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

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ClinicalTrials.gov Identifier: NCT04502667
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Hospital General de México Dr. Eduardo Liceaga
Information provided by (Responsible Party):
Jessie Nallelly Zurita Cruz, Coordinación de Investigación en Salud, Mexico

Tracking Information
First Submitted Date  ICMJE August 4, 2020
First Posted Date  ICMJE August 6, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19
Official Title  ICMJE Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Vitamin D
  • Children, Only
Intervention  ICMJE Drug: Cholecalciferol
1000U or 2000U every 24 hours orally
Other Name: vitamin D
Study Arms  ICMJE
  • Experimental: cholecalciferol (Vitamin D)
    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
    Intervention: Drug: Cholecalciferol
  • No Intervention: Control
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Age over 1 month and under 17 years
  2. Confirmed diagnosis of COVID-19 infection with the results of real-time PCR
  3. That they agreed to participate in the study.
  4. That the patient tolerates the enteral route

Exclusion criteria

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carla Castuera Martinez 56276900 ext 21218 carla_martinez@imss.gob.mx
Contact: Jessie N ZURITA-Cruz +525554194513 zuritajn@hotmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04502667
Other Study ID Numbers  ICMJE R-2020-3603-020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jessie Nallelly Zurita Cruz, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE
  • Hospital Infantil de Mexico Federico Gomez
  • Hospital General de México Dr. Eduardo Liceaga
Investigators  ICMJE
Principal Investigator: JESSIE ZURITA-CRUZ Coordinación de Investigación en Salud, Mexico
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP