Evidence map›Paper›PMID 40818016›Full record

Trial reportClinical rheumatology2025

High- vs. routine-dose vitamin D3 in severe lupus on pulse methylprednisolone: a randomized, double-blind, placebo-controlled clinical trial.

Lisbeth A Aguila, Rosa M R Pereira, Luciana P Seguro, Michelle R Ugolini-Lopes, Lissiane K N Guedes, Lucas P Sales, Alan L Fernandes, Felipe M de Santana, Valéria F Caparbo, Liliam Takayama and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

12 authors.

Lisbeth A AguilaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Rosa M R PereiraRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Luciana P SeguroRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Michelle R Ugolini-LopesRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Lissiane K N GuedesRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Lucas P SalesBone Mineral Metabolism Laboratory, Rheumatology Division, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 01246-903, Brazil.
Alan L FernandesBone Mineral Metabolism Laboratory, Rheumatology Division, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 01246-903, Brazil.
Felipe M de SantanaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Valéria F CaparboBone Mineral Metabolism Laboratory, Rheumatology Division, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 01246-903, Brazil.
Liliam TakayamaBone Mineral Metabolism Laboratory, Rheumatology Division, Faculdade de Medicina, Universidade de São Paulo, São Paulo, 01246-903, Brazil.
Eduardo F Borba *Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil.
Diogo S Domiciano *Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av Dr Arnaldo, 455 - Reumatologia, 3O Andar, Sala 3193, Cerqueira César, São Paulo, Brazil. dsdomiciano@hotmail.com.ORCID http://orcid.org/0000-0001-7991-0231

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION/

objectivesThis study evaluated high- vs. routine-dose vitamin D3 in severe SLE patients on high-dose glucocorticoids, an underrepresented group in research.

methodsIn a randomized, double-blind, placebo-controlled trial, 40 SLE inpatients receiving intravenous pulse methylprednisolone were assigned to "high-dose" (HD) (100,000 IU of vitamin D3 plus 7000 IU weekly, n = 20) or "routine-dose" (RD) vitamin D3 group (placebo plus 7000 IU weekly, n = 20) for 24 weeks. Changes in disease activity were assessed from baseline to study end.

resultsBaseline SLEDAI scores were comparable between the HD group (median 19) and the RD group (median 14.5; p = 0.230). After 24 weeks, the HD group had a significantly greater increase in 25OHD concentrations (median 15.4 ng/ml) compared to the RD group (median 8.0 ng/ml; p = 0.028). No difference in SLEDAI scores was observed; however, there was a trend toward a greater ΔC4 increase in the HD group (7.38 vs. 3.27, p = 0.093). Δ25OHD showed positive correlations with disease activity markers. ROC analysis identified Δ25OHD cutoffs of 12.9 ng/ml (AUC = 0.741) for C3 and 11.7 ng/ml (AUC = 0.757) for C4 normalization, indicating that exceeding these may improve complement normalization.

conclusionsAlthough SLEDAI scores did not differ between groups, high-dose vitamin D

Indexed as

CholecalciferolGlucocorticoidsLupus Erythematosus, SystemicMethylprednisoloneAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeVitamin DYoung Adult25-hydroxyvitamin DCholecalciferolGlucocorticoidsMethylprednisoloneVitamin DDisease activityHigh doseSerum 25OHDSystemic lupus erythematosusVitamin D3 supplementation

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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.