每日补充 4000IU 维生素 D 与安慰剂对晚期心力衰竭贫血患病率的影响：EVITA 试验。
Randomized supplementation of 4000 IU vitamin D daily vs placebo on the prevalence of anemia in advanced heart failure: the EVITA trial.
机构信息
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, D-32545, Bad Oeynhausen, Germany.
Institute for Laboratory and Transfusion Medicine, Heart- and Diabetes Center NRW, Ruhr University Bochum, Bochum, Bad Oeynhausen, Germany.
出版信息
Nutr J. 2017 Aug 23;16(1):49. doi: 10.1186/s12937-017-0270-5.
BACKGROUND
Low 25-hydroxyvitamin D (25OHD) levels (< 75 nmol/l) are inversely associated with anemia prevalence. Since anemia and low 25OHD levels are common in patients with heart failure (HF), we aimed to investigate whether vitamin D supplementation can reduce anemia prevalence in advanced HF.
METHODS
EVITA (Effect of Vitamin D on Mortality in Heart Failure) is a randomized, placebo-controlled clinical trial in patients with initial 25OHD levels < 75 nmol/l. Participants received either 4000 IU vitamin D daily or a matching placebo for 36 months. A total of 172 patients (vitamin D group: n = 85; placebo group: n = 87) were investigated in this pre-specified secondary data analysis. Hemoglobin (Hb) and other hematological parameters were measured at baseline and study termination. Assessment of between-group differences in anemia prevalence and Hb concentrations was performed at study termination, while adjusting for baseline differences.
RESULTS
In the vitamin D and placebo group, baseline proportions of patients with anemia (Hb < 12.0 g/dL in females and < 13.0 g/dL in males) were 17.2% and 10.6%, respectively (P = 0.19). At study termination, the proportion of patients with anemia in the vitamin D and placebo groups was 32.2% and 31.8%, respectively (P > 0.99). There was no between-group difference in change in the Hb concentrations (- 0.04 g/dL [95%CI:-0.53 to 0.45 g/dL]; P = 0.87). Results regarding anemia risk and Hb concentrations were similar in the subgroup of patients with chronic kidney disease (vitamin D group: n = 26; placebo group: n = 23). Moreover, results did not differ substantially when data analysis was restricted to patients with deficient baseline 25OHD levels.
CONCLUSIONS
A daily vitamin D supplement of 4000 IU did not reduce anemia prevalence in patients with advanced HF. Data challenge the clinical relevance of vitamin D supplementation to increase Hb levels.
TRIAL REGISTRATION
The study was registered at EudraCT (No. 2010-020793-42) and clinicaltrials.gov ( NCT01326650 ).
背景
低 25-羟维生素 D（25OHD）水平（<75 nmol/L）与贫血患病率呈负相关。由于贫血和低 25OHD 水平在心力衰竭（HF）患者中很常见，我们旨在研究维生素 D 补充是否可以降低晚期 HF 患者的贫血患病率。
方法
EVITA（维生素 D 对心力衰竭死亡率的影响）是一项在初始 25OHD 水平<75 nmol/L 的患者中进行的随机、安慰剂对照临床试验。参与者每天接受 4000IU 维生素 D 或匹配的安慰剂治疗 36 个月。共有 172 名患者（维生素 D 组：n=85；安慰剂组：n=87）在本预先指定的二次数据分析中进行了研究。在基线和研究结束时测量血红蛋白（Hb）和其他血液学参数。在研究结束时，调整基线差异后，评估贫血患病率和 Hb 浓度的组间差异。
结果
在维生素 D 组和安慰剂组中，基线时贫血患者（女性 Hb<12.0g/dL，男性 Hb<13.0g/dL）的比例分别为 17.2%和 10.6%（P=0.19）。在研究结束时，维生素 D 组和安慰剂组贫血患者的比例分别为 32.2%和 31.8%（P>0.99）。Hb 浓度的变化在两组之间没有差异（-0.04g/dL[95%CI：-0.53 至 0.45g/dL]；P=0.87）。在慢性肾脏病患者亚组中（维生素 D 组：n=26；安慰剂组：n=23），贫血风险和 Hb 浓度的结果相似。此外，当将数据分析限制在基线 25OHD 水平不足的患者时，结果没有显著差异。
结论
每天补充 4000IU 维生素 D 不能降低晚期 HF 患者的贫血患病率。数据对维生素 D 补充以增加 Hb 水平的临床相关性提出了挑战。
试验注册
该研究在 EudraCT（编号 2010-020793-42）和 clinicaltrials.gov（NCT01326650）上注册。
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