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NCT04403932 Clinical Trial

Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency

Coronavirus Disease 2019 (COVID-19) Clinical Trial

— COVIT-D  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04403932
Other study ID # 20/428-E_COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date August 1, 2020

Study information
Verified date January 2021
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date August 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital Clínico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary severe COVID-19 death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula 17/04/2020 to 01/06/2020
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