Vitamin D Supplementation in Patients With COVID-19

NCT04449718 | Completed

• 1 other identifier: 30959620.4.0000.0068
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; vitamin D; acute respiratory syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Mortality

  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)

  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

  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

  Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)

Study Arms (2)

Experimental

EXPERIMENTAL

Patients will receive 200,000 IU of vitamin D3 on admission + conventional care

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Patients will receive an equivalent amount of a placebo solution on admission + conventional care

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

200,000 IU on admission

Experimental

Placebo DIETARY_SUPPLEMENT

200,000 IU on admission

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of flu syndrome with hospitalization 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.

You may not qualify if:

• Patient admitted already under invasive mechanical ventilation;
• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, 05403-000, Brazil

Location

Related Publications (7)

• 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.

  PMID: 39208655 DERIVED

• 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.

  PMID: 38702342 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.

  PMID: 36176639 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.

  PMID: 35020796 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.

  PMID: 34852148 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.

  PMID: 34029377 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.

  PMID: 33595634 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 29, 2020
• Study Start: June 1, 2020
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)