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

• Sponsor: Coordinación de Investigación en Salud, Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT04502667
• Collaborator: Hospital Infantil de Mexico Federico Gomez (Other), Hospital General de México Dr. Eduardo Liceaga (Other)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 3.2

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open controlled clinical trialOpen 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: Jul 15, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Sep 15, 2021

Arms and Interventions

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 Names: vitamin D
No Intervention: Control No intervention

Outcome Measures

Primary Outcome Measures

1. INTERLEUKINS (IL-2,6,7,10) (pg/ml) [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) [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 [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) [the beginning and through study completion, an average of 21 days]

   determination of 25-hydroxy-Vitamin D in human serum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Centro Medico Nacional Siglo XXI	Mexico City	Distrito Federal	Mexico	06720

Sponsors and Collaborators

• Coordinación de Investigación en Salud, Mexico
• Hospital Infantil de Mexico Federico Gomez
• Hospital General de México Dr. Eduardo Liceaga

Investigators

• Principal Investigator: JESSIE ZURITA-CRUZ, Coordinación de Investigación en Salud, Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 6, 2020
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: COVID-19; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Apr 8, 2022