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Vitamin D Supplementation in Patients With COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, vitamin D, acute respiratory syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Length of hospitalization
total number of days that patient remained hospitalized

Secondary Outcome Measures

Mortality
number of patients that died
Number of cases admitted to Intensive Care Unit (ICU)
total number of days that patient remained in ICU
Length of use of mechanic ventilator
total number of days that patient remained in mechanic ventilator
Number and severity of symptoms
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
C-reactive protein
serum concentration
Vitamin D
serum concentration
Creatinine
serum concentration
Calcium
serum concentration
Physical activity
Baecke questionnaire (higher scores mean a higher physical activity level)

Full Information

First Posted
June 16, 2020
Last Updated
November 16, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04449718
Brief Title
Vitamin D Supplementation in Patients With COVID-19
Official Title
Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, vitamin D, acute respiratory syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive an equivalent amount of a placebo solution on admission + conventional care
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
200,000 IU on admission
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
200,000 IU on admission
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
total number of days that patient remained hospitalized
Time Frame
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Secondary Outcome Measure Information:
Title
Mortality
Description
number of patients that died
Time Frame
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Title
Number of cases admitted to Intensive Care Unit (ICU)
Description
total number of days that patient remained in ICU
Time Frame
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Title
Length of use of mechanic ventilator
Description
total number of days that patient remained in mechanic ventilator
Time Frame
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Title
Number and severity of symptoms
Time Frame
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
Title
Inflammatory markers
Description
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
Time Frame
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Title
C-reactive protein
Description
serum concentration
Time Frame
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Title
Vitamin D
Description
serum concentration
Time Frame
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Title
Creatinine
Description
serum concentration
Time Frame
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Title
Calcium
Description
serum concentration
Time Frame
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
Title
Physical activity
Description
Baecke questionnaire (higher scores mean a higher physical activity level)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Pereira, PhD, MD
Organizational Affiliation
School of Medicine, University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
Organizational Affiliation
School of Medicine, University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of the School of Medicine, University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36176639
Citation
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.
Results Reference
derived
PubMed Identifier
35020796
Citation
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.
Results Reference
derived
PubMed Identifier
34852148
Citation
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.
Results Reference
derived
PubMed Identifier
34029377
Citation
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.
Results Reference
derived
PubMed Identifier
33595634
Citation
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.
Results Reference
derived

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Vitamin D Supplementation in Patients With COVID-19

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