A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D—a randomised multicentre international clinical trial
Jorge B Cannata-Andía, Augusto Díaz-Sottolano, Pehuén Fernández, Carmen Palomo-Antequera, Pablo Herrero-Puente, Ricardo Mouzo, Natalia Carrillo-López, Sara Panizo, Guillermo H Ibañez, Carlos A Cusumano, Carolina Ballarino, Vicente Sánchez-Polo, Jacqueline Pefaur-Penna, Irene Maderuelo-Riesco, Jesús Calviño-Varela, Mónica D Gómez, Carlos Gómez-Alonso, John Cunningham, Manuel Naves-Díaz, Walter Douthat, José L Fernández-Martín
BMC Medicine, doi:10.1186/s12916-022-02290-8
Background: Vitamin D status has been implicated in COVID-19 disease. The objective of the COVID-VIT-D trial was to investigate if an oral bolus of cholecalciferol (100,000 IU) administered at hospital admission influences the outcomes of moderate-severe COVID-19 disease. In the same cohort, the association between baseline serum calcidiol levels with the same outcomes was also analysed.
Methods: The COVID-VIT-D is a multicentre, international, randomised, open label, clinical trial conducted throughout 1 year. Patients older than 18 years with moderate-severe COVID-19 disease requiring hospitalisation were included. At admission, patients were randomised 1:1 to receive a single oral bolus of cholecalciferol (n=274) or nothing (n=269). Patients were followed from admission to discharge or death. Length of hospitalisation, admission to intensive care unit (ICU) and mortality were assessed. Results: In the randomised trial, comorbidities, biomarkers, symptoms and drugs used did not differ between groups. Median serum calcidiol in the cholecalciferol and control groups were 17.0 vs. 16.1 ng/mL at admission and 29.0 vs. 16.4 ng/mL at discharge, respectively. The median length of hospitalisation (10.
Abbreviations AEMPs: Spanish Agency for Medicines and Health Products; BMI: Body mass index; CAT : Computed axial tomography; CRP: C-reactive protein; HUCA : Hospital Universitario Central de Asturias; ICU: Intensive care unit; IL-6: Interleukin 6; PCR: Polymerase chain reaction; SARS-CoV-2: Severe Acute Respiratory Syndrome CoronaVirus 2.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s12916-022-02290-8. S1 . Variables collected in the COVID-VIT-D trial. T. Table S2 . Symptoms at discharge. Table S3 . Biochemical parameters at discharge. Table S4 . Demographic, comorbidities, and serum calcidiol categories at hospital admission. Table S5 . Relevant biochemical parameters and serum calcidiol categories at hospital admission. Table S6 . Relevant biochemical parameters and serum calcidiol categories at hospital admission in age-matched patients. Table S7 . Pulmonary involvement at admission and outcomes according to serum calcidiol categories. Table S8 . Types and number of drugs received during the hospitalization and serum calcidiol categories at hospital admission. Table S9 . Demographic, comorbidities, and serum calcidiol categories at admission in agematched patients. Table S10 . Types and number of drugs received during the hospitalization and serum calcidiol categories at hospital admission in age-matched patients. Table S11 . Relevant biochemical parameters and serum calcidiol..
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' <jats:title>Background</jats:title>\n'
' <jats:p>Vitamin D status has been implicated in COVID-19 disease. The '
'objective of the COVID-VIT-D trial was to investigate if an oral bolus of cholecalciferol '
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' <jats:title>Methods</jats:title>\n'
' <jats:p>The COVID-VIT-D is a multicentre, international, randomised, open '
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' <jats:title>Results</jats:title>\n'
' <jats:p>In the randomised trial, comorbidities, biomarkers, symptoms and '
'drugs used did not differ between groups. Median serum calcidiol in the cholecalciferol and '
'control groups were 17.0 vs<jats:italic>.</jats:italic> 16.1 ng/mL at admission and 29.0 '
'vs<jats:italic>.</jats:italic> 16.4 ng/mL at discharge, respectively. The median length of '
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'pulmonary involvement and better outcomes.</jats:p>\n'
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' <jats:title>Conclusions</jats:title>\n'
' <jats:p>The randomised clinical trial showed the administration of an oral '
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'associated with outcomes.</jats:p>\n'
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{ 'value': 'The ethics committees of all participating centre approved the study. Due to '
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{ 'value': 'The following authors received research grants fees, grants for congress '
'attending, courses and collaborations by the following entities: Jorge B. '
'Cannata-Andía from Amgen, Kyowa-Kirim and Vifor Pharma; Ricardo Mouzo from '
'Takeda, Otsuka, Nipro, Sanofi-Aventis, Amgen and the Senefro Foundation; '
'Natalia Carrillo-López from Ministerio de Ciencia e Innovación '
'(MICINN)/Instituto de Salud Carlos III (ISCIII); Sara Panizo from MICINN/ISCIII '
'and Luis Hernando gran from Fundación Renal Íñigo Álvarez de Toledo; Carolina '
'Ballarino from Pfizer, Takeda and Sanofi-Aventis; Jacqueline Pefaur-Penna from '
'Novartis and Sanofi-Aventis; Jesús Calviño-Varela from Baxter, Otsuka, Palex, '
'Astra, Vifor and Chiesi; Carlos Gómez-Alonso from Amgen, UCB, Stada, '
'Grünenthal, Gebro Pharma, FAES, Kiowa-Kirin and Laboratorios Rubió; John '
'Cunningham from Amgen, Merck and Vifor Pharma; Manuel Naves-Díaz from '
'MICINN/ISCIII, Amgen, UCB, Kyowa-Kirim, Stada, Italfármaco, Gebro Pharma, '
'Rubió, Gedeon Richter, Grünenthal and FEIOMM and José L. Fernández-Martín from '
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