探讨单次口服200,000IU维生素D3对中重度COVID-19住院患者抗磷脂抗体的影响。
这是一个事后的,双盲探索性分析,安慰剂对照,在圣保罗的两个中心进行的随机临床试验,巴西。住院的COVID-19患者被随机分配接受维生素D3(n=97)或安慰剂(n=97)。在这个事后分析中,终点是抗β2-糖蛋白-I(aβ2-GP)和抗心磷脂(aCL)抗体的滴度和频率[免疫球蛋白G,M和A(IgG,IgM和IgA)]。
总体平均(SD)年龄为55.3(13.9)岁,身体质量指数(BMI)为32.2(7.1kg/m2),106名参与者(54.6%)为男性。aCLIgG的频率存在显著的时间相互作用组(p=0.046),安慰剂组从基线到出院的值增加[n(%),从13(13.4)到25(25.8)],而维生素D3[从25(25.8)到29(29.9)]。然而,出院时,两组之间aCLIgG的频率没有变化.维生素D3和安慰剂组之间没有发现任何其他自身抗体的显着差异。
这些发现不支持在中度至重度COVID-19住院患者中使用单次口服200,000IU维生素D3来调节自身抗体。
To investigate the effect of a single oral dose of 200,000 IU of vitamin D3 on antiphospholipid antibodies in hospitalized patients with moderate to severe COVID-19.
This is a post-hoc, exploratory analysis from a double-blind, placebo-controlled, randomized clinical trial performed in two centers in Sao Paulo, Brazil. Hospitalized patients with COVID-19 were randomly assigned to receive either vitamin D3 (n = 97) or placebo (n = 97). In this post-hoc analysis, the endpoints were titers and frequency of anti-β2-Glycoprotein-I (aβ2-GP) and Anticardiolipin (aCL) antibodies [Immunoglobulin G, M and A (IgG, IgM and IgA)].
Overall mean (SD) age was 55.3 (13.9) years, Body Mass Index (BMI) was 32.2 (7.1 kg/m2), and 106 participants (54.6 %) were male. There was a significant group by time interaction (p = 0.046) for frequency of aCL IgG, with increased values from baseline to discharge in the placebo group [n (%), from 13 (13.4) to 25 (25.8)] compared to the vitamin D3 [from 25 (25.8) to 29 (29.9)]. However, the frequency of aCL IgG did not change between the groups on discharge. No significant differences between vitamin D3 and placebo groups were found for any other autoantibodies.
These findings do not support the use of a single oral dose of 200,000 IU of vitamin D3 to modulate autoantibodies in hospitalized patients with moderate to severe COVID-19.