Sohag University Hospital
Sohag, 82524, Egypt
NCT Number: NCT05795933
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.
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Notify Me3 month–24 month
All sexes
Interventional
Phase 2 / Phase 3
Sohag, 82524, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
.• History of previous episodes of wheezing.
A single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission
Other names: Cholecalciferol, Devarol
Time frame: 4 weeks
Time from randomization to hospital discharge (in hours)
Time frame: 4 weeks
Time from randomization to discontinuation of oxygen therapy (in hours)
Time frame: 4 weeks
Time from randomization to discontinuation of intravenous fluids (in hours)
Time frame: 4 weeks
Time from randomization to meeting hospital discharge criteria (in hours)
Time frame: 4 weeks
Time from hospital admission to discharge (in hours)
Time frame: On day 3 after randomization
Blood level of 25-hydroxycholecalciferol
Time frame: On day 3 after randomization
Serum level of ionized calcium
Time frame: 4 weeks
Proportion of patients admitted to pediatric intensive care unit
Time frame: 4 weeks
Proportion of patients who underwent endotracheal intubation
Time frame: 4 weeks
Proportion of patients who died during hospital admission
Time frame: 4 weeks
Proportion of patients who received bronchodilator therapy
Time frame: 4 weeks
Proportion of patients who received systemic steroids
Sohag University
Other
Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital
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