High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: Multicentre randomized controlled clinical trial
PLoS ONE 17(5): e0267918. https://doi.org/10.1371/iournal. pone.0267918
Javier MarianinD1’2*, Laura AntoniettinD1’2, Carlos Tajer1,2, Leon Ferder3, Felipe InserranD3, Milagro Sanchez Cunto4, Diego Brosio5, Fernando Ross6, Marcelo Zylberman7, Daniel Emilio Lopez8, Cecilia Luna Hisano9, Sebastián Maristany Batisda1, Gabriela Pace10, Adrian Salvatore11, Jimena Fernanda Hogrefe12, Marcela Turela13, Andres Gaido14, Beatriz Rodera15, Elizabeth Banega16, Maria Eugenia Iglesias17, Mariela Rzepeski18, Juan Manuel Gomez Portillon?19, Magali Bertelli4, Andrés Vilela6, Leandro Heffner7, Veronica Laura Annetta5, Lucila Moracho4, Maximiliano Carmona11, Graciela Melito3, Maria Jose Martinez1, Gloria Luna1, Natalia Vensentini1, Walter Manucha20
The role of oral vitamin D3 supplementation for hospitalized patients with COVID-19 remains to be determined. The study was aimed to evaluate whether vitamin D3 supplementation could prevent respiratory worsening among hospitalized patients with COVID-19.
Methods and findings
We designed a multicentre, randomized, double-blind, sequential, placebo-controlled clinical trial. The study was conducted in 17 second and third level hospitals, located in four provinces of Argentina, from 14 August 2020 to 22 June 2021. We enrolled 218 adult patients, hospitalized in general wards with SARS-CoV-2 confirmed infection, mild-to-mod- erate COVID-19 and risk factors for disease progression. Participants were randomized to a single oral dose of 500 000 IU of vitamin D3 or matching placebo. Randomization ratio was 1:1, with permuted blocks and stratified for study site, diabetes and age (<60 vs >60 years). The primary outcome was the change in the respiratory Sepsis related Organ Failure Assessment score between baseline and the highest value recorded up to day 7. Secondary outcomes included the length of hospital stay; intensive care unit admission; and in-hospital mortality. Overall, 115 participants were assigned to vitamin D3 and 105 to placebo (mean [SD] age, 59.1 [10.7] years; 103 [47.2%] women). There were no significant differences in the primary outcome between groups (median [IQR] 0.0 [0.0-1.0] vs 0.0 [0.0-1.0], for vitamin D3and placebo, respectively; p = 0.925). Median [IQR] length of hospital stay was not significantly different between vitamin D3 group (6.0 [4.0-9.0] days) and placebo group (6.0 [4.0-10.0] days; p = 0.632). There were no significant differences for intensive care unit admissions (7.8% vs 10.7%; RR 0.73; 95% CI 0.32 to 1.70; p = 0.622), or in-hospital mortality (4.3% vs 1.9%; RR 2.24; 95% CI 0.44 to 11.29; p = 0.451). There were no significant differences in serious adverse events (vitamin D3 = 14.8%, placebo = 11.7%).
Among hospitalized patients with mild-to-moderate COVID-19 and risk factors, a single high oral dose of vitamin D3 as compared with placebo, did not prevent the respiratory worsening.
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"Median time from onset of the symptoms to admission was 7.0 (IQR 5.0 to 10.0) days,..."
Early COVID treatments must be made within a few days of symptoms
For ALL types of treatment, not just Vitamin D