Effect of Vitamin D on Morbidity and Mortality of the COVID-19 (COVID-VIT-D)

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

Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias

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.

Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )

Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)

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

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.