NCT04502667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Jul 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

August 4, 2020

Last Update Submit

April 7, 2022

Conditions

Covid19Vitamin DChildren, Only

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Vitamin D (ng/ml)

    the beginning and through study completion, an average of 21 days

Study Arms (2)

cholecalciferol (Vitamin D)

EXPERIMENTAL

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

Drug: Cholecalciferol

Control

NO INTERVENTION

No intervention

Interventions

CholecalciferolDRUG

1000U or 2000U every 24 hours orally

Also known as: vitamin D
cholecalciferol (Vitamin D)

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \. Have received vitamin D in the four weeks prior to hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Centro Medico Nacional Siglo XXI

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 35958172DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • JESSIE ZURITA-CRUZ

    Coordinación de Investigación en Salud, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open controlled clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 6, 2020

Study Start

July 15, 2020

Primary Completion

March 31, 2021

Study Completion

September 15, 2021

Last Updated

April 8, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)