Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19 (COVID-19)
Primary Purpose
Covid19, Vitamin D, Children, Only
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion criteria
- Age over 1 month and under 17 years
- Confirmed diagnosis of COVID-19 infection with the results of real-time PCR
- That they agreed to participate in the study.
- That the patient tolerates the enteral route
Exclusion criteria
1. Have received vitamin D in the four weeks prior to hospitalization.
Sites / Locations
- Hospital Centro Medico Nacional Siglo XXI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cholecalciferol (Vitamin D)
Control
Arm Description
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
No intervention
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Vitamin D (ng/ml)
determination of 25-hydroxy-Vitamin D in human serum
Full Information
NCT ID
NCT04502667
First Posted
August 4, 2020
Last Updated
April 7, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Hospital General de México Dr. Eduardo Liceaga
1. Study Identification
Unique Protocol Identification Number
NCT04502667
Brief Title
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19
Acronym
COVID-19
Official Title
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Hospital Infantil de Mexico Federico Gomez, Hospital General de México Dr. Eduardo Liceaga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Vitamin D, Children, Only
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cholecalciferol (Vitamin D)
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
vitamin D
Intervention Description
1000U or 2000U every 24 hours orally
Primary Outcome Measure Information:
Title
INTERLEUKINS (IL-2,6,7,10) (pg/ml)
Description
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.
Time Frame
7 days
Title
FERRITIN (ng/ml)
Description
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.
Time Frame
7 days
Title
DIMER-D
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Vitamin D (ng/ml)
Description
determination of 25-hydroxy-Vitamin D in human serum
Time Frame
the beginning and through study completion, an average of 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Age over 1 month and under 17 years
Confirmed diagnosis of COVID-19 infection with the results of real-time PCR
That they agreed to participate in the study.
That the patient tolerates the enteral route
Exclusion criteria
1. Have received vitamin D in the four weeks prior to hospitalization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JESSIE ZURITA-CRUZ
Organizational Affiliation
Coordinación de Investigación en Salud, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Centro Medico Nacional Siglo XXI
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35958172
Citation
Zurita-Cruz J, Fonseca-Tenorio J, Villasis-Keever M, Lopez-Alarcon M, Parra-Ortega I, Lopez-Martinez B, Miranda-Novales G. Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial. Front Pediatr. 2022 Jul 25;10:943529. doi: 10.3389/fped.2022.943529. eCollection 2022.
Results Reference
derived
Learn more about this trial
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19
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