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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04403932
Acronym
COVIT-D
Enrollment
300
Registered
2020-05-27
Start date
2020-04-17
Completion date
2020-08-01
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

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

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.

Interventions

None listed

Sponsors

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
severe COVID-1917/04/2020 to 01/06/2020death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026