Vitamin D on Prevention and Treatment of COVID-19

NCT ID: NCT04334005

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Patients Infected With COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual care

Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention group

25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Manuel Castillo Garzón

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel J Castillo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Universidad de Granada

Granada, Andalusia, Spain

Site Status

Medicine Faculty

Granada, , Spain

Site Status

Countries

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Spain

Central Contacts

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Manuel J Castillo, MD, PhD

Role: CONTACT

+34 649440850

Facility Contacts

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Manuel J. Castillo Garzón

Role: primary

Proffesor Amaro Gahete, PhD student

Role: primary

697287022 ext. +34

Other Identifiers

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COVITD-19

Identifier Type: -

Identifier Source: org_study_id

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