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

NCT04502667 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

  • Covid19
  • Vitamin D
  • Children, Only

Interventions

DRUG

Cholecalciferol

1000U or 2000U every 24 hours orally

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    collaborator OTHER
  • Hospital General de México Dr. Eduardo Liceaga

    collaborator OTHER_GOV
  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • JESSIE ZURITA-CRUZ · Coordinación de Investigación en Salud, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-03-31
Completion
2021-09-15

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502667 on ClinicalTrials.gov