Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2020-06-01
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
Vitamin D
200,000 IU on admission
Placebo
Patients will receive an equivalent amount of a placebo solution on admission + conventional care
Placebo
200,000 IU on admission
Interventions
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Vitamin D
200,000 IU on admission
Placebo
200,000 IU on admission
Eligibility Criteria
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Inclusion Criteria
* Respiratory rate ≥ 24irpm and / or saturation \<93% in room air, or belonging to the risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary tuberculosis; 4. Obesity;
* Tomographic findings compatible with coronavirus disease.
Exclusion Criteria
* Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
* Prior vitamin D supplementation (above 1000 IU/day);
* Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
* Admitted patients with expected hospital discharge in less than 24 hours;
* Patient unable to sign the consent form.
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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ROSA MARIA RODRIGUES PEREIRA
Dr
Principal Investigators
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Rosa Pereira, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
School of Medicine, University of Sao Paulo
Bruno Gualano, PhD
Role: STUDY_DIRECTOR
School of Medicine, University of Sao Paulo
Locations
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Clinical Hospital of the School of Medicine, University of Sao Paulo
São Paulo, , Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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30959620.4.0000.0068
Identifier Type: -
Identifier Source: org_study_id