d594b6db512c13a13b2bfcb0977aa1c9 pmc_11013158.pdf b78f0070d42f344b123a353295153dc51ea7d9fc pmc_11013158.pdf ca10e52c3680e381ef346c796bcab224edad107ecc3f8253c9dad7c1465d8109 pmc_11013158.pdf Title: Impact of 1-Year Supplementation with High-Rich Docosahexaenoic Acid (DHA) on Clinical Variables and Inflammatory Biomarkers in Pediatric Cystic Fibrosis: A Randomized Double-Blind Controlled Trial Subject: A randomized, double-blind, and placebo-controlled study was conducted to assess the effect of dietary supplementation with high-rich docosahexaenoic acid (DHA) (Tridocosahexanoin-AOX® 70%) at 50 mg/kg/day in pediatric patients with cystic fibrosis (CF) as compared with placebo. The duration of supplementation was 12 months. A total of 22 patients were included, with 11 in the DHA group and 11 in the placebo group. The mean age was 11.7 years. The outcome variables were pulmonary function, exacerbations, sputum cellularity, inflammatory biomarkers in sputum and peripheral blood, and anthropometric variables. In the DHA group, there was a significant increase in FVC (p = 0.004) and FVE1 expressed in liters (p = 0.044) as compared with placebo, and a lower median number of exacerbations (1 vs. 2). Differences in sputum cellularity (predominantly neutrophilic), neutrophilic elastase, and sputum and serum concentrations of resolvin D1 (RvD1), interleukin (IL)-8 (IL-8), and tumor necrosis factor alpha (TNF-) between the study groups were not found. Significant increases in weight and height were also observed among DHA-supplemented patients. The administration of the study product was safe and well tolerated. In summary, the use of a highly concentrated DHA supplement for 1 year as compared with placebo improved pulmonary function and reduced exacerbations in pediatric CF. Keywords: cystic fibrosis; omega-3 fatty acids; docosahexaenoic acid; pulmonary function; inflammatory biomarkers; randomized controlled trial Author: Roser Ayats-Vidal, Montserrat Bosque-García, Begoña Cordobilla, Oscar Asensio-De la Cruz, Miguel García-González, Susana Loureda-Pérez, Elena Fernández-López, Eva Robert-Barriocanal, Andrea Valiente-Planas and Joan Carles Domingo Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Thu Mar 28 08:41:48 2024 CET ModDate: Thu Mar 28 10:11:26 2024 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 17 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 3408747 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- JYPLJJ+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 ZXDKIP+EURM10 Type 1 Builtin yes yes yes 16 0 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yes yes 478 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-04-25 02:42:51 CEST RepresentationInformation: pmc_11013158.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-04-24 02:31:00 CEST Size: 3408747 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 661 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Study Design and Participants Destination: subsection.2.1 Item: Title: Randomization and Intervention Destination: subsection.2.2 Item: Title: Study Procedures Destination: subsection.2.3 Item: Title: Study Variables Destination: subsection.2.4 Item: Title: Study Endpoints Destination: subsection.2.5 Item: Title: Statistical Analysis Destination: subsection.2.6 Item: Title: Results Destination: section.3 Children: Item: Title: Pulmonary Function and Exacerbations Destination: subsection.3.1 Item: Title: Sputum Cellularity Destination: subsection.3.2 Item: Title: Inflammatory Biomarkers Destination: subsection.3.3 Item: Title: Anthropometric Variables Destination: subsection.3.4 Item: Title: Adverse Events and Compliance Destination: subsection.3.5 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: Impact of 1-Year Supplementation with High-Rich Docosahexaenoic Acid (DHA) on Clinical Variables and Inflammatory Biomarkers in Pediatric Cystic Fibrosis: A Randomized Double-Blind Controlled Trial Author: Roser Ayats-Vidal, Montserrat Bosque-García, Begoña Cordobilla, Oscar Asensio-De la Cruz, Miguel García-González, Susana Loureda-Pérez, Elena Fernández-López, Eva Robert-Barriocanal, Andrea Valiente-Planas and Joan Carles Domingo Subject: A randomized, double-blind, and placebo-controlled study was conducted to assess the effect of dietary supplementation with high-rich docosahexaenoic acid (DHA) (Tridocosahexanoin-AOX® 70%) at 50 mg/kg/day in pediatric patients with cystic fibrosis (CF) as compared with placebo. The duration of supplementation was 12 months. A total of 22 patients were included, with 11 in the DHA group and 11 in the placebo group. The mean age was 11.7 years. The outcome variables were pulmonary function, exacerbations, sputum cellularity, inflammatory biomarkers in sputum and peripheral blood, and anthropometric variables. In the DHA group, there was a significant increase in FVC (p = 0.004) and FVE1 expressed in liters (p = 0.044) as compared with placebo, and a lower median number of exacerbations (1 vs. 2). Differences in sputum cellularity (predominantly neutrophilic), neutrophilic elastase, and sputum and serum concentrations of resolvin D1 (RvD1), interleukin (IL)-8 (IL-8), and tumor necrosis factor alpha (TNF-) between the study groups were not found. Significant increases in weight and height were also observed among DHA-supplemented patients. The administration of the study product was safe and well tolerated. In summary, the use of a highly concentrated DHA supplement for 1 year as compared with placebo improved pulmonary function and reduced exacerbations in pediatric CF. 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