Unidad de Investigación en Análisis y Síntesis de la Evidencia, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.
Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.
Arch Med Res. 2022 Jun;53(4):423-430. doi: 10.1016/j.arcmed.2022.04.003. Epub 2022 Apr 18.
Associations between vitamin D (VD) deficiency and the risk of SARS-CoV-2 infection have been documented in cross-sectional population studies. Intervention studies in patients with moderate to severe COVID-19 have failed to consistently document a beneficial effect.
To determine the efficacy and safety of VD-supplementation in the prevention of SARS-CoV-2 infection in highly exposed individuals.
A double-blind, parallel, randomized trial was conducted. Frontline healthcare workers from four hospitals in Mexico City, who tested negative for SARS-CoV-2 infection, were enrolled between July 15 and December 30, 2020. Participants were randomly assigned to receive 4,000 IU VD (VDG) or placebo (PG) daily for 30 d. RT-PCR tests were taken at baseline and repeated if COVID-19 manifestations appeared during follow-up. Serum 25-hydroxyvitamin D3 and antibody tests were measured at baseline and at day 45. Per-protocol and intention-to-treat analysis were conducted.
Of 321 recruited subjects, 94 VDG and 98 PG completed follow-up. SARS-CoV-2 infection rate was lower in VDG than in PG (6.4 vs. 24.5%, p <0.001). The risk of acquiring SARS-CoV-2 infection was lower in the VDG than in the PG (RR: 0.23; 95% CI: 0.09-0.55) and was associated with an increment in serum levels of 25-hydroxyvitamin D3 (RR: 0.87; 95% CI: 0.82-0.93), independently of VD deficiency. No significant adverse events were identified.
Our results suggest that VD-supplementation in highly exposed individuals prevents SARS-CoV-2 infection without serious AEs and regardless of VD status.
横断面人群研究已经证实维生素 D（VD）缺乏与 SARS-CoV-2 感染风险之间存在关联。在患有中度至重度 COVID-19 的患者中进行的干预研究未能一致证明有益效果。
确定 VD 补充剂在预防高度暴露个体 SARS-CoV-2 感染中的疗效和安全性。
进行了一项双盲、平行、随机试验。墨西哥城四家医院的一线医护人员在 2020 年 7 月 15 日至 12 月 30 日期间检测出 SARS-CoV-2 感染呈阴性后入组。参与者被随机分配每天接受 4000IU VD（VDG）或安慰剂（PG）治疗 30 天。在基线和随访期间出现 COVID-19 症状时进行 RT-PCR 检测。在基线和第 45 天测量血清 25-羟维生素 D3 和抗体。进行了按方案和意向治疗分析。
在招募的 321 名受试者中，94 名 VDG 和 98 名 PG 完成了随访。VDG 组 SARS-CoV-2 感染率低于 PG 组（6.4%比 24.5%，p<0.001）。VDG 组感染 SARS-CoV-2 的风险低于 PG 组（RR：0.23；95%CI：0.09-0.55），与血清 25-羟维生素 D3 水平升高相关（RR：0.87；95%CI：0.82-0.93），与 VD 缺乏无关。未发现明显的不良事件。
我们的结果表明，在高度暴露个体中补充 VD 可预防 SARS-CoV-2 感染，且无严重不良事件，与 VD 状态无关。
