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Influence of a High Vitamin D2 Dose on the Prevention and Improvement of Symptomatic COVID-19 in Health Care Workers: A Multicenter Randomized Clinical Trial

28 Pages Posted: 29 Mar 2023

See all articles by Huan wang

Huan wang

Peking University - Peking University Third Hospital

Chunli Song

Peking University - Department of Orthopedics

Liyuan Tao

Harvard University

Liyan Cui

Peking University - Peking University Third Hospital

Yahong Chen

Peking University - Peking University Third Hospital

Dongyang Liu

Peking University - Peking University Third Hospital

Lixiang Xue

Peking University - Peking University Third Hospital

Yuping Yang

Peking University - Peking University Third Hospital

Yang Lv

Peking University - Peking University Third Hospital

Fuchun Zhang

Beijing Haidian Maternal and Child Health Hospital

Tiancheng Wang

Peking University - Peking University Third Hospital

Xiaoxiao Wang

Peking University - Research Center of Clinical Epidemiology

Wanqiong Yuan

Peking University, Third Hospital, Department of Orthopedics

Hao Liu

Peking University - Peking University Third Hospital

Jie Huang

Peking University - Peking University Third Hospital

Yanfang Jiang

Peking University - Peking University Third Hospital

Na Liu

Beijing Haidian Maternal and Child Health Hospital

Liyuan Yang

Peking University - Peking University Third Hospital

Yunjing Hu

Peking University - Peking University Third Hospital

Yanfang Li

Peking University - Peking University Third Hospital

Yuling Gao

Peking University - Peking University Third Hospital

Haiyan Li

Peking University - Peking University Third Hospital

Baohua Li

Peking University - Peking University Third Hospital

More...

Abstract

Background: COVID-19 pandemic exacerbates infections among health care workers, highlighting importance of prevention for these high-risk people. Vitamin D, as an immunomodulator, is thought likely to be to correlate with the inflammatory reaction.

Methods: This was a multicenter, open-label, randomized controlled trial. The study recruited 228 health care workers who tested negative PCR or antigen for COVID-19. Subjects were randomly allocated to 200, 000 IU vitamin D2 fortnightly or non-intervention at a ratio 1:1. PCR or antigen tests were taken at baseline and twice a week during the follow-up visit. The concentration of serum 25-hydroxyvitamin D (25(OH)D), C-reaction protein (CRP), complement component C1q and inflammatory cytokines (IL-1β, IFN-α, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12, IL-17A, IL-18, IL-23, and IL-33) were measured at baseline and on the thirtieth day of this trial. Subjects recorded the symptoms of COVID-19 and essential information in the electronic questionnaire twice a week during the whole trial. The during of the trial was one month.

Findings: The rates of COVID-19 infection were 50% in the vitamin D2 group and 54% in the no intervention group (P= 0.785), and the durations of PCR or antigen testing from positive to negative after COVID-19 infection were 6.6 days and 7.4 days, respectively. There was no difference in the COVID-19 symptoms between the two groups. The mean 25(OH)D level significantly increased after high doses of vitamin D2 administration compared with the non-intervention group (from 14.1 ng/mL to 31.1 ng/mL vs. from 14.4 ng/mL to 15.3 ng/mL). The difference between the two groups was not significant for the concentrations of CRP, complement component C1q and inflammatory cytokines on the thirtieth day of the trial. In the safety analysis, high-dose vitamin D2 administration was well tolerated by the subjects, and no subjects stopped the trial because of adverse events in the high-dose vitamin D2 group.

Interpretation: Our study indicated that the administration of high-dose vitamin D2 did not significantly reduce the rate of COVID-19 infection, and it was not related to the symptoms of COVID-19 in health care workers. Administering 200,000 IU vitamin D2 was well tolerated by the subjects, and no severe adverse events occurred during the trial. There is a serious vitamin D deficiency and insufficiency in health care workers in China that more attention should be given to the supplement of vitamin D.

Trial Registration: NCT05673980.

Funding: This work was supported by the National Key Research and Development Program (grant nos. 2020YFC2009004, 2021YFC2501700) and the National Natural Science Foundation of China (Grant no. 82272554).

Declaration of Interest: The authors declare that this research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Ethical Approval: This study was approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2022828). The subjects provided written informed consent before participation.

Keywords: COVID-19, Health care workers, Vitamin D2, Prevention, Severity

Suggested Citation

wang, Huan and Song, Chunli and Tao, Liyuan and Cui, Liyan and Chen, Yahong and Liu, Dongyang and Xue, Lixiang and Yang, Yuping and Lv, Yang and Zhang, Fuchun and Wang, Tiancheng and Wang, Xiaoxiao and Yuan, Wanqiong and Liu, Hao and Huang, Jie and Jiang, Yanfang and Liu, Na and Yang, Liyuan and Hu, Yunjing and Li, Yanfang and Gao, Yuling and Li, Haiyan and Li, Baohua, Influence of a High Vitamin D2 Dose on the Prevention and Improvement of Symptomatic COVID-19 in Health Care Workers: A Multicenter Randomized Clinical Trial. Available at SSRN: https://ssrn.com/abstract=4401710 or http://dx.doi.org/10.2139/ssrn.4401710

Huan Wang

Peking University - Peking University Third Hospital ( email )

Chunli Song (Contact Author)

Peking University - Department of Orthopedics ( email )

Beijing, 100191
China

Liyuan Tao

Harvard University ( email )

1875 Cambridge Street
Cambridge, MA 02138
United States

Liyan Cui

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yahong Chen

Peking University - Peking University Third Hospital ( email )

Beijing
China

Dongyang Liu

Peking University - Peking University Third Hospital ( email )

Beijing
China

Lixiang Xue

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yuping Yang

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yang Lv

Peking University - Peking University Third Hospital ( email )

Beijing
China

Fuchun Zhang

Beijing Haidian Maternal and Child Health Hospital ( email )

Tiancheng Wang

Peking University - Peking University Third Hospital ( email )

Beijing
China

Xiaoxiao Wang

Peking University - Research Center of Clinical Epidemiology ( email )

Wanqiong Yuan

Peking University, Third Hospital, Department of Orthopedics ( email )

Hao Liu

Peking University - Peking University Third Hospital ( email )

Beijing
China

Jie Huang

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yanfang Jiang

Peking University - Peking University Third Hospital ( email )

Beijing
China

Na Liu

Beijing Haidian Maternal and Child Health Hospital ( email )

Liyuan Yang

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yunjing Hu

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yanfang Li

Peking University - Peking University Third Hospital ( email )

Beijing
China

Yuling Gao

Peking University - Peking University Third Hospital ( email )

Beijing
China

Haiyan Li

Peking University - Peking University Third Hospital ( email )

Beijing
China

Baohua Li

Peking University - Peking University Third Hospital ( email )

Beijing
China

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