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History of Changes for Study: NCT04334005
Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)
Latest version (submitted April 3, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 2, 2020 None (earliest Version on record)
2 April 3, 2020 Recruitment Status, Study Status and Outcome Measures
Comparison Format:

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Study NCT04334005
Submitted Date:  April 2, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: COVITD-19
Brief Title: Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)
Official Title: Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: April 10, 2020
Primary Completion: June 30, 2020 [Anticipated]
Study Completion: June 30, 2020 [Anticipated]
First Submitted: March 29, 2020
First Submitted that
Met QC Criteria:
April 2, 2020
First Posted: April 3, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 2, 2020
Last Update Posted: April 3, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Universidad de Granada
Responsible Party: Principal Investigator
Investigator: Manuel Castillo Garzón
Official Title: MD, PhD
Affiliation: Universidad de Granada
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Patients Infected With COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Usual care
Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
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.
Experimental: Intervention group
25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
[ Time Frame: Through study completion, an average of 10 weeks ]

Secondary Outcome Measures:
1. Necessity of invasive assisted ventilation
[ Time Frame: Through study completion, an average of 10 weeks ]

2. Necessity of non-invasive assisted ventilation
[ Time Frame: Through study completion, an average of 10 weeks ]

3. Intensive care unit admission
[ Time Frame: Through study completion, an average of 10 weeks ]

4. Post-anesthesia care unit admission
[ Time Frame: Through study completion, an average of 10 weeks ]

5. Hospital admission
[ Time Frame: Through study completion, an average of 10 weeks ]

6. Medical consultation
[ Time Frame: Through study completion, an average of 10 weeks ]

7. Home care and isolation time
[ Time Frame: Through study completion, an average of 10 weeks ]

8. Bed rest time
[ Time Frame: Through study completion, an average of 10 weeks ]

9. 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 ]

10. Subjective perception of recovery
[ Time Frame: Through study completion, an average of 10 weeks ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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).
Open or close this module Contacts/Locations
Central Contact Person: Manuel J Castillo, MD, PhD
Telephone: +34 649440850
Email: mcgarzon@ugr.es
Study Officials: Manuel J Castillo, MD, PhD
Principal Investigator
Universidad de Granada
Locations: Spain
Medicine Faculty
Granada, Spain, 18001
Contact:Contact: Proffesor Amaro Gahete, PhD student 697287022 Ext. +34 amarof@ugr.es
Spain, Andalucia
Universidad de Granada
Granada, Andalucia, Spain, 18071
Contact:Contact: Manuel J. Castillo Garzón mcgarzon@ugr.es
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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