Divisao de Reumatologia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.
Divisao de Patologia Clinica, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.
Clinics (Sao Paulo). 2021 Nov 26;76:e3549. doi: 10.6061/clinics/2021/e3549. eCollection 2021.
In this ancillary analysis of a multicenter, double-blinded, randomized, placebo-controlled trial, we investigated the effect of a single high dose of vitamin D3 on the length of hospital stay of patients with severe 25-hydroxyvitamin D deficiency and COVID-19.
The primary outcome was length of hospital stay, defined as the total number of days that patients remained hospitalized from the date of randomization until the date of hospital discharge. Secondary outcomes included serum levels of 25-hydroxyvitamin D, mortality during hospitalization, number of patients admitted to the intensive care unit, and number of patients who required mechanical ventilation. ClinicalTrials.gov: NCT04449718.
Thirty-two patients were included in the study. The mean (SD) age was 58.5 (15.6) years, body mass index was 30.8 (8.6) kg/m2, and 25-hydroxyvitamin D level was 7.8 (1.6) ng/mL. No significant difference was observed in the median interquartile range of length of hospital stay between the vitamin D3 group (6.0 [4.0-18.0] days) versus placebo (9.5 [6.3-15.5] days) (log-rank p=0.74; hazard ratio, 1.13 [95% confidence interval (CI), 0.53-2.40]; p=0.76). Vitamin D3 significantly increased serum 25-hydroxyvitamin D levels in the vitamin D3 group compared with that in the placebo group (between-group difference, 23.9 ng/mL [95% CI, 17.7-30.1]; p<0.001).
A dose of 200.000 IU of vitamin D3 did not significantly reduce the length of hospital stay of patients with severe 25-hydroxyvitamin D deficiency and COVID-19.
在一项多中心、双盲、随机、安慰剂对照试验的辅助分析中,我们研究了单次高剂量维生素 D3 对严重 25-羟维生素 D 缺乏和 COVID-19 患者住院时间的影响。
主要结局为住院时间,定义为从随机分组日期到出院日期患者住院的总天数。次要结局包括血清 25-羟维生素 D 水平、住院期间死亡率、入住重症监护病房的患者人数以及需要机械通气的患者人数。ClinicalTrials.gov:NCT04449718。
研究纳入 32 例患者。平均(SD)年龄为 58.5(15.6)岁,体重指数为 30.8(8.6)kg/m2,25-羟维生素 D 水平为 7.8(1.6)ng/mL。维生素 D3 组(6.0 [4.0-18.0] 天)与安慰剂组(9.5 [6.3-15.5] 天)的住院时间中位数(四分位距)无显著差异(对数秩检验 p=0.74;风险比,1.13 [95%置信区间(CI),0.53-2.40];p=0.76)。与安慰剂组相比,维生素 D3 组血清 25-羟维生素 D 水平显著升高(组间差异,23.9ng/mL[95%CI,17.7-30.1];p<0.001)。
200000IU 剂量的维生素 D3 不能显著缩短严重 25-羟维生素 D 缺乏和 COVID-19 患者的住院时间。