Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 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 D3 supplementation may be used prophylactically as an affordable and safe strategy that could be added to the...

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Main Authors: Miguel Cervero, Daniel López-Wolf, Guiomar Casado, Maria Novella-Mena, Pablo Ryan-Murua, María Luisa Taboada-Martínez, Sara Rodríguez-Mora, Lorena Vigón, Mayte Coiras, Montserrat Torres
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-07-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.863587/full
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author Miguel Cervero
Daniel López-Wolf
Guiomar Casado
Maria Novella-Mena
Pablo Ryan-Murua
María Luisa Taboada-Martínez
Sara Rodríguez-Mora
Lorena Vigón
Mayte Coiras
Montserrat Torres
author_facet Miguel Cervero
Daniel López-Wolf
Guiomar Casado
Maria Novella-Mena
Pablo Ryan-Murua
María Luisa Taboada-Martínez
Sara Rodríguez-Mora
Lorena Vigón
Mayte Coiras
Montserrat Torres
author_sort Miguel Cervero
collection DOAJ
description 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 D3 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 D3 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.
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spelling doaj.art-61a0e3e2461349a7b9639d88008fda452022-12-22T02:46:41ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-07-011310.3389/fphar.2022.863587863587Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical TrialMiguel Cervero0Daniel López-Wolf1Guiomar Casado2Maria Novella-Mena3Pablo Ryan-Murua4María Luisa Taboada-Martínez5Sara Rodríguez-Mora6Lorena Vigón7Mayte Coiras8Montserrat Torres9Internal Medicine Service, Hospital Universitario Severo Ochoa, Leganés, SpainInternal Medicine Service, Hospital Universitario Fundación Alcorcón, Alcorcón, SpainImmunopathology Unit, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, SpainInternal Medicine Service, Hospital Universitario Príncipe de Asturias, Madrid, SpainInternal Medicine Service, Hospital Universitario Infanta Leonor, Madrid, SpainInternal Medicine Service, Hospital Universitario de Cabueñes, Gijón, SpainImmunopathology Unit, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, SpainImmunopathology Unit, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, SpainImmunopathology Unit, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, SpainImmunopathology Unit, National Center of Microbiology, Instituto de Salud Carlos III, Madrid, SpainThere 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 D3 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 D3 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.https://www.frontiersin.org/articles/10.3389/fphar.2022.863587/fullCOVID-19SARS-CoV-2vitamin D3 supplementationbiochemical parametersrisk factors
spellingShingle Miguel Cervero
Daniel López-Wolf
Guiomar Casado
Maria Novella-Mena
Pablo Ryan-Murua
María Luisa Taboada-Martínez
Sara Rodríguez-Mora
Lorena Vigón
Mayte Coiras
Montserrat Torres
Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
Frontiers in Pharmacology
COVID-19
SARS-CoV-2
vitamin D3 supplementation
biochemical parameters
risk factors
title Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
title_full Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
title_fullStr Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
title_full_unstemmed Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
title_short Beneficial Effect of Short-Term Supplementation of High Dose of Vitamin D3 in Hospitalized Patients With COVID-19: A Multicenter, Single-Blinded, Prospective Randomized Pilot Clinical Trial
title_sort beneficial effect of short term supplementation of high dose of vitamin d3 in hospitalized patients with covid 19 a multicenter single blinded prospective randomized pilot clinical trial
topic COVID-19
SARS-CoV-2
vitamin D3 supplementation
biochemical parameters
risk factors
url https://www.frontiersin.org/articles/10.3389/fphar.2022.863587/full
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