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Vitamin D Supplementation in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449718
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Vitamin D Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Experimental
Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
Dietary Supplement: Vitamin D
200,000 IU on admission

Placebo Comparator: Placebo
Patients will receive an equivalent amount of a placebo solution on admission + conventional care
Dietary Supplement: Placebo
200,000 IU on admission




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 ]
  5. 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

  6. 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

  7. Vitamin D [ Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) ]
    serum concentration

  8. Creatinine [ Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) ]
    serum concentration

  9. Calcium [ Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) ]
    serum concentration

  10. Physical activity [ Time Frame: Baseline ]
    Baecke questionnaire (higher scores mean a higher physical activity level)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449718


Contacts
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Contact: Rosa Pereira, PhD, MD +55 (11) 3061-7490 rosamariarp@yahoo.com

Locations
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Brazil
Clinical Hospital of the School of Medicine, University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Rosa Pereira, PhD, MD    +55 (11) 3061-8594    rosamariarp@yahoo.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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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
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Responsible Party: ROSA MARIA RODRIGUES PEREIRA, Dr, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04449718    
Other Study ID Numbers: 30959620.4.0000.0068
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo:
COVID-19
vitamin D
acute respiratory syndrome
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents