Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency (COVIT-D)
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| ClinicalTrials.gov Identifier: NCT04403932 |
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Recruitment Status :
Completed
First Posted : May 27, 2020
Last Update Posted : February 1, 2021
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Sponsor:
Hospital San Carlos, Madrid
Information provided by (Responsible Party):
Fernando Macaya, Hospital San Carlos, Madrid
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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 |
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| Coronavirus Disease 2019 (COVID-19) |
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 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
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
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
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
| Spain | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
Sponsors and Collaborators
Hospital San Carlos, Madrid
| 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 |
| 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:
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Coronavirus Disease 2019 (COVID-19) Vitamin D Deficiency Severe Acute Respiratory Syndrome Angiotensin Converting Enzyme 2 |
Additional relevant MeSH terms:
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Coronavirus Infections Vitamin D Deficiency Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Virus Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |