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
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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