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维生素 D 补充剂与安慰剂对维生素 D 缺乏症患者原发性高血压的影响:一项双盲随机临床试验。

Effect of vitamin D supplementation versus placebo on essential hypertension in patients with vitamin D deficiency: a double-blind randomized clinical trial.

机构信息

Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.

Clinical Research Development Unit of Shahid Beheshti Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.

出版信息

J Clin Hypertens (Greenwich). 2020 Oct;22(10):1867-1873. doi: 10.1111/jch.13926. Epub 2020 Sep 20.

Abstract

Findings from randomized trials addressing the effect of vitamin D supplementation and blood pressure are inconsistent and have been the subject of recent debate. This study aimed to assess the effect of vitamin D supplementation on primary hypertension. This double-blind randomized clinical trial was conducted on patients aged 26-84 years with essential hypertension from March 2017 to April 2019. Patients with vitamin D insufficiency (serum vitamin D levels 20-30 ng/ml) or vitamin D deficiency (serum vitamin D levels <20 ng/ml) were enrolled in the study. Patients were randomly assigned to receive vitamin D supplementation or placebo. Systolic and diastolic blood pressure was measured before the intervention and one and two months thereafter. Of 208 patients enrolled, 171 patients remained for analysis. The effect of vitamin D supplementation on systolic blood pressure was statistically significant in the first and second months after the intervention (P=0.004 and P=0.024, respectively). The effect of vitamin D supplementation on diastolic blood pressure was statistically significant in the first month after the intervention (P=0.046), but not in the second month (P=0.885). No evidence of drug side effects was reported in the two groups. The results of this trial are suggestive of the potential benefits of vitamin D supplementation on blood pressure end points. Therefore, the use of vitamin D may be recommended as an adjuvant drug in the treatment of essential hypertension in patients with vitamin D deficiency because it is safe and well-tolerated by the patients and can significantly reduce the systolic and diastolic blood pressure. Trial registration: Iranian Registry of Clinical Trials registration number: IRCT201703129014N151.

摘要

随机试验结果表明,维生素 D 补充剂对血压的影响并不一致,这也是近期争议的主题。本研究旨在评估维生素 D 补充剂对原发性高血压的影响。这是一项双盲随机临床试验,于 2017 年 3 月至 2019 年 4 月期间对年龄在 26-84 岁的原发性高血压患者进行。研究纳入了维生素 D 不足(血清维生素 D 水平 20-30ng/ml)或维生素 D 缺乏(血清维生素 D 水平<20ng/ml)的患者。患者被随机分为接受维生素 D 补充剂或安慰剂治疗。在干预前以及干预后 1 个月和 2 个月测量收缩压和舒张压。在纳入的 208 例患者中,171 例患者完成了分析。维生素 D 补充剂对收缩压的影响在干预后 1 个月和 2 个月时均具有统计学意义(P=0.004 和 P=0.024)。维生素 D 补充剂对舒张压的影响在干预后 1 个月时具有统计学意义(P=0.046),但在第 2 个月时无统计学意义(P=0.885)。两组均未报告药物不良反应的证据。本试验结果提示,维生素 D 补充剂可能对血压终点有潜在益处。因此,对于维生素 D 缺乏的原发性高血压患者,维生素 D 可作为辅助药物推荐使用,因为它安全且患者耐受良好,可显著降低收缩压和舒张压。试验注册:伊朗临床试验注册中心注册号:IRCT201703129014N151。

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