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

Covid19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502667
• Other study ID #: R-2020-3603-020
• Status: Completed
• Phase: Phase 3
• Start date: July 15, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: April 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 15, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children, Only
• COVID-19
• Covid19
• Vitamin D

Intervention

Drug:
• Cholecalciferol
1000U or 2000U every 24 hours orally

Locations

Country	Name	City	State
Mexico	Hospital Centro Medico Nacional Siglo XXI	Mexico City	Distrito Federal

Sponsors (3)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Hospital General de México Dr. Eduardo Liceaga, Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Vitamin D (ng/ml)	determination of 25-hydroxy-Vitamin D in human serum	the beginning and through study completion, an average of 21 days