Clinical trial NCT04502667: Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19
Official title: Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Vitamin D
Children, Only
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
name: Hospital General de México Dr. Eduardo Liceaga
First posted: 2020-08-06
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin and Dimer D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning of hospitalization and on the 7th day after admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization.

Detailed description: Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19 performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D, interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs to. In case of being in the vitamin D group, in children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken on day 7 of admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization. On the day of hospital discharge, a blood sample will be taken to determine vitamin D.

Eligibility criteria: Inclusion criteria

1. Age over 1 month and under 17 years
2. Confirmed diagnosis of COVID-19 infection with the results of real-time PCR
3. That they agreed to participate in the study.
4. That the patient tolerates the enteral route

Exclusion criteria

1. Have received vitamin D in the four weeks prior to hospitalization.

Primary outcomes:
measure: INTERLEUKINS (IL-2,6,7,10) (pg/ml)
timeFrame: 7 days
measure: FERRITIN (ng/ml)
timeFrame: 7 days
measure: DIMER-D
timeFrame: 7 days
Secondary outcomes:
measure: Vitamin D (ng/ml)
timeFrame: the beginning and through study completion, an average of 21 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Centro Medico Nacional Siglo XXI
state: Distrito Federal
Study officials:
affiliation: Coordinación de Investigación en Salud, Mexico
name: JESSIE ZURITA-CRUZ
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zurita-Cruz J, Fonseca-Tenorio J, Villasis-Keever M, Lopez-Alarcon M, Parra-Ortega I, Lopez-Martinez B, Miranda-Novales G. Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial. Front Pediatr. 2022 Jul 25;10:943529. doi: 10.3389/fped.2022.943529. eCollection 2022.