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Efficacy of Vitamin D Supplementation for Children With Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Vitamin D, Children

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 3 to 24 months. Clinical diagnosis of first episode of bronchiolitis First 24 hours of admission. Stable or decreasing requirement for oxygen on 2 measurements 2 hours apart. Pulse rate less than 180 beat/minute. Respiratory rate less than 80 breath/min. Oxygen supplementation < 40% Fraction of inspired oxygen or < 2 L/min by nasal prong Not on high flow nasal cannula, continuous positive airway pressure, or mechanical ventilation at the time of enrollment. Exclusion Criteria: .• History of previous episodes of wheezing. History of apnea Need for positive pressure support or high flow nasal cannula at the time of enrollment. Chronic lung disease (requiring home oxygen, or pulmonary hypertension) Cardiac disease (cyanotic, hemodynamically significant [requiring diuretics], or pulmonary hypertension). Neuromuscular disease. Metabolic disease. Immunodeficiency. Chromosomal abnormalities. Craniofacial malformation Hemoglobinopathy. Hypercalcemia Chromosomal abnormalities Use of large doses of vitamin D (> 400 IU/day) in the last month.

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

Children receive a single dose of intramuscular 200,000 IU vitamin D3

Children receiving only the standard recommended dose of vitamin D3 as 400 IU/day orally

Outcomes

Primary Outcome Measures

Time from randomization to discharge
Time from randomization to hospital discharge (in hours)

Secondary Outcome Measures

Time from randomization to discontinuation of oxygen therapy
Time from randomization to discontinuation of oxygen therapy (in hours)
Time from randomization to discontinuation of intravenous fluids
Time from randomization to discontinuation of intravenous fluids (in hours)
Time from randomization to meeting discharge criteria
Time from randomization to meeting hospital discharge criteria (in hours)
Time from hospital admission to discharge
Time from hospital admission to discharge (in hours)
Blood level of 25-hydroxycholecalciferol
Blood level of 25-hydroxycholecalciferol
Serum level of ionized calcium
Serum level of ionized calcium
Admission to pediatric intensive care unit
Proportion of patients admitted to pediatric intensive care unit
Intubation
Proportion of patients who underwent endotracheal intubation
Mortality
Proportion of patients who died during hospital admission
Bronchodilator therapy
Proportion of patients who received bronchodilator therapy
Systemic steroids
Proportion of patients who received systemic steroids

Full Information

First Posted
March 8, 2023
Last Updated
April 1, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05795933
Brief Title
Efficacy of Vitamin D Supplementation for Children With Bronchiolitis
Official Title
Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings. In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.
Detailed Description
Bronchiolitis is the most frequent lower respiratory tract infection in children under two years of age, which represents a major cause of medical visits, hospital admissions, and death. This disease predominantly affects small airways with acute inflammatory edema epithelial cells, excess mucus production, and bronchospasm. The most commonly involved organisms are Respiratory Syncytial Virus (accounting for 60% of cases), followed by Rhinovirus, Parainfluenza, Metapneumovirus, Influenza, and Adenovirus. Certain factors are associated with a higher risk of severe bronchiolitis, such as prematurity, chronic lung disease, cardiac disease, immunodeficiency, neuromuscular disease, and Down syndrome. Diagnosis of bronchiolitis relies on a constellation of clinical manifestations, including respiratory distress and wheezing preceded by viral upper respiratory tract prodrome in children under two years of age. Common manifestations of bronchiolitis are rhinorrhea, cough, wheezing, tachypnea, and increased work of breathing, including nasal flaring, retractions, and grunting. Management of bronchiolitis is mainly supportive, aiming at maintaining adequate oxygenation and hydration. Given the high burden of bronchiolitis and the lack of specific treatment, studies have investigated several therapeutic options. One of these potential therapies is vitamin D. Vitamin D is a fat-soluble vitamin that is mainly formed in the skin after exposure to ultraviolet rays, while less than 10% is obtained from dietary sources. Besides regulation of calcium and phosphorus homeostasis, vitamin D plays an important role in enhancing mucosal immune defense, decreasing excessive inflammation, and increasing mucociliary clearance. Vitamin D deficiency is common among children, particularly in developing countries, and has been linked to an increased risk of several diseases, including bronchiolitis, pneumonia, and otitis media. Experimental studies have shown that vitamin D reduces inflammation of epithelial cells in airways infected with Respiratory Syncytial Virus and confers antiviral effects. Furthermore, several studies have shown lower serum vitamin D levels in hospitalized children with bronchiolitis. However, studies on the efficacy of Vitamin D supplementation for children with bronchiolitis are scarce with inconsistent findings. In this study, we aim to evaluate the efficacy of vitamin D supplementation in children with bronchiolitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Vitamin D, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Two groups of children with bronchiolitis: Study group: will receive a single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission. Control group: will receive the standard recommended dose of vitamin D3 as 400 IU/day orally
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Children receive a single dose of intramuscular 200,000 IU vitamin D3
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children receiving only the standard recommended dose of vitamin D3 as 400 IU/day orally
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol, Devarol
Intervention Description
A single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission
Primary Outcome Measure Information:
Title
Time from randomization to discharge
Description
Time from randomization to hospital discharge (in hours)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Time from randomization to discontinuation of oxygen therapy
Description
Time from randomization to discontinuation of oxygen therapy (in hours)
Time Frame
4 weeks
Title
Time from randomization to discontinuation of intravenous fluids
Description
Time from randomization to discontinuation of intravenous fluids (in hours)
Time Frame
4 weeks
Title
Time from randomization to meeting discharge criteria
Description
Time from randomization to meeting hospital discharge criteria (in hours)
Time Frame
4 weeks
Title
Time from hospital admission to discharge
Description
Time from hospital admission to discharge (in hours)
Time Frame
4 weeks
Title
Blood level of 25-hydroxycholecalciferol
Description
Blood level of 25-hydroxycholecalciferol
Time Frame
On day 3 after randomization
Title
Serum level of ionized calcium
Description
Serum level of ionized calcium
Time Frame
On day 3 after randomization
Title
Admission to pediatric intensive care unit
Description
Proportion of patients admitted to pediatric intensive care unit
Time Frame
4 weeks
Title
Intubation
Description
Proportion of patients who underwent endotracheal intubation
Time Frame
4 weeks
Title
Mortality
Description
Proportion of patients who died during hospital admission
Time Frame
4 weeks
Title
Bronchodilator therapy
Description
Proportion of patients who received bronchodilator therapy
Time Frame
4 weeks
Title
Systemic steroids
Description
Proportion of patients who received systemic steroids
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 3 to 24 months. Clinical diagnosis of first episode of bronchiolitis First 24 hours of admission. Stable or decreasing requirement for oxygen on 2 measurements 2 hours apart. Pulse rate less than 180 beat/minute. Respiratory rate less than 80 breath/min. Oxygen supplementation < 40% Fraction of inspired oxygen or < 2 L/min by nasal prong Not on high flow nasal cannula, continuous positive airway pressure, or mechanical ventilation at the time of enrollment. Exclusion Criteria: .• History of previous episodes of wheezing. History of apnea Need for positive pressure support or high flow nasal cannula at the time of enrollment. Chronic lung disease (requiring home oxygen, or pulmonary hypertension) Cardiac disease (cyanotic, hemodynamically significant [requiring diuretics], or pulmonary hypertension). Neuromuscular disease. Metabolic disease. Immunodeficiency. Chromosomal abnormalities. Craniofacial malformation Hemoglobinopathy. Hypercalcemia Chromosomal abnormalities Use of large doses of vitamin D (> 400 IU/day) in the last month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yostena S Labeeb, MD
Phone
01019492210
Email
youstinasafwat@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Elsayed Abdelkreem, MD, PhD
Phone
+201114232126
Email
d.elsayedmohammed@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa A Mohammed, MD, PhD
Organizational Affiliation
Sohag University
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahim A Sadek, MD, PhD
Email
abdoneurology@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Unidentified patients' data will be available upon reasonable request after publication
IPD Sharing Time Frame
After publication of the study
IPD Sharing Access Criteria
Unidentified patients' data will be available upon reasonable request after publication
Citations:
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36765418
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Efficacy of Vitamin D Supplementation for Children With Bronchiolitis

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