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Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients will receive 200,000 IU of vitamin D3 on admission + conventional care |
|
| Placebo | Placebo Comparator | Patients will receive an equivalent amount of a placebo solution on admission + conventional care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 200,000 IU on admission |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | total number of days that patient remained hospitalized | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | number of patients that died | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month |
| Number of cases admitted to Intensive Care Unit (ICU) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Pereira, PhD, MD | School of Medicine, University of Sao Paulo | Principal Investigator |
| Bruno Gualano, PhD | School of Medicine, University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of the School of Medicine, University of Sao Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39208655 | Derived | Sales LP, Souza LVB, Fernandes AL, Murai IH, Santos MD, Vendramini MBG, Oliveira RM, Figueiredo CP, Caparbo VF, Gualano B, Pereira RMR; in memoriam. Effect of vitamin D3 on antiphospholipid antibodies in hospitalized patients with moderate to severe COVID-19. Clinics (Sao Paulo). 2024 Aug 27;79:100474. doi: 10.1016/j.clinsp.2024.100474. eCollection 2024. | |
| 38702342 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
200,000 IU on admission |
|
total number of days that patient remained in ICU
| From date of randomization until the date of hospital discharge or death, which is usually less than 1 month |
| Length of use of mechanic ventilator | total number of days that patient remained in mechanic ventilator | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month |
| Number and severity of symptoms | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month |
| Inflammatory markers | C-reactive protein, IL-1alpha (pg/ml), IL-1beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml), IL-1ra (pg/ml), IL-10 (pg/ml) concentration in the serum | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) |
| C-reactive protein | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) |
| Vitamin D | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) |
| Creatinine | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) |
| Calcium | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) |
| Physical activity | Baecke questionnaire (higher scores mean a higher physical activity level) | Baseline |
| Fernandes LP, Murai IH, Fernandes AL, Sales LP, Rogero MM, Gualano B, Barroso LP, Milne GL, Pereira RMR, Castro IA. The severity of COVID-19 upon hospital admission is associated with plasma omega-3 fatty acids. Sci Rep. 2024 May 3;14(1):10238. doi: 10.1038/s41598-024-60815-y. |
| 36176639 | Derived | Fernandes AL, Sales LP, Santos MD, Caparbo VF, Murai IH, Pereira RMR. Persistent or new symptoms 1 year after a single high dose of vitamin D3 in patients with moderate to severe COVID-19. Front Nutr. 2022 Sep 13;9:979667. doi: 10.3389/fnut.2022.979667. eCollection 2022. |
| 35020796 | Derived | Fernandes AL, Murai IH, Reis BZ, Sales LP, Santos MD, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. Effect of a single high dose of vitamin D3 on cytokines, chemokines, and growth factor in patients with moderate to severe COVID-19. Am J Clin Nutr. 2022 Mar 4;115(3):790-798. doi: 10.1093/ajcn/nqab426. |
| 34852148 | Derived | Murai IH, Fernandes AL, Antonangelo L, Gualano B, Pereira RMR. Effect of a Single High-Dose Vitamin D3 on the Length of Hospital Stay of Severely 25-Hydroxyvitamin D-Deficient Patients with COVID-19. Clinics (Sao Paulo). 2021 Nov 26;76:e3549. doi: 10.6061/clinics/2021/e3549. eCollection 2021. |
| 34029377 | Derived | Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043. |
| 33595634 | Derived | Murai IH, Fernandes AL, Sales LP, Pinto AJ, Goessler KF, Duran CSC, Silva CBR, Franco AS, Macedo MB, Dalmolin HHH, Baggio J, Balbi GGM, Reis BZ, Antonangelo L, Caparbo VF, Gualano B, Pereira RMR. 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. JAMA. 2021 Mar 16;325(11):1053-1060. doi: 10.1001/jama.2020.26848. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |