Vitamin D levels in COVID-19 patients [COVID-19}

  • Research type

    Research Study

  • Full title

    An observational study investigating the role of serum vitamin D levels in morbidity and mortality of patients diagnosed with COVID-19 in secondary care in the north-west of England

  • IRAS ID

    285337

  • Contact name

    Edward Jude

  • Contact email

    edward.jude@tgh.nhs.uk

  • Sponsor organisation

    Tameside and Glossop Integrated Care NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT04386044, clinicaltrials.gov

  • Duration of Study in the UK

    0 years, 2 months, 31 days

  • Research summary

    Research Summary:
    The 2019 novel coronavirus disease (COVID-2019) pandemic is an enormous health issue of worldwide scale. Prevention and/or treatment with a widely-available and already-licensed product such as vitamin D (cholecalciferol) could have a large impact on healthcare worldwide. Given ethnic variation in vitamin D production, this could help to address the discrepancies in how people of different ethnicities are affected by COVID-19. Furthermore, there are currently no published studies analysing individual-level evidence on the effect of vitamin D status on COVID-19 outcomes.The study will recruit patients hospitalised with COVID-19. Vitamin D levels will be measured in these patients and compared with outcome measures of COVID-19 severity. Data will be collected from a mixture of patient medical records, electronic patient records, laboratory data and from patients themselves. Data will be analysed with a combination of linear and logistic regression, as appropriate, and with adjustment for covariates.The primary objectives are to determine whether vitamin D levels affect outcomes in COVID-19 infection and whether vitamin D deficiency is associated with increased risk.

    Summary of Results:
    In conclusion, high-dose cholecalciferol booster therapy, regardless of baseline serum 25(OH)D levels, appears to be associated with a reduced risk of mortality in acute in-patients admitted with COVID-19. This suggests that further work should be carried out to determine what an adequate serum level of 25(OH)D might be from large-scale population studies, and paves the way for future clinical trials of cholecalciferol therapy, at multiple doses in order to assess maximum efficacy. This inexpensive and widely available treatment could have positive implications for the management of COVID-19 worldwide, particularly in developing nations.

  • REC name

    Wales REC 3

  • REC reference

    20/WA/0176

  • Date of REC Opinion

    23 Jun 2020

  • REC opinion

    Further Information Favourable Opinion