NCT04552951.

Study name	Effect of vitamin D on morbidity and mortality of the COVID‐19 (COVID‐VIT‐D)
Methods	Trial design: RCT Sample size: 80 Setting: inpatient Language: English (Spain) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria > 18 years 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
Interventions	Details of intervention Dose: Single dose of 100,000 IU Route of administration: NI Treatment details of control group (e.g dose, route of administration): no vitamin D (on top of the current medication used to treat COVID 19). Concomitant therapy: none
Outcomes	Primary study outcome Mortality [Time Frame: time to death or hospital discharge] Review outcomes All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge ‐ reported Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale (WHO 2020e), WHO Ordinal Scale for Clinical Improvement (WHO 2020f)) at day 28, day 60, and up to longest follow‐up); including: Improvement of clinical status: weaning or liberation from invasive mechanical ventilation in surviving patients i.e. WHO ≤ 6, if ≥7 at baseline; ventilator‐free days; ventilator‐free defined as WHO ≤ 6; duration to liberation from invasive mechanical ventilation; liberation from supplemental oxygen in surviving patients i.e. WHO ≤ 4, if ≥ 5 at baseline; duration to liberation from supplemental oxygen; Worsening of clinical status: need for invasive mechanical ventilation i.e. WHO 7‐9, if ≤ 6 at baseline; need for non‐invasive mechanical ventilation or high flow i.e. WHO = 6, if ≤ 5 at baseline; need for oxygen by mask or nasal prongs i.e. WHO = 5, if ≤4 at baseline NP Need for dialysis (at up to 28 days) ‐ NP Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at up to seven days; up to 30 days, and longest follow‐up available ‐ NP Admission to ICU ‐ reported Duration of hospitalisation ‐ reported Time to discharge from hospital ‐ probably reported Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days ‐ NP Vitamin D serum levels ‐ NP Serious adverse events, defined as number of participants with event ‐ NP Adverse events (any grade, grade 1‐2, grade 3‐4), defined as number of participants with event ‐ NP Additional study outcomes Admission to Intensive Care Unit (ICU) Time of hospitalisation Clinical changes (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others) Radiological changes (pneumonia and severity) Inflammation markers changes (C‐reactive protein) Inflammation markers changes (Interleukin‐6) Inflammation markers changes (Leucocytes) Inflammation markers changes (D‐dimer) General biochemical parameters changes (Creatinine) General biochemical parameters changes (Ferritin) General biochemical parameters changes (Bilirubin) General biochemical parameters changes (Albumin) General biochemical parameters changes (Haemoglobin) General biochemical parameters changes (HDL cholesterol) General biochemical parameters changes (Procalcitonin) General biochemical parameters changes (Protonin) General biochemical parameters changes (Calcium) General biochemical parameters changes (Phosphate) General biochemical parameters changes (pO2)
Starting date	04/04/2020
Contact information	Jorge B Cannata‐Andía, MD PhD Hospital Universitario Central de Asturias *34 985 106137 cannata@hca.es
Notes	Recruitment status: recruiting Prospective completion date: 30/12/2020 Date last update was posted: 17/09/2020 Sponsor/funding: Fundación para la Investigación Biosanitaria del Principado de Asturias