A randomized pilot study using calcitriol in hospitalized COVID-19 patients.
A randomized pilot study using calcitriol in hospitalized COVID-19 patients.
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DOI：
10.1016/j.bone.2021.116175
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发表时间：
2022-01
期刊：
影响因子：
4.1
通讯作者：
Via MA
中科院分区：
文献类型：
--
作者：
Elamir YM;Amir H;Lim S;Rana YP;Lopez CG;Feliciano NV;Omar A;Grist WP;Via MA
与SARS-CoV-2感染相关的全身性疾病导致每10万人中有380.3人住院，压倒了卫生保健系统。维生素D调节大约11，000个基因的表达，这些基因跨越许多生理功能，包括先天性和适应性免疫功能的调节。我们调查了骨化三醇治疗对因COVID-19住院的患者的潜在益处。这是一项对住院的COVID-19成人患者进行骨化三醇或不进行治疗的开放标签、随机临床试验。受试者被随机分配接受每日0.5 μg钙三醇治疗，持续14天或出院;或在入组时不接受治疗（1：1）。我们连续招募了50名患者，每个试验组25名，计算两组患者入院和出院时外周动脉血氧饱和度与吸入氧分数（SaO 2/FIO 2比值）的变化。对照组出院时平均增加+13.2（±127.7），骨化三醇组增加+91.04（±119.08）（p = 0.0305），表明接受骨化三醇的受试者的氧合改善。此外，对照组中有12名患者入院时需要补充氧气，其中21名患者出院时可以呼吸室内空气。骨化三醇组中有14名受试者在入院时需要补充氧气，而所有25名受试者均在室内空气中出院。其他临床指标显示，对照组的平均住院时间为9.24（±9.4）天，而骨化三醇组为5.5（±3.9）天（p = 0.14）。对照组和骨化三醇组分别有8例和5例需要转入ICU。对照组有3例死亡和4例再入院，骨化三醇组有0例死亡和2例再入院。这项初步研究说明了接受骨化三醇治疗的COVID-19住院患者的氧合改善，并表明需要进行更大规模的随机试验。
The systemic illness associated with SARS-CoV-2 infection results in hospitalization rate of 380.3 hospitalizations per 100,000 population, overwhelming health care systems. Vitamin D regulates expression of approximately 11,000 genes spanning many physiologic functions that include regulation of both innate and adaptive immune function. We investigate potential benefit of calcitriol therapy given to patients hospitalized with COVID-19. This was an open label, randomized clinical trial of calcitriol or no treatment given to hospitalized adult patients with COVID-19. Subjects were randomly assigned treatment with calcitriol 0.5 μg daily for 14 days or hospital discharge; or no treatment (1:1) at time of enrollment. We enrolled 50 consecutive patients, 25 per trial arm. The change in peripheral arterial oxygen saturation to the inspired fraction of oxygen (SaO2/FIO2 ratio) was calculated on admission and discharge between the groups. The control group had an average increase of +13.2 (±127.7) on discharge and the calcitriol group had an increase of +91.04 (±119.08) (p = .0305), suggesting an improvement in oxygenation among subjects who received calcitriol. Additionally, 12 patients in the control group required oxygen supplementation on admission and 21 of them were discharged on room air. 14 subjects needed oxygen supplementation in the calcitriol group on admission while all 25 were discharged on room air. Other clinical markers showed the average length of stay was 9.24 (±9.4) in the control group compared to 5.5 (±3.9) days in the calcitriol group (p = .14). The need for ICU transfer was 8 in the control group and 5 in the calcitriol group. There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group. This pilot study illustrates improvement in oxygenation among hospitalized patients with COVID-19 treated with calcitriol and suggests the need for a larger randomized trial.
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