Vitamin D supplementation in patients with COVID-19: randomized, double-blind, placebo-controlled clinical trial

  • Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Total publications:2 publications

Grant number: 20/05752-4

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2022
  • Funder

    Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Principal Investigator

    Rosa Maria Rodrigues Pereira
  • Research Location

    Brazil
  • Lead Research Institution

    Universidade de São Paulo
  • Research Priority Alignment

    N/A
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Clinical trials for disease management

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

100,000 IU on admission, followed by another 100,000 IU) after 5 days] or control (conventional treatment + placebo supplementation on the same days). Patients will be assessed for: 1) clinical and demographic characteristics (eg, sociodemographic data, comorbidities, medications for continuous use); 2) prognosis (eg, length of stay, number of cases admitted to Intensive Care Units, length of use of ventilators, number and severity of symptoms); 3) blood collection (eg, PCR for diagnosis of the virus and assessment of serum levels of 25-hydroxyvitamin D (25OHD), laboratory parameters included in the institutional guideline HC-FMUSP for the management of treatment of patients with COVID19 (eg PCR, D-dimer), calcium and creatinine (the last two, safety outcomes), on admission and on the day of discharge; 4) level of habitual physical activity (through a questionnaire). Demographic data and clinical characteristics of patients at the time of admission, as well as the patient's prognosis will be obtained through a specific questionnaire obtained from the HCFMUSP electronic medical record (Prontmed) or direct contact with family members and / or patients. Blood samples will be collected for laboratory analysis at the time of admission, and according to a routine hospital protocol. An aliquot will be stored for further analysis of 25OHD and biorepository, at the ward's hospitalization (day zero), day 7, day 14 and before discharge / death. The level of physical activity will be assessed only at the time of admission. This project has the potential to reveal, in an unprecedented way, whether vitamin D supplementation is safe and effective as an adjunctive treatment to COVID-19. In addition, the study will provide information, for the first time, about the influence of the level of physical activity on the prognosis of this disease. The findings may inform new clinical and public health measures to combat COVID-19 (AU) in an unprecedented way, if vitamin D supplementation is safe and effective as an adjuvant treatment to COVID-19. In addition, the study will provide information, for the first time, about the influence of the level of physical activity on the prognosis of this disease. The findings may inform new clinical and public health measures to combat COVID-19 (AU) in an unprecedented way, if vitamin D supplementation is safe and effective as an adjuvant treatment to COVID-19. In addition, the study will provide information, for the first time, about the influence of the level of physical activity on the prognosis of this disease. The findings may inform new clinical and public health measures to combat COVID-19 (AU)

Publicationslinked via Europe PMC

The severity of COVID-19 upon hospital admission is associated with plasma omega-3 fatty acids.

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.