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Trial record 1 of 1 for:    NCT04449718
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Vitamin D Supplementation in Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04449718
Recruitment Status : Completed
First Posted : June 29, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE June 16, 2020
First Posted Date  ICMJE June 29, 2020
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE June 1, 2020
Actual Primary Completion Date October 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • 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
  • 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
  • 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
  • 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 ]
  • 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
  • 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
  • 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
  • Creatinine [ Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) ]
    serum concentration
  • Calcium [ Time Frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) ]
    serum concentration
  • Physical activity [ Time Frame: Baseline ]
    Baecke questionnaire (higher scores mean a higher physical activity level)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Patients With COVID-19
Official Title  ICMJE Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Dietary Supplement: Vitamin D
    200,000 IU on admission
  • Dietary Supplement: Placebo
    200,000 IU on admission
Study Arms  ICMJE
  • Experimental: Experimental
    Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Patients will receive an equivalent amount of a placebo solution on admission + conventional care
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2020)
240
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2020)
200
Actual Study Completion Date  ICMJE October 7, 2020
Actual Primary Completion Date October 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04449718
Other Study ID Numbers  ICMJE 30959620.4.0000.0068
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ROSA MARIA RODRIGUES PEREIRA, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP