Effect of oral administration of docohexanoic acid on anemia and inflammation in hemodialysis patients: A randomized controlled clinical trial

Mar Ruperto; Nuria Rodríguez-Mendiola; Martha Díaz-Domínguez; Sara Giménez-Moyano; M Laura García-Bermejo; Milagros Fernández-Lucas

doi:10.1016/j.clnesp.2020.12.004

Effect of oral administration of docohexanoic acid on anemia and inflammation in hemodialysis patients: A randomized controlled clinical trial

Clin Nutr ESPEN. 2021 Feb:41:129-135. doi: 10.1016/j.clnesp.2020.12.004. Epub 2020 Dec 31.

Authors

Mar Ruperto¹, Nuria Rodríguez-Mendiola², Martha Díaz-Domínguez², Sara Giménez-Moyano³, M Laura García-Bermejo³, Milagros Fernández-Lucas⁴

Affiliations

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.

PMID: 33487255
DOI: 10.1016/j.clnesp.2020.12.004

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.

Trial registration: ClinicalTrials.gov NCT04536636.

Keywords: Anemia; Docohexanoic acid; Hemodialysis; Inflammation; miR-146a.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Oral
Anemia* / drug therapy
Anemia* / etiology
C-Reactive Protein
Humans
Inflammation / drug therapy
Male
Renal Dialysis / adverse effects

Substances

C-Reactive Protein

Associated data

ClinicalTrials.gov/NCT04536636