Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 1:26 AM
Study NCT ID:
NCT04403932
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency
Sponsor:
Hospital San Carlos, Madrid
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIT-D
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: