Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency (COVIT-D)

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ClinicalTrials.gov Identifier: NCT04403932

Recruitment Status : Completed

First Posted : May 27, 2020

Last Update Posted : February 1, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Fernando Macaya, Hospital San Carlos, Madrid

Study Description

Brief Summary:

In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Condition or disease
Coronavirus Disease 2019 (COVID-19)

Detailed Description:

Coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. The COVIT-D study (Increased risk of severe COVID-19 infection in patients with Vitamin D deficiency) is a prospective cohort study recruiting patients with confirmed COVID-19 seen at the emergency department of a tertiary hospital. A measurement of 25-hydroxyvitamin D is obtained at admission and follow-up obtained. The primary outcome is a composite of death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula. The primary association between VDD - categorised in groups - and the primary outcome will be evaluated with univariate analyses and multivariable logistic regression including the following prespecified confounders: age, gender, obesity and chronic kidney disease. The estimated sample size is n=500 and the expected inclusion time lapse 3 months.

Study Design

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Study Type :	Observational
Actual Enrollment :	300 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19)
Actual Study Start Date :	April 17, 2020
Actual Primary Completion Date :	June 1, 2020
Actual Study Completion Date :	August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Vitamin D Vitamin D Deficiency

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome Acute Graft Versus Host Disease

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

severe COVID-19 [ Time Frame: 17/04/2020 to 01/06/2020 ]
death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Consecutive adult subjects attending the emergency department with symptoms suggestive of COVID-19 and a positive reverse-transcriptase polymerase chain reaction for SARS-CoV-2

Criteria

Inclusion Criteria:

>18 years old
symptoms suggestive of COVID-19
positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2

Exclusion Criteria:

Bacterial community acquired pneumonia

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403932

Locations

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Spain
Hospital Clínico San Carlos
Madrid, Spain, 28040

Sponsors and Collaborators

Hospital San Carlos, Madrid

More Information

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Responsible Party:	Fernando Macaya, MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT04403932
Other Study ID Numbers:	20/428-E_COVID
First Posted:	May 27, 2020 Key Record Dates
Last Update Posted:	February 1, 2021
Last Verified:	January 2021

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

Keywords provided by Fernando Macaya, Hospital San Carlos, Madrid:


Coronavirus Disease 2019 (COVID-19) Vitamin D Deficiency Severe Acute Respiratory Syndrome Angiotensin Converting Enzyme 2

Additional relevant MeSH terms:

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COVID-19 Coronavirus Infections Vitamin D Deficiency Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders

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