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

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

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.

Study Overview

• Status: Unknown
• Conditions: Patients Infected With COVID-19
• Intervention / Treatment: Dietary supplement: Vitamin D

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel J Castillo, MD, PhD; Phone Number: +34 649440850; Email: mcgarzon@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18001
    • Medicine Faculty
    • Contact: Proffesor Amaro Gahete, PhD student; Phone Number: +34 697287022; Email: amarof@ugr.es
  • Andalucia
    • Granada, Andalucia, Spain, 18071
      • Universidad de Granada
      • Contact: Manuel J. Castillo Garzón; Email: mcgarzon@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: COVITD-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No