Mar Ruperto1, Nuria Rodríguez-Mendiola2, Martha Díaz-Domínguez2, Sara Giménez-Moyano3, M Laura García-Bermejo3, Milagros Fernández-Lucas4. 1. Department of Pharmaceutical & Health Sciences, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain. 2. Department of Nephrology, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain. 3. Biomarkers and Therapeutic Targets Group, Ramon and Cajal Health Research Institute (IRYCIS), RedinRen, Madrid, Spain. 4. Department of Nephrology, Hospital Universitario Ramón y Cajal, Department of Nephrology, Faculty of Medicine, Universidad de Alcalá, IRYCIS, Madrid, Spain. Electronic address: milagros.fernandez@salud.madrid.org.
Abstract
BACKGROUND & AIMS:Docohexanoic acid (DHA), a dietary n-3 polyunsaturated fatty-acid omega-3 (n-3, PUFA), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (HD) patients. This randomized trial aimed to analyze whether DHA supplementation was a modulator of erythropoietin (EPO) response and inflammation in hemodialysis (HD) patients. METHODS: In this controlled clinical trial, 52 HD patients were randomized to either DHA supplementation (650 mg DHA/3 times/wk/post-HD session) or controls (usual care), with 8-weeks of follow-up. The primary outcome was to determine the correction of anemia measured by changes in the erythropoiesis-resistance index (ERI) to keep the hemoglobin level at recommended target value. Secondary outcomes include changes in inflammatory biomarkers: serum C-reactive protein, total homocysteine (tHcy) and expression of miR-146a. Laboratory measures were determined at baseline and at 8-weeks after the DHA supplementation or usual care in controls. Linear regression analysis was used to assess the effect of DHA supplementation, adjusting for baseline values and intervention. RESULTS:Forty-two HD patients (men: 69%; aged:66.7 ± 15.5 yrs; DM:19%), completed this study. The DHA effect significantly decreased EPO doses (-4158.7 UI/weekly; CI95%:-8123.7 to 193,6; p = 0.04), ERI (-9.25 UI weekly/kg BW/g/dL; CI95%:-15.5 to -2.9; p = 0.006), tHcy (-5.1 μmol/L; CI95%:-9.7 to -0.3; p = 0.03), and levels of miR-146a (-1.43; CI95%:-2.7 to -0.19; p = 0.03) in regression model. No adverse effects were found. CONCLUSION: The DHA supplementation enhances anemia management and attenuates inflammation response in this controlled trial in HD patients, when provided as coadjutant therapy together with usual medical care. REGISTERED UNDER CLINICALTRIALS. GOV IDENTIFIER NUMBER: 04536636.
RCT Entities:
BACKGROUND & AIMS:Docohexanoic acid (DHA), a dietary n-3 polyunsaturated fatty-acidomega-3 (n-3, PUFA), showed potential beneficial effects in reducing all-cause mortality in hemodialysis (HD) patients. This randomized trial aimed to analyze whether DHA supplementation was a modulator of erythropoietin (EPO) response and inflammation in hemodialysis (HD) patients. METHODS: In this controlled clinical trial, 52 HDpatients were randomized to either DHA supplementation (650 mg DHA/3 times/wk/post-HD session) or controls (usual care), with 8-weeks of follow-up. The primary outcome was to determine the correction of anemia measured by changes in the erythropoiesis-resistance index (ERI) to keep the hemoglobin level at recommended target value. Secondary outcomes include changes in inflammatory biomarkers: serum C-reactive protein, total homocysteine (tHcy) and expression of miR-146a. Laboratory measures were determined at baseline and at 8-weeks after the DHA supplementation or usual care in controls. Linear regression analysis was used to assess the effect of DHA supplementation, adjusting for baseline values and intervention. RESULTS: Forty-two HDpatients (men: 69%; aged:66.7 ± 15.5 yrs; DM:19%), completed this study. The DHA effect significantly decreased EPO doses (-4158.7 UI/weekly; CI95%:-8123.7 to 193,6; p = 0.04), ERI (-9.25 UI weekly/kg BW/g/dL; CI95%:-15.5 to -2.9; p = 0.006), tHcy (-5.1 μmol/L; CI95%:-9.7 to -0.3; p = 0.03), and levels of miR-146a (-1.43; CI95%:-2.7 to -0.19; p = 0.03) in regression model. No adverse effects were found. CONCLUSION: The DHA supplementation enhances anemia management and attenuates inflammation response in this controlled trial in HDpatients, when provided as coadjutant therapy together with usual medical care. REGISTERED UNDER CLINICALTRIALS. GOV IDENTIFIER NUMBER: 04536636.