NCT04621058.

Study name	Efficacy of vitamin D treatment in mortality reduction due to COVID‐19
Methods	Trial design: RCT Sample size: 108 Setting: inpatient Language: English (Spain) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/mL Possibility for observation during the treatment period Signing of written consent (oral informed consent exceptionally) Positive PCR for diagnosis of SARS‐COV2 infection Exclusion criteria Patients taking any type of vitamin D supplement Patients with hypoparathyroidism Pregnant or lactating women Patients in whom the administration of vitamin D is formally contraindicated Patients who at time of inclusion, cannot take vitamin D orally
Interventions	Details of intervention: in case of Vitamin D levels < 30 ng/mLor 40 ng/mL (deficiency) patients will take vitamin D supplements (soft capsules) Dose: 1 or 2 capsules 0.266 mg depending on deficiency Route of administration: oral Treatment details of control group (e.g dose, route of administration): placebo capsules Concomitant therapy: none
Outcomes	Primary study outcome Mortality (21 days) Review outcomes All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge ‐ probably 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 7 days; up to 30 days, and longest follow‐up available ‐ NP Admission to ICU ‐ reported Duration of hospitalisation ‐ reported Time to discharge from hospital ‐ NP 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 review outcomes ICU admissions Length of hospital stay Prevalence of vitamin D deficiency (at baseline) Incremental cost effectiveness ratio (ICER)
Starting date	09/11/2020
Contact information	Joaquín Durán Cantolla Vitoria‐Gasteiz, Alava, Spain, 01002 +34945207925 joaquin.durancantolla@gmail.com
Notes	Recruitment status: recruiting Prospective completion date: 30/11/2021 Date last update was posted: 23/12/2020 Sponsor/funding: Bioaraba Health Research Institute