Children, Only, Covid19, Vitamin D
Conditions
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.
Interventions
DRUGCholecalciferol
1000U or 2000U every 24 hours orally
Sponsors
Hospital Infantil de Mexico Federico Gomez
Hospital General de México Dr. Eduardo Liceaga
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INTERLEUKINS (IL-2,6,7,10) (pg/ml) | 7 days | 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. |
| FERRITIN (ng/ml) | 7 days | 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. |
| DIMER-D | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D (ng/ml) | the beginning and through study completion, an average of 21 days | determination of 25-hydroxy-Vitamin D in human serum |
Countries
Mexico
Outcome results
None listed