Abstract
Objective: The goal of this randomized, double-blinded, placebo-controlled clinical trial was to investigate the therapeutic efficacy of oral 25-hydroxyvitamin D 3 (25(OH)D 3 ) in improving vitamin D status in vitamin D-deficient/vitamin D-insufficient patients infected with the SARS-CoV-2 (COVID-19) virus.
Methods: This is a multicenter, randomized, double-blinded, placebo-controlled clinical trial. Participants were recruited from 3 hospitals that are affiliated to [Institution Blinded for Review] and [Institution Blinded for Review].
Results: A total 106 hospitalized patients who had a circulating 25(OH)D 3 concentration of <30 ng/mL were enrolled in this study. Within 30 and 60 days, 76.4% (26 of 34) and 100% (24 of 24) of the patients who received 25(OH)D 3 had a sufficient circulating 25(OH)D 3 concentration, whereas ≤12.5% of the patients in the placebo group had a sufficient circulating 25(OH)D 3 concentration during the 2-month follow-up. We observed an overall lower trend for hospitalization, intensive care unit duration, need for ventilator assistance, and mortality in the 25(OH)D 3 group compared with that in the placebo group, but differences were not statistically significant. Treatment with oral 25(OH)D 3 was associated with a significant increase in the lymphocyte percentage and decrease in the neutrophil-to-lymphocyte ratio in the patients. The lower neutrophil-to-lymphocyte ratio was significantly associated with reduced intensive care unit admission days and mortality.
Conclusion: Our analysis indicated that oral 25(OH)D 3 was able to correct vitamin D deficiency/insufficiency in patients with COVID-19 that resulted in improved immune function by increasing blood lymphocyte percentage. Randomized controlled trials with a larger sample size and higher dose of 25(OH)D 3 may be needed to confirm the potential effect of 25(OH)D 3 on reducing clinical outcomes in patients with COVID-19.
Keywords: 25-hydroxyvitamin D(3); COVID-19; lymphocyte; supplementation; viral infection; vitamin D deficiency.
【저자키워드】 COVID-19, viral infection, vitamin D deficiency, lymphocyte, Supplementation, 25-hydroxyvitamin D3, 25-hydroxyvitamin D(3), 【초록키워드】 Mortality, intensive care, Hospitalization, 25-hydroxyvitamin D, hospital, virus, Neutrophil-to-lymphocyte ratio, Clinical outcome, Randomized, Patient, Controlled trial, immune function, Follow-up, multicenter, Admission, patients, Vitamin D status, Concentration, Analysis, dose, deficiency, Sample size, ventilator, double-blinded, significant increase, therapeutic efficacy, placebo-controlled clinical trial, participant, circulating, decrease, enrolled, significantly, recruited, indicated, the patient, reduced, hospitalized patient, reducing, statistically significant, blood lymphocyte, patients with COVID-19, the placebo group, the SARS-CoV-2, 【제목키워드】 calcifediol, clinical, Ratio,