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-19Start & end year
20202022Funder
Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)Principal Investigator
Rosa Maria Rodrigues PereiraResearch Location
BrazilLead Research Institution
Universidade de São PauloResearch 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)
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