Evidence map›Paper›PMID 35020796›Full record

Trial reportThe American journal of clinical nutrition2022

Effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in patients with moderate to severe COVID-19.

Alan L Fernandes, Igor H Murai, Bruna Z Reis, Lucas P Sales, Mayara D Santos, Ana J Pinto, Karla F Goessler, Camila S C Duran, Carla B R Silva, André S Franco and 8 more

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

Trial report in The American journal of clinical nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04449718 (Vitamin D Supplementation in Patients With COVID-19), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
6.3field-weighted citation impact, top 2% 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.

NCT04449718 nacompletednot on this map

Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorUniversity of Sao PauloRan2020 to 2020Enrolled240ConditionsCOVID-19ArmsVitamin D, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 43 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

18 authors at 2 institutions in 1 country.

Alan L FernandesRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-6786-3922
Igor H MuraiRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-0077-5004
Bruna Z ReisRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-8726-8699
Lucas P SalesRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Mayara D SantosRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Ana J PintoApplied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Karla F GoesslerApplied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Camila S C DuranRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Carla B R SilvaRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
André S FrancoRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Marina B MacedoRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Henrique H H DalmolinRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Janaina BaggioRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Guilherme G M BalbiRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Leila AntonangeloClinical Pathology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da Universidade de Sao Paulo,, Sao Paulo, Brazil.
Valeria F CaparboRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Bruno GualanoApplied Physiology & Nutrition Research Group, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0001-7100-8681
Rosa M R PereiraRheumatology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.ORCID 0000-0002-3723-5028
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRUniversidade de São Paulo · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 305556/2017-7Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/11102-2
6 · The paper itself

Abstract

backgroundThe modulating effect of vitamin D on cytokine concentrations in severe coronavirus disease 2019 (COVID-19) remains unknown.

objectivesWe aimed to investigate the effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in hospitalized patients with moderate to severe COVID-19.

methodsThis is a post hoc, ancillary, and exploratory analysis from a multicenter, double-blind, placebo-controlled, randomized clinical trial. Patients with moderate to severe COVID-19 were recruited from 2 hospitals in São Paulo, Brazil. Of 240 randomly assigned patients, 200 were assessed in this study and randomly assigned to receive a single oral dose of 200,000 IU vitamin D3 (n = 101) or placebo (n = 99). The primary outcome was hospital length of stay, which has been published in our previous study. The prespecified secondary outcomes were serum concentrations of IL-1β, IL-6, IL-10, TNF-α, and 25-hydroxyvitamin D. The post hoc exploratory secondary outcomes were IL-4, IL-12p70, IL-17A, IFN-γ, granulocyte-macrophage colony-stimulating factor (GM-CSF), IL-8, IFN-inducible protein-10 (IP-10), macrophage inflammatory protein-1β (MIP-1β), monocyte chemoattractant protein-1 (MCP-1), vascular endothelial growth factor (VEGF), and leukocyte count. Generalized estimating equations for repeated measures, with Bonferroni's adjustment, were used for testing all outcomes.

resultsThe study included 200 patients with a mean ± SD age of 55.5 ± 14.3 y and BMI of 32.2 ± 7.1 kg/m2, of which 109 (54.5%) were male. GM-CSF concentrations showed a significant group-by-time interaction effect (P = 0.04), although the between-group difference at postintervention after Bonferroni's adjustment was not significant. No significant effects were observed for the other outcomes.

conclusionsThe findings do not support the use of a single dose of 200,000 IU vitamin D3, compared with placebo, for the improvement of cytokines, chemokines, and growth factor in hospitalized patients with moderate to severe COVID-19.This trial was registered at clinicaltrials.gov as NCT04449718.

Indexed as

COVID-19 Drug TreatmentAdultAgedBrazilChemokinesCholecalciferolCOVID-19CytokinesDouble-Blind MethodFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansIntercellular Signaling Peptides and ProteinsMaleMiddle AgedSARS-CoV-2ChemokinesCholecalciferolCytokinesGranulocyte-Macrophage Colony-Stimulating FactorIntercellular Signaling Peptides and ProteinsVascular Endothelial Growth Factor AVitaminsacute-phase reactantsimmune responseinflammationSARS-CoV-2vitamin D

Identifiers

PMID35020796
PMCPMC8807215
OpenAlexW4206635822

What OpenQuestion holds

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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.