Department of Medical Sciences, Cumming School of Medicine , University of Calgary , Calgary, AB , Canada.
Department of Community Health Sciences, Cumming School of Medicine , University of Calgary , Calgary, AB , Canada.
Clin Kidney J. 2015 Feb;8(1):41-8. doi: 10.1093/ckj/sfu122. Epub 2014 Dec 2.
Vitamin D deficiency is highly prevalent in patients with chronic kidney disease (CKD) and has been associated with all-cause and cardiovascular mortality in observational studies. However, evidence from randomized controlled trials (RCTs) supporting vitamin D supplementation is lacking. We sought to assess whether vitamin D supplementation alters the relative risk (RR) of all-cause and cardiovascular mortality, as well as serious adverse cardiovascular events, in patients with CKD, compared with placebo.
PubMed/MEDLINE, EMBASE, Cochrane Library, and selected nephrology journals and conference proceedings were searched in October 2013. RCTs considered for inclusion were those that assessed oral vitamin D supplementation versus placebo in adults with CKD (≤60 mL/min/1.73 m(2)), including end-stage CKD requiring dialysis. We calculated pooled RR of mortality (all-cause and cardiovascular) and that of cardiovascular events and stratified by CKD stage, vitamin D analog and diabetes prevalence.
The search identified 4246 articles, of which 13 were included. No significant treatment effect of oral vitamin D on all-cause mortality (RR: 0.84; 95% CI: 0.47, 1.52), cardiovascular mortality (RR: 0.79; 95% CI: 0.26, 2.28) or serious adverse cardiovascular events (RR: 1.20; 95% CI: 0.49, 2.99) was observed. The pooled analysis demonstrated large variation in trials with respect to dosing (0.5 ug-200 000 IU/week) and duration (3-104 weeks).
Current RCTs do not provide sufficient or precise evidence that vitamin D supplementation affects mortality or cardiovascular risk in CKD. While its effect on biochemical endpoints is well documented, the results demonstrate a lack of appropriate patient-level data within the CKD literature, which warrants larger trials with clinical primary outcomes related to vitamin D supplementation.
维生素 D 缺乏症在慢性肾脏病（CKD）患者中非常普遍，并且在观察性研究中与全因和心血管死亡率相关。然而，缺乏支持维生素 D 补充的随机对照试验（RCT）的证据。我们试图评估与安慰剂相比，维生素 D 补充是否会改变 CKD 患者的全因和心血管死亡率以及严重不良心血管事件的相对风险（RR）。
2013 年 10 月，检索了 PubMed/MEDLINE、EMBASE、Cochrane 图书馆以及选定的肾脏病学杂志和会议记录。纳入的 RCT 评估了口服维生素 D 补充剂与安慰剂在 CKD（≤60 mL/min/1.73 m²）成人中的疗效，包括需要透析的终末期 CKD。我们计算了死亡率（全因和心血管）和心血管事件的 RR，并按 CKD 分期、维生素 D 类似物和糖尿病患病率进行分层。
搜索共确定了 4246 篇文章，其中 13 篇被纳入。口服维生素 D 对全因死亡率（RR：0.84；95%CI：0.47，1.52）、心血管死亡率（RR：0.79；95%CI：0.26，2.28）或严重不良心血管事件（RR：1.20；95%CI：0.49，2.99）均无显著治疗作用。荟萃分析表明，试验在剂量（0.5 ug-200 000 IU/周）和持续时间（3-104 周）方面存在较大差异。
目前的 RCT 没有提供足够或精确的证据表明维生素 D 补充会影响 CKD 患者的死亡率或心血管风险。虽然其对生化终点的影响已有充分的文献记载，但结果表明 CKD 文献中缺乏适当的患者水平数据，这需要更大规模的临床试验，以维生素 D 补充为相关的临床主要结局。
