Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial
IMPORTANCE: The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear. OBJECTIVE: To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, dou...
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Vitamin D3 COVID-19 Hospital Length of Stay Randomized Clinical Trial Moderate to Severe Ineffective |
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Vitamin D3 COVID-19 Hospital Length of Stay Randomized Clinical Trial Moderate to Severe Ineffective Reis, Bruna Zavarize Murai, Igor Hisashi Fernandes, Alan Lins Sales, Lucas Peixoto Pinto, Ana Jéssica Goessler, Karla Fabiana Duran, Camila da Silva Cendon Silva, Carla Baleeiro Rodrigues Franco, André Silva Macêdo, Marina Barguil Dalmolin, Henrique Helson Herter Baggio, Janaina Balbi, Guilherme Guimarães Moreira Antonangelo, Leila Caparbo, Valéria de Falco Gualano, Bruno Pereira, Rosa Maria Rodrigues Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
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IMPORTANCE: The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear. OBJECTIVE: To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020. INTERVENTIONS: Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 (n = 120) or placebo (n = 120). MAIN OUTCOMES AND MEASURES: The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein. RESULTS: Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P = .62). The difference between the vitamin D3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, –4.1% to 9.2%]; P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, –5.2% [95% CI, –15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference, –6.8% [95% CI, –15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events, but an episode of vomiting was associated with the intervention. CONCLUSIONS AND RELEVANCE: Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19 |
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Reis, Bruna Zavarize Murai, Igor Hisashi Fernandes, Alan Lins Sales, Lucas Peixoto Pinto, Ana Jéssica Goessler, Karla Fabiana Duran, Camila da Silva Cendon Silva, Carla Baleeiro Rodrigues Franco, André Silva Macêdo, Marina Barguil Dalmolin, Henrique Helson Herter Baggio, Janaina Balbi, Guilherme Guimarães Moreira Antonangelo, Leila Caparbo, Valéria de Falco Gualano, Bruno Pereira, Rosa Maria Rodrigues |
author_facet |
Reis, Bruna Zavarize Murai, Igor Hisashi Fernandes, Alan Lins Sales, Lucas Peixoto Pinto, Ana Jéssica Goessler, Karla Fabiana Duran, Camila da Silva Cendon Silva, Carla Baleeiro Rodrigues Franco, André Silva Macêdo, Marina Barguil Dalmolin, Henrique Helson Herter Baggio, Janaina Balbi, Guilherme Guimarães Moreira Antonangelo, Leila Caparbo, Valéria de Falco Gualano, Bruno Pereira, Rosa Maria Rodrigues |
author_sort |
Reis, Bruna Zavarize |
title |
Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
title_short |
Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
title_full |
Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
title_fullStr |
Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
title_full_unstemmed |
Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial |
title_sort |
effect of a single high dose of vitamin d3 on hospital length of dtay in patients with moderate to severe covid-19: a randomized clinical trial |
publisher |
JAMA: The Journal of the American Medical Association |
publishDate |
2024 |
url |
https://repositorio.ufrn.br/handle/123456789/57745 http://dx.doi.org/10.1001/jama.2020.26848 |
work_keys_str_mv |
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ri-123456789-577452024-03-04T19:42:26Z Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial Reis, Bruna Zavarize Murai, Igor Hisashi Fernandes, Alan Lins Sales, Lucas Peixoto Pinto, Ana Jéssica Goessler, Karla Fabiana Duran, Camila da Silva Cendon Silva, Carla Baleeiro Rodrigues Franco, André Silva Macêdo, Marina Barguil Dalmolin, Henrique Helson Herter Baggio, Janaina Balbi, Guilherme Guimarães Moreira Antonangelo, Leila Caparbo, Valéria de Falco Gualano, Bruno Pereira, Rosa Maria Rodrigues Vitamin D3 COVID-19 Hospital Length of Stay Randomized Clinical Trial Moderate to Severe Ineffective IMPORTANCE: The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear. OBJECTIVE: To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020. INTERVENTIONS: Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 (n = 120) or placebo (n = 120). MAIN OUTCOMES AND MEASURES: The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein. RESULTS: Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P = .62). The difference between the vitamin D3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, –4.1% to 9.2%]; P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, –5.2% [95% CI, –15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference, –6.8% [95% CI, –15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events, but an episode of vomiting was associated with the intervention. CONCLUSIONS AND RELEVANCE: Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19 2024-03-04T19:42:05Z 2024-03-04T19:42:05Z 2021-03 article MURAI, Igor Hisashi; FERNANDES, Alan Lins; SALES, Lucas Peixoto; PINTO, Ana Jéssica; GOESSLER, Karla Fabiana; DURAN, Camila da Silva Cendon; SILVA, Carla Baleeiro Rodrigues; FRANCO, André Silva; MACÊDO, Marina Barguil; DALMOLIN, Henrique Helson Herter; BAGGIO, Janaina; BALBI, Guilherme Guimarães Moreira; REIS, Bruna Zavarize; ANTONANGELO, Leila; CAPARBO, Valéria de Falco; GUALANO, Bruno; PEREIRA, Rosa Maria Rodrigues. Effect of a single high dose of vitamin D3 on hospital length of dtay in patients with moderate to severe COVID-19: a randomized clinical trial. Jama: Journal of the American Medical Association, [S.l.], v. 325, n. 11, p. 1053-1060, 16 mar. 2021. DOI: 10.1001/jama.2020.26848. Disponível em: https://jamanetwork.com/journals/jama/fullarticle/2776738. Acesso em: 19 fev. 2024. https://repositorio.ufrn.br/handle/123456789/57745 http://dx.doi.org/10.1001/jama.2020.26848 en JAMA: The Journal of the American Medical Association |