Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D 3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial.

There is now sufficient evidence to support that vitamin D deficiency may predispose to SARS-CoV-2 infection and increase COVID-19 severity and mortality. It has been suggested that vitamin D ₃ supplementation may be used prophylactically as an affordable and safe strategy that could be added to the existing COVID-19 standard treatment. This multicenter, single-blinded, prospective randomized pilot clinical trial aimed to evaluate the safety, tolerability, and effectiveness of 10,000 IU/day in comparison with 2000 IU/day of cholecalciferol supplementation for 14 days to reduce the duration and severity of COVID-19 in 85 hospitalized individuals. The median age of the participants was 65 years (Interquartile range (IQR): 53-74), most of them (71%) were men and the mean baseline of 25-hydroxyvitamin D (25(OH)D) in serum was 15 ng/ml (standard deviation (SD):6). After 14 days of supplementation, serum 25(OH)D levels were significantly increased in the group who received 10,000IU/day ( p < 0.0001) ( n = 44) in comparison with the 2,000IU/day group ( n = 41), especially in overweight and obese participants, and the higher dose was well tolerated. A fraction of the individuals in our cohort (10/85) developed acute respiratory distress syndrome (ARDS). The median length of hospital stay in these patients with ARDS was significantly different in the participants assigned to the 10,000IU/day group ( n = 4; 7 days; IQR: 4-13) and the 2,000IU/day group ( n = 6; 27 days; IQR: 12-45) ( p = 0.04). Moreover, the inspired oxygen fraction was reduced 7.6-fold in the high dose group ( p = 0.049). In terms of blood parameters, we did not identify overall significant improvements, although the platelet count showed a modest but significant difference in those patients who were supplemented with the higher dose ( p = 0.0492). In conclusion, the administration of 10,000IU/day of vitamin D ₃ for 14 days in association with the standard clinical care during hospitalization for COVID-19 was safe, tolerable, and beneficial, thereby helping to improve the prognosis during the recovery process.
Competing Interests: Drug Cholecalciferol (vitamin D) used in this study was donated by Italfarmaco Group (Cholecalciferol 25,000IU/2.5 ml oral solution). Italfarmaco Group had no role in the design and conduct of the study, in the collection, management, analysis, and interpretation of the data, or the preparation, review, or approval of the manuscript.
(Copyright © 2022 Cervero, López-Wolf, Casado, Novella-Mena, Ryan-Murua, Taboada-Martínez, Rodríguez-Mora, Vigón, Coiras and Torres.)