Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital

Soh-Med-23-03-11MS

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.

2023-04-01

2024-04-01

2024-05-01

Recruiting

Early phase I

146

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of children with bronchiolitis:\n\nStudy group: will receive a single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission.\n\nControl group: will receive the standard recommended dose of vitamin D3 as 400 IU/day orally', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 146, 'type': 'ESTIMATED'}}

2023-04-04