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
RCT 274 very late stage (>80% pulmonary involvement at baseline) hospitalized COVID-19 patients treated with a single dose of cholecalciferol, and 269 control patients, showing no significant differences. High serum calcidiol levels at admission were associated with lower pulmonary involvement, shorter hospitalization, and lower ICU admission.
Serum levels increased in the treatment group, however average levels were still insufficient at discharge. Calcifediol or calcitriol, which avoids several days delay in conversion, may be more successful, especially with this very late stage usage.
100,000IU cholecalciferol.
This study is excluded in the after exclusion results of meta
analysis:
very late stage study using cholecalciferol instead of calcifediol or calcitriol.
risk of death, 44.0% higher, RR 1.44, p = 0.31, treatment 22 of 274 (8.0%), control 15 of 269 (5.6%).
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risk of ICU admission, 4.9% higher, RR 1.05, p = 0.82, treatment 47 of 274 (17.2%), control 44 of 269 (16.4%).
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hospitalization time, 5.3% higher, relative time 1.05, treatment 274, control 269.
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risk of death, 117.0% higher, RR 2.17, p = 0.20, high D levels 87, low D levels 96, >25 vs. ≤10 ng/mL, adjusted by demographics, comorbidities, and laboratory parameters, outcome based on serum levels.
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risk of ICU admission, 65.0% lower, RR 0.35, p = 0.04, high D levels 87, low D levels 96, >25 vs. ≤10 ng/mL, adjusted by demographics, comorbidities, and laboratory parameters, outcome based on serum levels.
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risk of progression, 79.0% lower, RR 0.21, p = 0.003, high D levels 87, low D levels 96, pulmonary involvment at admission, >25 vs. ≤10 ng/mL, adjusted by demographics, comorbidities, and laboratory parameters, outcome based on serum levels.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Cannata-Andía et al., 18 Feb 2022, Randomized Controlled Trial, multiple countries, peer-reviewed, median age 59.0, 22 authors, dosage 100,000IU single dose, trial
NCT04552951 (history) (COVID-VIT-D).
Abstract: (2022) 20:83
Cannata‑Andía et al. BMC Medicine
https://doi.org/10.1186/s12916-022-02290-8
RESEARCH ARTICLE
Open Access
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‑Andía1,2,3,4*† , Augusto Díaz‑Sottolano2,5†, Pehuén Fernández6,7,8†,
Carmen Palomo‑Antequera1,2,3, Pablo Herrero‑Puente1,2,3, Ricardo Mouzo9, Natalia Carrillo‑López1,2,4,
Sara Panizo1,2,4, Guillermo H. Ibañez10, Carlos A. Cusumano11, Carolina Ballarino12, Vicente Sánchez‑Polo13,
Jacqueline Pefaur‑Penna14,15, Irene Maderuelo‑Riesco16, Jesús Calviño‑Varela17, Mónica D. Gómez18,
Carlos Gómez‑Alonso1,2,3,4, John Cunningham19, Manuel Naves‑Díaz1,2,4*†, Walter Douthat6,7,8†,
José L. Fernández‑Martín1,2,4† and the COVID-VIT-D trial collaborators
Abstract
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 out‑
comes 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 through‑
out 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 noth‑
ing (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 (10.0 [95%CI 9.0–10.5] vs. 9.5
*Correspondence: cannata@hca.es; jorge.cannata@gmail.com; mnaves.
huca@gmail.com
†
Augusto Díaz-Sottolano and Pehuén Fernández are second authors.
†
Walter Douthat and José L. Fernández-Martín are senior authors (two last
authors).
†
Jorge B. Cannata-Andía and Manuel Naves-Díaz contributed equally to
this work as corresponding authors.
1
Hospital Universitario Central de Asturias (HUCA), Avda. Roma s/n.,
33011 Oviedo, Spain
Full list of author information is available at the end of the article
© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
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to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
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