Skip to main content
OpenTrials
Completed

NCT Number: NCT04502667

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Centro Medico Nacional Siglo XXI

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Cholecalciferol

Drug

1000U or 2000U every 24 hours orally

Other names: vitamin D

Primary outcomes

  1. INTERLEUKINS (IL-2,6,7,10) (pg/ml)

    Time frame: 7 days

    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.

  2. FERRITIN (ng/ml)

    Time frame: 7 days

    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.

  3. DIMER-D

    Time frame: 7 days

    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 outcomes

  1. Vitamin D (ng/ml)

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

    determination of 25-hydroxy-Vitamin D in human serum

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Hospital General de México Dr. Eduardo Liceaga
  • Hospital Infantil de Mexico Federico Gomez

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.