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

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.

Condition or disease	Intervention/treatment	Phase
Patients Infected With COVID-19	Dietary Supplement: Vitamin D	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
• Estimated Study Start Date: April 10, 2020
• Estimated Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: June 30, 2020

Arms and Interventions

Arm	Intervention/treatment
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.

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 ]
    It will be measure by questionnaire

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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).

Contacts and Locations

Contacts

Contact: Manuel J Castillo, MD, PhD; +34 649440850; mcgarzon@ugr.es

Locations

Spain

Universidad de Granada

Granada, Andalucia, Spain, 18071

Contact: Manuel J. Castillo Garzón mcgarzon@ugr.es

Medicine Faculty

Granada, Spain, 18001

Contact: Proffesor Amaro Gahete, PhD student 697287022 ext +34 amarof@ugr.es

Sponsors and Collaborators

Universidad de Granada

Investigators

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

More Information

• Responsible Party: Manuel Castillo Garzón, MD, PhD, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT04334005
• Other Study ID Numbers: COVITD-19
• First Posted: April 3, 2020
• Last Update Posted: April 7, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents