Vitamin D on Prevention and Treatment of COVID-19

Not Applicable

• Conditions: Patients Infected With COVID-19
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT04334005
• Lead Sponsor: Universidad de Granada

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 available

Study Timeline

• Study First Submitted: 2020-03-29
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07
• Study Start: 2020-04-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Vitamin D	Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
Intervention group	Vitamin D	25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Through study completion, an average of 10 weeks	It will be measure by questionnaire

Trial Locations

Locations (2)

Medicine Faculty; 🇪🇸 Granada, Spain

Universidad de Granada; 🇪🇸 Granada, Andalucia, Spain