Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial

Conditions
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Covid19, Vitamin D, Children, Only

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age over 1 month and under 17 years 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 1. Have received vitamin D in the four weeks prior to hospitalization.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecalciferol (Vitamin D)<br>Children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally during hospitalization | Drug: Cholecalciferol<br>* 1000U or 2000U every 24 hours orally<br>* Other names: vitamin D;|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INTERLEUKINS (IL-2,6,7,10) (pg/ml) | Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization. | 7 days | 
| FERRITIN (ng/ml) | Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization. | 7 days | 
| DIMER-D | Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D (ng/ml) | determination of 25-hydroxy-Vitamin D in human serum | the beginning and through study completion, an average of 21 days |