Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
BMC Complement Med Ther. 2024 Feb 21;24(1):97. doi: 10.1186/s12906-024-04393-6.
Vitamin D supplementation for infectious diseases has been discussed, but its role in COVID-19 is unclear. Therefore, this study examined the clinical outcomes of COVID-19 pneumonia patients who received vitamin D supplementation.
This prospective, open-label, randomized controlled trial was conducted in a university hospital between July 2020 and March 2022. The inclusion criteria were patients aged ≥ 18 years with COVID-19 pneumonia patients. The patients were randomized into two groups: an intervention group receiving vitamin D supplementation (alfacalcidol, two mcg orally daily) until discharge and a control group. The clinical outcomes were pneumonia treatment duration, length of hospital stay, and change in pneumonia severity index between enrollment and discharge. Subgroup analysis was conducted for supplemental oxygen use, high-dose corticosteroid administration, evidence of lymphopenia, C-reactive protein concentration, and total serum vitamin D concentration. Adverse events were monitored.
Two hundred ninety-four patients were recruited (147 per group). The two groups did not differ in pneumonia treatment duration to discharge (p = 0.788) or length of hospital stay (p = 0.614). The reduction in the pneumonia severity index between enrollment and discharge was more significant in the intervention group (p = 0.007); a significant decrease was also observed among patients who had C-reactive protein > 30 mg/L (p < 0.001). No adverse reactions were recorded.
Adding active vitamin D to standard treatment may benefit COVID-19 pneumonia patients who require supplemental oxygen or high-dose corticosteroid therapy or who have high C-reactive protein concentrations (> 30 mg/L) upon treatment initiation.
Thai Clinical Trials Registry TCTR20210906005 (retrospectively registered, 6 September 2021).
关于维生素 D 补充剂在传染病中的作用已有讨论,但在 COVID-19 中的作用尚不清楚。因此,本研究旨在探讨接受维生素 D 补充剂的 COVID-19 肺炎患者的临床结局。
这是一项前瞻性、开放性、随机对照临床试验,于 2020 年 7 月至 2022 年 3 月在一所大学医院进行。纳入标准为年龄≥18 岁的 COVID-19 肺炎患者。患者被随机分为两组:干预组接受维生素 D 补充剂(阿法骨化醇,每日口服 2 微克)直至出院,对照组。临床结局为肺炎治疗持续时间、住院时间以及从入组到出院时肺炎严重指数的变化。进行了亚组分析,包括吸氧、大剂量皮质类固醇使用、淋巴细胞减少、C 反应蛋白浓度和总血清维生素 D 浓度的证据。监测不良事件。
共纳入 294 例患者(每组 147 例)。两组患者的肺炎治疗至出院时间(p=0.788)或住院时间(p=0.614)无差异。与对照组相比,干预组患者的肺炎严重指数从入组到出院的降低更为显著(p=0.007);在 C 反应蛋白>30mg/L 的患者中也观察到显著降低(p<0.001)。未记录到不良反应。
在标准治疗的基础上添加活性维生素 D 可能对需要吸氧或大剂量皮质类固醇治疗或治疗开始时 C 反应蛋白浓度较高(>30mg/L)的 COVID-19 肺炎患者有益。
泰国临床试验注册中心 TCTR20210906005(回顾性注册,2021 年 9 月 6 日)。