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| Name | Class |
|---|---|
| Hospital Universitario Central de Asturias | OTHER |
| Instituto de Investigación Sanitaria del Principado de Asturias | UNKNOWN |
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Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).
Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.
Efficacy parameters to compare both groups (vitamin D and No vitamin D).
Time to reach undetectable levels of SARS COV2 Infection.
Time of normalization of symptoms and clinical parameters.
Time of normalization of radiological images.
Time of normalization of biochemical markers.
Time of normalization of molecular inflammatory markers.
Transfer to the Intensive care Unit.
Mortality rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed |
|
| Control | No Intervention | No vitamin D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Single doe of 100.000 IU |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Percentage of patients dying during hospitalization | Time to death or hospital discharge in days (average 12 days) |
| Admission to Intensive Care Unit (ICU) | Percentage of patients admitted to ICU and time in ICU | Time from hospital admission to discharge in days (average 12 days) |
| Time of hospitalization | Number of days from hospital admission to discharge | Time of hospitalization in days (average 12 days) |
| Clinical changes | Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...) | At the time of hospital admission and discharge (average 12 days) |
| Radiological changes | Changes in the percentage of patients with radiological findings of pneumonia and severity | At the time of hospital admission and discharge (average 12 days) |
| Calcidiol changes | Calcidiol levels in ng/mL. | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| Inflammation markers changes (CRP) | C-reactive protein (CRP) in mg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge B Cannata-Andía, MD PhD | Contact | *34 985 106137 | cannata@hca.es | |
| Juan Pérez-Ortega | Contact | *34 985109905 | juan.perez@finba.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35177066 | Derived | Cannata-Andia JB, Diaz-Sottolano A, Fernandez P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-Lopez N, Panizo S, Ibanez GH, Cusumano CA, Ballarino C, Sanchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calvino-Varela J, Gomez MD, Gomez-Alonso C, Cunningham J, Naves-Diaz M, Douthat W, Fernandez-Martin JL; COVID-VIT-D trial collaborators. A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial. BMC Med. 2022 Feb 18;20(1):83. doi: 10.1186/s12916-022-02290-8. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
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| Inflammation markers changes (IL-6) | Interleukin-6 (IL-6) in pg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| Inflammation markers changes (Leucocytes) | Leucocytes in cells per liter | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| Inflammation markers changes (D-dimer) | D-dimer in µg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Creatinine) | Creatinine in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Ferritin) | Ferritin in µg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Bilirubin) | Bilirubin in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Albumin) | Albumin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Haemoglobin) | Haemoglobin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (HDL cholesterol) | High density lipoprotein (HDL cholesterol) in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Procalcitonin) | Procalcitonin in ng/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Protonin) | Protonin in ng/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Calcium) | Calcium in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (Phosphate) | Phosphate in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| General biochemical parameters changes (pO2) | pO2 in mmHg | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |