Department of Pharmaceutical & Health Sciences, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.
Department of Nephrology, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
Clin Nutr ESPEN. 2021 Feb;41:129-135. doi: 10.1016/j.clnesp.2020.12.004. Epub 2020 Dec 31.
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.
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.
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.
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.
二十二碳六烯酸（DHA）是一种饮食中的 n-3 多不饱和脂肪酸 ω-3（n-3、PUFA），它在降低血液透析（HD）患者全因死亡率方面显示出潜在的有益作用。本随机试验旨在分析 DHA 补充剂是否可调节血液透析（HD）患者的促红细胞生成素（EPO）反应和炎症。
在这项对照临床试验中，52 名 HD 患者被随机分为 DHA 补充组（650mg DHA/3 次/周/HD 后）或对照组（常规护理），随访 8 周。主要结局是通过改变红细胞生成抵抗指数（ERI）来确定贫血的纠正情况，使血红蛋白水平达到推荐的靶值。次要结局包括炎症生物标志物的变化：血清 C 反应蛋白、总同型半胱氨酸（tHcy）和 miR-146a 的表达。在 DHA 补充或对照组常规护理 8 周后，在基线和基线时测定实验室指标。线性回归分析用于评估 DHA 补充的效果，调整基线值和干预值。
42 名 HD 患者（男性：69%；年龄：66.7±15.5 岁；DM：19%）完成了这项研究。DHA 的作用可显著减少 EPO 剂量（-4158.7 UI/周；95%CI：-8123.7 至 193.6；p=0.04）、ERI（-9.25 UI/周/kg BW/g/dL；95%CI：-15.5 至-2.9；p=0.006）、tHcy（-5.1 μmol/L；95%CI：-9.7 至-0.3；p=0.03）和 miR-146a 水平（-1.43；95%CI：-2.7 至-0.19；p=0.03），在回归模型中。未发现不良反应。
在这项 HD 患者的对照试验中，DHA 补充作为常规医疗护理的辅助治疗，可以改善贫血管理，并减轻炎症反应。在 CLINICALTRIALS.GOV 登记了注册号：04536636。
