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

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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.

• Document type: Journal article
• Source: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION; v. 325, n. 11, p. 8-pg., 2021-02-17.

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. (AU)

• FAPESP's process: 20/11102-2 - Vitamin D supplementation in patients with COVID-19: randomized, double-blind and placebo controlled clinical trial
• Grantee: Alan Lins Fernandes
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• FAPESP's process: 16/00006-7 - Evaluation of bone metabolism parameters by HR-pQCT and histomorphometry in rheumatoid arthritis and juvenile idiopathic arthritis patients: association with clinical and genetic variables
• Grantee: Eduardo Ferreira Borba Neto
• Support Opportunities: Research Projects - Thematic Grants
• FAPESP's process: 19/24782-4 - Comparison of mechanisms of bone loss in patients undergoing Roux-en-Y gastric bypass or sleeve gastrectomy
• Grantee: Igor Hisashi Murai
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• FAPESP's process: 15/26937-4 - Studies on physical (in)activity in patients with rheumatoid arthritis: characterization, associations with disease and effects of breaking up sedentary time
• Grantee: Ana Jéssica Pinto
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• FAPESP's process: 19/18039-7 - Reducing sedentary time in bariatric patients: a randomized controlled trial
• Grantee: Karla Fabiana Goessler
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• FAPESP's process: 20/05752-4 - Vitamin D supplementation in patients with COVID-19: randomized, double-blind and placebo controlled clinical trial
• Grantee: Rosa Maria Rodrigues Pereira
• Support Opportunities: Regular Research Grants
• FAPESP's process: 17/13552-2 - Reducing sedentary time in clinical populations: the take a stand for health study
• Grantee: Bruno Gualano
• Support Opportunities: Research Projects - Thematic Grants