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

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19)

• Registration Number: NCT04403932
• Lead Sponsor: Hospital San Carlos, Madrid

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

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 Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
severe COVID-19	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

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain