Vitamin D on Prevention and Treatment of COVID-19

Study Overview
=================
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.

Official Title
-----------------
Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19

Conditions
-----------------
Patients Infected With COVID-19

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. | Dietary Supplement: Vitamin D<br>* 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.<br>|
| Experimental: Intervention group<br>25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations. | Dietary Supplement: Vitamin D<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cumulative death (i.e. mortality) for all causes and for specific causes. |  | Through study completion, an average of 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necessity of invasive assisted ventilation |  | Through study completion, an average of 10 weeks | 
| Necessity of non-invasive assisted ventilation |  | Through study completion, an average of 10 weeks | 
| Intensive care unit admission |  | Through study completion, an average of 10 weeks | 
| Post-anesthesia care unit admission |  | Through study completion, an average of 10 weeks | 
| Hospital admission |  | Through study completion, an average of 10 weeks | 
| Medical consultation |  | Through study completion, an average of 10 weeks | 
| Home care and isolation time |  | Through study completion, an average of 10 weeks | 
| Bed rest time |  | 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) |  | Through study completion, an average of 10 weeks | 
| Subjective perception of recovery | It will be measure by questionnaire | Through study completion, an average of 10 weeks |