Evidence map›Paper›PMID 35622854›Full record

Trial reportPloS one2022

High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: Multicentre randomized controlled clinical trial.

Javier Mariani, Laura Antonietti, Carlos Tajer, León Ferder, Felipe Inserra, Milagro Sanchez Cunto, Diego Brosio, Fernando Ross, Marcelo Zylberman, Daniel Emilio López and 23 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04411446 (Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients), which is not on this map. Cited by 38 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 14 pooled it
9.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04411446 phase4completednot on this map

Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients

TypeinterventionalSponsorVitamin D Study GroupRan2020 to 2021Enrolled218ConditionsCOVIDArmsVitamin D, Placebo
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 14 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors at 14 institutions in 1 country.

Javier MarianiHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.ORCID 0000-0002-9372-6817
Laura AntoniettiHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.ORCID 0000-0002-7676-4264
Carlos TajerHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.
León FerderMaimónides University, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Felipe InserraMaimónides University, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.ORCID 0000-0002-6671-874X
Milagro Sanchez CuntoHospital de Infecciosas Francisco Javier Muñiz, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Diego BrosioHospital General de Agudos Dr. Enrique Tornú, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Fernando RossClínica Santa Isabel, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Marcelo ZylbermanHospital General de Agudos Dr. Cosme Argerich, Ciudad Autónoma de Buenos Aires, Argentina.
Daniel Emilio LópezHospital General de Agudos Dr. Teodoro Álvarez, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Cecilia Luna HisanoHospital General de Agudos Dr. Juan A. Fernández, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Sebastián Maristany BatisdaHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.
Gabriela PaceHospital General de Agudos Parmenio Piñero, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Adrián SalvatoreHospital Luis Lagomaggiore, Mendoza, Argentina.
Jimena Fernanda HogrefeSanatorio Güemes, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Marcela TurelaHospital Regional Antonio J. Scaravelli, Tunuyán, Mendoza, Argentina.
Andrés GaidoSanatorio Allende, Sede Cerro, Córdoba, Argentina.
Beatriz RoderaHospital Zonal General de Agudos "Dr. Isidoro Iriarte", Quilmes, Buenos Aires, Argentina.
Elizabeth BanegaHospital Interzonal Especializado en Agudos y Crónicos, Neuropsiquiátrico Dr. Alejandro Korn, Melchor Romero, Buenos Aires, Argentina.
María Eugenia IglesiasSanatorio Allende Nueva Córdoba, Córdoba, Argentina.
Mariela RzepeskiHospital Modular de Florencio Varela, Florencio Varela, Buenos Aires, Argentina.
Juan Manuel Gomez PortilloHospital El Carmen, Godoy Cruz, Mendoza, Argentina.ORCID 0000-0001-9615-3746
Magalí BertelliHospital de Infecciosas Francisco Javier Muñiz, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Andrés VilelaClínica Santa Isabel, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Leandro HeffnerHospital General de Agudos Dr. Cosme Argerich, Ciudad Autónoma de Buenos Aires, Argentina.
Verónica Laura AnnettaHospital General de Agudos Dr. Enrique Tornú, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Lucila MorachoHospital de Infecciosas Francisco Javier Muñiz, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
Maximiliano CarmonaHospital Luis Lagomaggiore, Mendoza, Argentina.
Graciela MelitoMaimónides University, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina.
María José MartínezHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.
Gloria LunaHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.
Natalia VensentiniHospital de Alta Complejidad en Red El Cruce-Néstor Kirchner, Florencio Varela, Buenos Aires, Argentina.
Walter ManuchaConsejo Nacional de Investigaciones Científicas y Técnicas, Universidad Nacional de Cuyo, Instituto de Medicina y Biología Experimental de Cuyo (IMBECU), Mendoza, Argentina.
Hospital El Cruce · ARHospital Muñiz · ARUniversidad Maimónides · ARUniversidad Nacional Arturo Jauretche · ARUniversity of Mendoza · ARArgerich Hospital · AREl Hospital General de Agudos Carlos G. Durand · ARFundacion Allende · ARDr. Lucio Meléndez Hospital Zonal General de Agudos · ARHelios Salud · ARHospital Fernández · ARHospital General de Agudos Dr. TEODORO ALVAREZ · ARHospital Piñero · ARUniversidad Nacional de Cuyo · AR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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

findingsWe 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-moderate 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 D3 and 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%).

conclusionsAmong 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.

trial registrationClincicalTrials.gov Identifier: NCT04411446.

Indexed as

COVID-19 Drug TreatmentVitamin DAdultCholecalciferolFemaleHumansMaleMiddle AgedSARS-CoV-2VitaminsCholecalciferolVitamin DVitamins

Identifiers

PMID35622854
PMCPMC9140264
OpenAlexW4281654537

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.