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

    Fernandes, Alan L / Murai, Igor H / Reis, Bruna Z / Sales, Lucas P / Santos, Mayara D / Pinto, Ana J / Goessler, Karla F / Duran, Camila S C / Silva, Carla B R / Franco, André S / Macedo, Marina B / Dalmolin, Henrique H H / Baggio, Janaina / Balbi, Guilherme G M / Antonangelo, Leila / Caparbo, Valeria F / Gualano, Bruno / Pereira, Rosa M R

    The American journal of clinical nutrition

    2022  Volume 115, Issue 3, Page(s) 790–798

    Abstract: Background: The modulating effect of vitamin D on cytokine concentrations in severe coronavirus disease 2019 (COVID-19) remains unknown.: Objectives: We aimed to investigate the effect of a single high dose of vitamin D3 on cytokines, chemokines, and ...

    Abstract Background: The modulating effect of vitamin D on cytokine concentrations in severe coronavirus disease 2019 (COVID-19) remains unknown.
    Objectives: We 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.
    Methods: This 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.
    Results: The 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.
    Conclusions: The 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.
    MeSH term(s) Adult ; Aged ; Brazil ; COVID-19/immunology ; Chemokines/drug effects ; Cholecalciferol/administration & dosage ; Cytokines/drug effects ; Double-Blind Method ; Female ; Granulocyte-Macrophage Colony-Stimulating Factor/drug effects ; Humans ; Intercellular Signaling Peptides and Proteins/blood ; Male ; Middle Aged ; SARS-CoV-2/immunology ; Vascular Endothelial Growth Factor A/drug effects ; Vitamins/administration & dosage ; COVID-19 Drug Treatment
    Chemical Substances Chemokines ; Cytokines ; Intercellular Signaling Peptides and Proteins ; Vascular Endothelial Growth Factor A ; Vitamins ; Cholecalciferol (1C6V77QF41) ; Granulocyte-Macrophage Colony-Stimulating Factor (83869-56-1)
    Language English
    Publishing date 2022-01-12
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 280048-2
    ISSN 1938-3207 ; 0002-9165
    ISSN (online) 1938-3207
    ISSN 0002-9165
    DOI 10.1093/ajcn/nqab426
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Influence of vitamin D status on hospital length of stay and prognosis in hospitalized patients with moderate to severe COVID-19: a multicenter prospective cohort study.

    Reis, Bruna Z / Fernandes, Alan L / Sales, Lucas P / Santos, Mayara D / Dos Santos, Caroline C / Pinto, Ana J / Goessler, Karla F / Franco, Andre S / Duran, Camila S C / Silva, Carla B R / Macêdo, Marina B / Dalmolin, Henrique H H / Baggio, Janaína / Balbi, Guilherme G M / Antonangelo, Leila / Caparbo, Valeria F / Gualano, Bruno / Murai, Igor H / Pereira, Rosa M R

    The American journal of clinical nutrition

    2021  Volume 114, Issue 2, Page(s) 598–604

    Abstract: Background: Vitamin D acts as a mediator in the immune system regulating antiviral mechanisms and inflammatory processes. Vitamin D insufficiency has been suggested as a potential risk factor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV- ...

    Abstract Background: Vitamin D acts as a mediator in the immune system regulating antiviral mechanisms and inflammatory processes. Vitamin D insufficiency has been suggested as a potential risk factor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, although its impact on the prognosis of hospitalized patients with coronavirus disease 2019 (COVID-19) remains unclear.
    Objective: This multicenter prospective cohort study was designed to investigate whether serum 25-hydroxyvitamin D [25(OH)D] concentration is associated with hospital length of stay and prognosis in hospitalized patients with COVID-19.
    Methods: Patients with moderate to severe COVID-19 (n = 220) were recruited from 2 hospitals in Sao Paulo, Brazil. Serum 25(OH)D concentrations were categorized as follows: <10 ng/mL, 10 to <20 ng/mL, 20 to <30 ng/mL, and ≥30 ng/mL, and <10 ng/mL and ≥10 ng/mL. The primary outcome was hospital length of stay and the secondary outcomes were the rate of patients who required invasive mechanical ventilation and mortality.
    Results: There were no significant differences in hospital length of stay when the 4 25(OH)D categories were compared (P = 0.120). Patients exhibiting 25(OH)D <10 ng/mL showed a trend (P = 0.057) for longer hospital length of stay compared with those with 25(OH)D ≥10 ng/mL [9.0 d (95% CI: 6.4, 11.6 d) vs. 7.0 d (95% CI: 6.6, 7.4 d)]. The multivariable Cox proportional hazard models showed no significant associations between 25(OH)D and primary or secondary outcomes.
    Conclusions: Among hospitalized patients with moderate to severe COVID-19, those with severe 25(OH)D deficiency (<10 ng/mL) exhibited a trend for longer hospital length of stay compared with patients with higher 25(OH)D concentrations. This association was not significant in the multivariable Cox regression model. Prospective studies should test whether correcting severe 25(OH)D deficiency could improve the prognosis of patients with COVID-19.
    MeSH term(s) Adult ; Aged ; Brazil/epidemiology ; COVID-19/blood ; COVID-19/diagnosis ; COVID-19/mortality ; Female ; Hospital Mortality ; Hospitals ; Humans ; Length of Stay ; Male ; Middle Aged ; Prognosis ; Proportional Hazards Models ; Prospective Studies ; Respiration, Artificial ; SARS-CoV-2 ; Severity of Illness Index ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D Deficiency/blood ; Vitamin D Deficiency/complications ; Vitamins
    Chemical Substances Vitamins ; Vitamin D (1406-16-2) ; 25-hydroxyvitamin D (A288AR3C9H)
    Language English
    Publishing date 2021-05-24
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 280048-2
    ISSN 1938-3207 ; 0002-9165
    ISSN (online) 1938-3207
    ISSN 0002-9165
    DOI 10.1093/ajcn/nqab151
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  3. Article ; Online: Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial.

    Murai, Igor H / Fernandes, Alan L / Sales, Lucas P / Pinto, Ana J / Goessler, Karla F / Duran, Camila S C / Silva, Carla B R / Franco, André S / Macedo, Marina B / Dalmolin, Henrique H H / Baggio, Janaina / Balbi, Guilherme G M / Reis, Bruna Z / Antonangelo, Leila / Caparbo, Valeria F / Gualano, Bruno / Pereira, Rosa M R

    JAMA

    2021  Volume 325, Issue 11, Page(s) 1053–1060

    Abstract: Importance: The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear.: Objective: To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19.: Design, ... ...

    Abstract Importance: The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear.
    Objective: To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19.
    Design, setting, and participants: This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020.
    Interventions: Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 (n = 120) or placebo (n = 120).
    Main outcomes and measures: The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein.
    Results: Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P = .62). The difference between the vitamin D3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, -4.1% to 9.2%]; P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, -5.2% [95% CI, -15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference, -6.8% [95% CI, -15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events, but an episode of vomiting was associated with the intervention.
    Conclusions and relevance: Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19.
    Trial registration: ClinicalTrials.gov Identifier: NCT04449718.
    MeSH term(s) Adult ; Brazil ; COVID-19/drug therapy ; COVID-19/mortality ; COVID-19/therapy ; Cholecalciferol/administration & dosage ; Double-Blind Method ; Female ; Hospital Mortality ; Humans ; Intensive Care Units ; Length of Stay ; Male ; Middle Aged ; Respiration, Artificial ; Treatment Failure ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D Deficiency/drug therapy ; Vitamins/administration & dosage
    Chemical Substances Vitamins ; Vitamin D (1406-16-2) ; Cholecalciferol (1C6V77QF41) ; 25-hydroxyvitamin D (A288AR3C9H)
    Language English
    Publishing date 2021-02-17
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.26848
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Effect of Vitamin D3 Supplementation vs Placebo on Hospital Length of Stay in Patients with Severe COVID-19: A Multicenter, Double-blind, Randomized Controlled Trial.

    Murai, Igor H. / Fernandes, Alan L. / Sales, Lucas P. / Pinto, Ana J. / Goessler, Karla F. / Duran, Camila S. C. / Silva, Carla B. R. / Franco, Andre S. / Macedo, Marina B. / Dalmolin, Henrique H. H. / Baggio, Janaina / Balbi, Guilherme G. M. / Reis, Bruna Z. / Antonangelo, Leila / Caparbo, Valeria F. / Gualano, Bruno / Pereira, Rosa M. R.

    medRxiv

    Abstract: Importance: Patients with COVID-19 may exhibit 25-hydroxyvitamin D deficiency, but the beneficial effects of vitamin D3 supplementation in this disease remain to be proven by randomized controlled trials. Objective: To investigate the efficacy and safety ...

    Abstract Importance: Patients with COVID-19 may exhibit 25-hydroxyvitamin D deficiency, but the beneficial effects of vitamin D3 supplementation in this disease remain to be proven by randomized controlled trials. Objective: To investigate the efficacy and safety of vitamin D3 supplementation in patients with severe COVID-19. Design, Setting, and Participants: This is a multicenter, double-blind, randomized, placebo-controlled trial conducted in two centers (a quaternary hospital and a field hospital) in Sao Paulo, Brazil. The trial included 240 hospitalized patients with severe COVID-19. The study was conducted from June 2, 2020 to October 7, 2020. Interventions: Patients were randomly allocated (1:1 ratio) to receive either a single oral dose of 200,000 IU of vitamin D3 or placebo. Main Outcomes and Measures: The primary outcome was hospital length of stay, defined as hospital discharge from the date of randomization or death. Secondary outcomes were mortality, admission to ICU, mechanical ventilation requirement, and serum levels of 25-hydroxyvitamin D, creatinine, calcium, C-reactive protein, and D-dimer. Results: Of 240 randomized patients (mean age, 56 years; 56% men), 232 (96.7%) were included in the primary analysis. Log-rank test showed that hospital length of stay was comparable between the vitamin D3 supplementation and placebo groups (7.0 days [95% CI, 6.1 to 7.9] and 7.0 days [95% CI, 6.2 to 7.8 days]; hazard ratio, 1.12 [95% CI, 0.9 to 1.5]; P = .379; respectively). The rate of mortality (7.0% vs 5.1%; P = .590), admission to ICU (15.8% vs 21.2%; P = .314), and mechanical ventilation requirement (7.0% vs 14.4%; P = .090) did not significantly differ between groups. Vitamin D3 supplementation significantly increased serum 25-hydroxyvitamin D levels compared to placebo (difference, 24.0 ng/mL [95% CI, 21.0% to 26.9%]; P = .001). No adverse events were observed. Conclusions and Relevance: Among hospitalized patients with severe COVID-19, vitamin D3 supplementation was safe and increased 25-hydroxyvitamin D levels, but did not reduce hospital length of stay or any other relevant outcomes vs placebo. This trial does not support the use of vitamin D3 supplementation as an adjuvant treatment of patients with COVID-19.
    Keywords covid19
    Language English
    Publishing date 2020-11-17
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.11.16.20232397
    Database COVID19

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