Clinical trial NCT04552951: Effect of Vitamin D on Morbidity and Mortality of the COVID-19
Official title: Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Central de Asturias
name: Instituto de Investigación Sanitaria del Principado de Asturias
First posted: 2020-09-17
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* \> 18 year
* Diagnosis of COVID-19
* Accept to participate in the study ( consent)

Exclusion Criteria:

* Pregnancy
* Allergy to vitamin D
* Consumption of any form of vitamin D during the last 3 months
* Expected fatal outcome in the next 24 hours
* Cognitive deterioration

Primary outcomes:
measure: Mortality
timeFrame: Time to death or hospital discharge in days (average 12 days)
measure: Admission to Intensive Care Unit (ICU)
timeFrame: Time from hospital admission to discharge in days (average 12 days)
measure: Time of hospitalization
timeFrame: Time of hospitalization in days (average 12 days)
measure: Clinical changes
timeFrame: At the time of hospital admission and discharge (average 12 days)
measure: Radiological changes
timeFrame: At the time of hospital admission and discharge (average 12 days)
measure: Calcidiol changes
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: Inflammation markers changes (CRP)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: Inflammation markers changes (IL-6)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: Inflammation markers changes (Leucocytes)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: Inflammation markers changes (D-dimer)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Creatinine)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Ferritin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Bilirubin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Albumin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Haemoglobin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (HDL cholesterol)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Procalcitonin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Protonin)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Calcium)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (Phosphate)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
measure: General biochemical parameters changes (pO2)
timeFrame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
References:
citation: 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.