Please use this identifier to cite or link to this item:
https://observatorio.fm.usp.br/handle/OPI/39986
Title: | Effect of a Single High Dose of Vitamin D-3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19 A Randomized Clinical Trial |
Authors: | MURAI, Igor H.; FERNANDES, Alan L.; SALES, Lucas P.; PINTO, Ana J.; GOESSLER, Karla F.; DURAN, Camila S. C.; SILVA, Carla B. R.; FRANCO, Andre S.; MACEDO, Marina B.; DALMOLIN, Henrique H. H.; BAGGIO, Janaina; BALBI, Guilherme G. M.; REIS, Bruna Z.; ANTONANGELO, Leila; CAPARBO, Valeria F.; GUALANO, Bruno; PEREIRA, Rosa M. R. |
Citation: | JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, v.325, n.11, p.1053-1060, 2021 |
Abstract: | IMPORTANCE The efficacy of vitamin D-3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear. OBJECTIVE To investigate the effect of a single high dose of vitamin D-3 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 D-3 (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 D-3 (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 D-3 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 D-3 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 D-3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D-3 for treatment of moderate to severe COVID-19. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - COVID-19 Artigos e Materiais de Revistas Científicas - FM/MCM Artigos e Materiais de Revistas Científicas - FM/MPT Artigos e Materiais de Revistas Científicas - HC/ICHC Artigos e Materiais de Revistas Científicas - LIM/03 Artigos e Materiais de Revistas Científicas - LIM/17 Artigos e Materiais de Revistas Científicas - ODS/03 |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
art_MURAI_Effect_of_a_Single_High_Dose_of_Vitamin_2021.PDF Restricted Access | publishedVersion (English) | 404.03 kB | Adobe PDF | View/Open Request a copy |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.