Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)

• ClinicalTrials.gov Identifier: NCT04334005
• Recruitment Status: Unknown
• First Posted: April 3, 2020
• Last Update Posted: April 7, 2020
• Sponsor: Universidad de Granada
• Information provided by (Responsible Party): Manuel Castillo Garzón, Universidad de Granada

Tracking Information

• First Submitted Date: March 29, 2020
• First Posted Date: April 3, 2020
• Last Update Posted Date: April 7, 2020
• Estimated Study Start Date: April 10, 2020
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Vitamin D on Prevention and Treatment of COVID-19
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Patients Infected With COVID-19

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 2, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2020
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04334005
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Manuel Castillo Garzón, Universidad de Granada
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad de Granada
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Manuel J Castillo, MD, PhD; Universidad de Granada

• PRS Account: Universidad de Granada
• Verification Date: April 2020