Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial
Murai IH, Fernandes AL, Sales LP, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Reis BZ, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR
JAMA · 372 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Gobierno
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Subvenciones
- Fundação de Amparo à Pesquisa do Estado de São Paulo (20/05752-4)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2021-02-20 · JAMA · vol. 325 · número 11 · pág. 1053
- Editorial
- American Medical Association
- Citado
- 530 citas · más que el 100% de estudios similares · 70.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 25 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · COVID-19 Clinical Research Studies · Vitamin C and Antioxidants Research
- Palabras clave
- Medicine, Interquartile range, Vitamin D and neurology, Mechanical ventilation, Coronavirus disease 2019 (COVID-19), Intensive care unit, Randomized controlled trial, Placebo, Randomization, Internal medicine, Pediatrics, Disease
- MeSH
- humans, vitamin d deficiency, cholecalciferol, vitamins, vitamin d, treatment failure, respiration, artificial, length of stay, hospital mortality, double-blind method, adult, middle aged, intensive care units, brazil, female, male, covid-19, covid-19 drug treatment
17 autores
- Igor Hisashi Murai🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Alan Lins Fernandes🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Lucas Peixoto Sales🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Ana Jéssica Pinto🇧🇷Universidade de São Paulo
- Karla Fabiana Goessler🇧🇷Universidade de São Paulo
- Camila SC Duran🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Carla B. R. Silva🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- André Silva Franco🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Marina Barguil Macêdo🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Henrique H. H. Dalmolin🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Janaína Baggio🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Guilherme G. M. Balbi🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Bruna Zavarize Reis🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Leila Antonângelo🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Valéria F. Caparbo🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Bruno Gualano🇧🇷Universidade de São Paulo
- Rosa Maria Rodrigues Pereira🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Trial registration
ClinicalTrials.gov Identifier: NCT04449718.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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