Study design (if review, criteria of inclusion for studies)
Randomized, double-blind, parallel, placebo-controlled trial.
96 CF patients (age >2 months) 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included.
Patients 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-1Î², IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1Î², IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV(1), pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
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.
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).