<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449718</url>
  </required_header>
  <id_info>
    <org_study_id>30959620.4.0000.0068</org_study_id>
    <nct_id>NCT04449718</nct_id>
  </id_info>
  <brief_title>Vitamin D Supplementation in Patients With COVID-19</brief_title>
  <official_title>Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the&#xD;
      World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical&#xD;
      and scientific community have sought alternatives to treat infected individuals, as well as&#xD;
      identifying risk or protective factors for the contamination and prognosis of patients. In&#xD;
      this perspective, vitamin D supplementation can improve some important outcomes in critically&#xD;
      ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a&#xD;
      common outcome in critically ill patients, thus making it a modifiable risk factor with great&#xD;
      potential for reducing hospital stay and intensive care and mortality. The investigators&#xD;
      speculate that vitamin D supplementation could have therapeutic effects in patients with&#xD;
      COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">October 7, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>From date of randomization until the date of hospital discharge or death, which is usually less than 1 month</time_frame>
    <description>total number of days that patient remained hospitalized</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From date of randomization until the date of hospital discharge or death, which is usually less than 1 month</time_frame>
    <description>number of patients that died</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases admitted to Intensive Care Unit (ICU)</measure>
    <time_frame>From date of randomization until the date of hospital discharge or death, which is usually less than 1 month</time_frame>
    <description>total number of days that patient remained in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of use of mechanic ventilator</measure>
    <time_frame>From date of randomization until the date of hospital discharge or death, which is usually less than 1 month</time_frame>
    <description>total number of days that patient remained in mechanic ventilator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and severity of symptoms</measure>
    <time_frame>From date of randomization until the date of hospital discharge or death, which is usually less than 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers</measure>
    <time_frame>Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)</time_frame>
    <description>serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)</time_frame>
    <description>serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)</time_frame>
    <description>serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium</measure>
    <time_frame>Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)</time_frame>
    <description>serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Baseline</time_frame>
    <description>Baecke questionnaire (higher scores mean a higher physical activity level)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 200,000 IU of vitamin D3 on admission + conventional care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive an equivalent amount of a placebo solution on admission + conventional care</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>200,000 IU on admission</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>200,000 IU on admission</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of flu syndrome with hospitalization criteria;&#xD;
&#xD;
          -  Respiratory rate ≥ 24irpm and / or saturation &lt;93% in room air, or belonging to the&#xD;
             risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus,&#xD;
             systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary&#xD;
             tuberculosis; 4. Obesity;&#xD;
&#xD;
          -  Tomographic findings compatible with coronavirus disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient admitted already under invasive mechanical ventilation;&#xD;
&#xD;
          -  Patient admitted with severe acute respiratory syndrome and diagnosed with an&#xD;
             etiologic agent other than SARS-CoV-2;&#xD;
&#xD;
          -  Prior vitamin D supplementation (above 1000 IU/day);&#xD;
&#xD;
          -  Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;&#xD;
&#xD;
          -  Admitted patients with expected hospital discharge in less than 24 hours;&#xD;
&#xD;
          -  Patient unable to sign the consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosa Pereira, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Medicine, University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Gualano, PhD</last_name>
    <role>Study Director</role>
    <affiliation>School of Medicine, University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Hospital of the School of Medicine, University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>ROSA MARIA RODRIGUES PEREIRA</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>vitamin D</keyword>
  <keyword>acute respiratory syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449718
org study id: 30959620.4.0000.0068
nct id: NCT04449718
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Length of hospitalization
time frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
description: total number of days that patient remained hospitalized
measure: Mortality
time frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
description: number of patients that died
measure: 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
description: total number of days that patient remained in ICU
measure: 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
description: total number of days that patient remained in mechanic ventilator
measure: 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
measure: Inflammatory markers
time frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
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
measure: C-reactive protein
time frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
description: serum concentration
measure: Vitamin D
time frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
description: serum concentration
measure: Creatinine
time frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
description: serum concentration
measure: Calcium
time frame: Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month)
description: serum concentration
measure: Physical activity
time frame: Baseline
description: Baecke questionnaire (higher scores mean a higher physical activity level)
arm group label: Experimental
arm group type: Experimental
description: Patients will receive 200,000 IU of vitamin D3 on admission + conventional care
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive an equivalent amount of a placebo solution on admission + conventional care
intervention type: Dietary Supplement
intervention name: Vitamin D
description: 200,000 IU on admission
arm group label: Experimental
intervention type: Dietary Supplement
intervention name: Placebo
description: 200,000 IU on admission
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rosa Pereira, PhD, MD
role: Principal Investigator
affiliation: School of Medicine, University of Sao Paulo
last name: Bruno Gualano, PhD
role: Study Director
affiliation: School of Medicine, University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: ROSA MARIA RODRIGUES PEREIRA
investigator title: Dr
mesh term: COVID-19
mesh term: Vitamin D
sharing ipd: No