Research paper
High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: Multicentre randomized controlled clinical trial
- J. Mariani
- Laura Antonietti
- C. Tajer
- L. Ferder
- F. Inserra
- Milagro Sanchez Cunto
- D. Brosio
- F. Ross
- M. Zylberman
- Daniel Emilio López
- Cecilia Luna Hisano
- Sebastián Maristany Batisda
- Gabriela Pace
- Adrián Salvatore
- J. Hogrefe
- Marcela Turela
- Andrés Gaido
- B. Rodera
- Elizabeth Banega
- M. Iglesias
- Mariela Rzepeski
- Juan Manuel Gomez Portillo
- Magalí Bertelli
- Andrés Vilela
- L. Heffner
- V. Annetta
- Lucila Moracho
- Maximiliano Carmona
- Graciela Melito
- M. Martínez
- G. Luna
- Natalia Vensentini
- W. Manucha
Study answer
What this study found
High-dose vitamin D3 did not prevent respiratory deterioration or improve clinical outcomes compared with placebo. The primary outcome, change in rSOFA from baseline to day 7, was 0.0 (0.0-1.0) in both groups, with a between-group difference of 0.00 (-0.18 to 0.15; p = 0.825). Other key outcomes were also null, including change in SpO2 (-1.0 vs -1.0; p = 0.952), length of stay (6.0 vs 6.0 days; p = 0.632), ICU admission (7.8% vs 10.7%; RR 0.73, 0.32 to 1.70; p = 0.622), and in-hospital death (4.3% vs 1.9%; RR 2.24, 0.44 to 11.29; p = 0.451). Serious adverse events occurred in 14.8% of the…
- Study & population
- Multicentre randomized controlled clinical trial conducted in 17 hospitals in four provinces of Argentina from August 2020 to June 2021.
- Intervention
- Participants in the active arm received a single oral dose of vitamin D3 500,000 IU as five 100,000 IU soft gel capsules, administered as soon as possible after randomization, versus matching placebo.
- Key limitation
- The trial tested only a single very high dose, so it does not address repeated dosing or other regimens.
Original abstract
Background 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 patient…