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Vitamin D on Prevention and Treatment of COVID-19 (COVITD-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: NCT04334005
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Castillo Garzón, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE March 29, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date April 7, 2020
Estimated Study Start Date  ICMJE April 10, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
Composite of cumulative death (i.e. mortality) for all causes and for specific causes. [ Time Frame: Through study completion, an average of 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • Necessity of invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Necessity of non-invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Intensive care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Post-anesthesia care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Hospital admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Medical consultation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Home care and isolation time [ Time Frame: Through study completion, an average of 10 weeks ]
  • Bed rest time [ Time Frame: Through study completion, an average of 10 weeks ]
  • symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19) [ Time Frame: Through study completion, an average of 10 weeks ]
  • Subjective perception of recovery [ Time Frame: Through study completion, an average of 10 weeks ]
    It will be measure by questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Necessity of invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Necessity of non-invasive assisted ventilation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Intensive care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Post-anesthesia care unit admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Hospital admission [ Time Frame: Through study completion, an average of 10 weeks ]
  • Medical consultation [ Time Frame: Through study completion, an average of 10 weeks ]
  • Home care and isolation time [ Time Frame: Through study completion, an average of 10 weeks ]
  • Bed rest time [ Time Frame: Through study completion, an average of 10 weeks ]
  • symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19) [ Time Frame: Through study completion, an average of 10 weeks ]
  • Subjective perception of recovery [ Time Frame: Through study completion, an average of 10 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D on Prevention and Treatment of COVID-19
Official Title  ICMJE Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
Brief Summary The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patients Infected With COVID-19
Intervention  ICMJE Dietary Supplement: Vitamin D
The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.
Study Arms  ICMJE
  • Active Comparator: Usual care
    Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
    Intervention: Dietary Supplement: Vitamin D
  • Experimental: Intervention group
    25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.
    Intervention: Dietary Supplement: Vitamin D
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.

Exclusion Criteria:

  • Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Manuel J Castillo, MD, PhD +34 649440850 mcgarzon@ugr.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334005
Other Study ID Numbers  ICMJE COVITD-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Manuel Castillo Garzón, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel J Castillo, MD, PhD Universidad de Granada
PRS Account Universidad de Granada
Verification Date April 2020

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