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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

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.

Condition or disease Intervention/treatment Phase
Covid19 Vitamin D Children, Only Drug: Cholecalciferol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open controlled clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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
Drug: Cholecalciferol
1000U or 2000U every 24 hours orally
Other Name: vitamin D

No Intervention: Control
No intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502667


Contacts
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Contact: Carla Castuera Martinez 56276900 ext 21218 carla_martinez@imss.gob.mx
Contact: Jessie N ZURITA-Cruz +525554194513 zuritajn@hotmail.com

Locations
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Mexico
Hospital Centro Medico Nacional Siglo XXI Recruiting
Mexico City, Distrito Federal, Mexico, 06720
Contact: Jessie ZURITA-CRUZ    56276900    zuritajn@hotmail.com   
Contact: Miguel Angel Villasis-Keever    56276900    miguel.villasis@gmail.com   
Principal Investigator: Guadalupe Miranda-Novales, PhD         
Principal Investigator: JESSIE ZURITA-CRUZ, PhD         
Sub-Investigator: Miguel Villasis-Keever, PhD         
Sub-Investigator: Mardia Lopez-Alarcon, PhD         
Sub-Investigator: Carmen Espinosa-Sotelo, MD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Hospital Infantil de Mexico Federico Gomez
Hospital General de México Dr. Eduardo Liceaga
Investigators
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Principal Investigator: JESSIE ZURITA-CRUZ Coordinación de Investigación en Salud, Mexico
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Responsible Party: Jessie Nallelly Zurita Cruz, principal investigator, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04502667    
Other Study ID Numbers: R-2020-3603-020
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents