Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19 A Randomized Clinical Trial
Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19 A Randomized Clinical Trial
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DOI：
10.1001/jama.2020.26848
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发表时间：
2021-02-17
影响因子：
120.7
通讯作者：
Pereira, Rosa M. R.
中科院分区：
文献类型：
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作者：
Murai, Igor H.;Fernandes, Alan L.;Pereira, Rosa M. R.
重要性维生素D-3补充剂在2019冠状病毒病（COVID-19）中的疗效尚不清楚。目的研究单次高剂量维生素D-3对COVID-19患者住院时间的影响。设计、设置和参与者这是一项多中心、双盲、随机、安慰剂对照试验，在巴西圣保罗的2个地点进行。该研究包括240名住院的COVID-19患者，他们在2020年6月2日至2020年8月27日入组时患有中度至重度疾病。最后一次随访时间为2020年10月7日。干预患者被随机分配接受单次口服200 000 IU维生素D-3（n = 120）或安慰剂（n = 120）。主要结局和指标主要结局是住院时间，定义为从随机化日期到出院的时间。预先设定的次要结局包括住院期间的死亡率;入住重症监护室的患者数量;需要机械通气的患者数量和机械通气的持续时间; 240例随机患者中，237例被纳入主要分析，（平均[SD]年龄：56.2 [14.4]岁; 104名[43.9%]女性;平均[SD]基线25-羟基维生素D水平：20.9 [9.2] ng/mL）。维生素D-3组（7.0 [4.0-10.0]天）和安慰剂组（7.0 [5.0-13.0]天）的中位（四分位距）住院时间无显著差异（对数秩P = 0.59;未校正的出院风险比，1.07 [95%CI，0.82-1.39]; P = 0.62）。维生素D-3组和安慰剂组的住院死亡率差异不显著（7.6% vs 5.1%;差异，2.5% [95% CI，-4.1%至9.2%]; P = 0.43），入住重症监护室（16.0% vs 21.2%;差异，-5.2% [95% CI，-15.1%至4.7%]; P = 0.30）或需要机械通气（7.6% vs 14.4%;差异，-6.8% [95% CI，-15.1%至1.2%]; P = 0.09）。与安慰剂相比，单剂量维生素D-3后25-羟基维生素D的平均血清水平显著升高（44.4 ng/mL vs 19.8 ng/mL;差异为24.1 ng/mL [95% CI，19.5-28.7]; P <0.001）。没有出现不良事件，但呕吐事件与干预有关。结论和相关性在住院的COVID-19患者中，与安慰剂相比，单次服用高剂量的维生素D-3并未显着缩短住院时间。研究结果不支持使用高剂量维生素D-3治疗中度至重度COVID-19。
IMPORTANCE The efficacy of vitamin D-3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear.OBJECTIVE To investigate the effect of a single high dose of vitamin D-3 on hospital length of stay in patients with COVID-19.DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020.INTERVENTIONS Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D-3 (n = 120) or placebo (n = 120).MAIN OUTCOMES AND MEASURES The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein.RESULTS Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D-3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P = .62). The difference between the vitamin D-3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, -4.1% to 9.2%]; P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, -5.2% [95% CI, -15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference, -6.8% [95% CI, -15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D-3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events, but an episode of vomiting was associated with the intervention.CONCLUSIONS AND RELEVANCE Among hospitalized patients with COVID-19, a single high dose of vitamin D-3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D-3 for treatment of moderate to severe COVID-19.