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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-09-15

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.

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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.

Conditions

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Covid19 Vitamin D Children, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cholecalciferol (Vitamin D)

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

1000U or 2000U every 24 hours orally

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cholecalciferol

1000U or 2000U every 24 hours orally

Intervention Type DRUG

Other Intervention Names

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vitamin D

Eligibility Criteria

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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