NCT04502667.

Study name	Efficacy of vitamin D treatment in pediatric Patients hospitalized by COVID‐19: open controlled clinical trial
Methods	Trial design: RCT Sample size: 40 Setting: inpatient Language: English (Mexico) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age over 1 month and under 17 years (children) Confirmed diagnosis of COVID‐19 infection with the results of real‐time PCR That they agreed to participate in the study That the patient tolerates the enteral route Exclusion criteria Have received vitamin D in the four weeks prior to hospitalisation
Interventions	Details of intervention Dose: Children under 12 months they will be given 1000 U of Vitamin D and in children over 12 months they will be given 2000 U of Vitamin D Route of administration: every 24 hours orally during hospitalisation Treatment details of control group (e.g dose, route of administration): no intervention Concomitant therapy: none
Outcomes	Primary study outcome Interleukins Ferritin Dimder‐D Review outcomes 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 ‐ NP Duration of hospitalisation ‐ NP 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 ‐ reported 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: Vitamin D serum levels
Starting date	15/07/2020
Contact information	Hospital Centro Medico Nacional Siglo XXI Carla Castuera Martinez 56276900 ext 21218 carla_martinez@imss.gob.mx
Notes	Recruitment status: recruiting Prospective completion date: 04/2021 Date last update was posted: 06/08/2020 Sponsor/funding: Coordinación de Investigación en Salud, Mexico