NCT04385940.

Study name	Vitamin D and COVID‐19 management
Methods	Trial design: RCT Sample size: 64 Setting: Mixed (inpatient and outpatient) Language: English (USA) Number of centres: NR Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Patients with COVID‐19 ≥ 17 years old Both sexes Exclusion criteria Patients with dementia, learning disability, mental health needs and alcohol or drug dependency, pregnant women Patients with sarcoidosis, hypercalcemia, known vitamin D intolerance
Interventions	Details of intervention Dose: Ddrops® product Vitamin D3 50,000 IU Route of administration: oral Treatment details of control group (e.g dose, route of administration): Vitamin D3 1000 IU Concomitant therapy: none
Outcomes	Primary study outcome Symptoms recovery Review outcomes Outpatient setting All‐cause mortality at day 28, day 60, time‐to‐event, and up to longest follow‐up ‐ NP Admission to hospital (WHO≥ 4) ‐ reported Development of moderate to severe clinical COVID‐19 symptoms, defined as WHO Clinical Progression Scale ≥ 6 (WHO 2020e), up to longest follow‐up Need for invasive mechanical ventilation, non‐invasive mechanical ventilation or high flow i.e. WHO ≥ 6, severe disease; need for invasive mechanical ventilation i.e. WHO 7‐9; need for non‐invasive mechanical ventilation or high flow i.e. WHO = 6. Need for hospitalisation with or without supplemental oxygen i.e. WHO = 4‐5, moderate disease; need for oxygen by mask or nasal prongs i.e. WHO = 5; need for hospitalisation without oxygen therapy i.e. WHO = 4. NP Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at up to 7 days, up to 30 days, and longest follow‐up available ‐ NP Duration of hospitalisation, for subgroup of participants hospitalised during course of disease ‐ reported Time to hospital discharge, for subgroup of participants hospitalised during course of disease ‐ probably reported 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 Inpatient setting All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge ‐ NP 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 ‐ probably 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 ‐ 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 Hospitalisation Blood white blood cell count (WBC) Duration of mechanical ventilation Duration of hospitalisation Intensive care unit (ICU) admission Duration of ICU stay Blood C‐reactive protein (CRP) Blood Lymphocyte count Blood Ferritin Blood platelet count Blood interleukin‐6 (IL‐6) Blood Tumor Necrosis Factor alpha (TNF)
Starting date	06/2020
Contact information	Aldo Montano‐Loza Associate Professor of Medicine, Program Director of Hepatology University of Alberta
Notes	Recruitment status: not yet recruiting Prospective completion date: 12/2020 Date last update was posted: 05/06/2020 Sponsor/funding: University of Alberta