebo; tumor necrosis factor; biological marker; calgranulin; cytokine; docosahexaenoic acid; ELANE protein, human; lactic acid; leukocyte elastase; adolescent; Article; child; clinical outcome; controlled study; cystic fibrosis; disease exacerbation; double blind procedure; drug effect; drug safety; drug use; enteritis; female; forced expiratory volume; gastrointestinal disease; human; incidence; infection; long term care; major clinical study; male; multicenter study; neurologic disease; nutritional status; parallel design; patient compliance; pneumonia; priority j

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