- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04449718
Vitamin D Supplementation in Patients With COVID-19
November 16, 2020 updated by: ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo
Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sao Paulo, Brazil, 05403-000
- Clinical Hospital of the School of Medicine, University of Sao Paulo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
|
200,000 IU on admission
|
Placebo Comparator: Placebo
Patients will receive an equivalent amount of a placebo solution on admission + conventional care
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200,000 IU on admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospitalization
Time Frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
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)
Time Frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
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
Time Frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
total number of days that patient remained in mechanic ventilator
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From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
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
|
From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
|
|
Inflammatory markers
Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
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
Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
serum concentration
|
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
Vitamin D
Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
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serum concentration
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Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
Creatinine
Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
serum concentration
|
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
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Calcium
Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
serum concentration
|
Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
|
Physical activity
Time Frame: Baseline
|
Baecke questionnaire (higher scores mean a higher physical activity level)
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Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rosa Pereira, PhD, MD, School of Medicine, University of Sao Paulo
- Study Director: Bruno Gualano, PhD, School of Medicine, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
October 7, 2020
Study Completion (Actual)
October 7, 2020
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 25, 2020
First Posted (Actual)
June 29, 2020
Study Record Updates
Last Update Posted (Actual)
November 17, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID Numbers
- 30959620.4.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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