Efficacy of Vitamin D Supplementation for Children With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795933
• Other study ID #: Soh-Med-23-03-11MS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: Yostena S Labeeb, MD
• Phone: 01019492210
• Email: youstinasafwat[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Vitamin D3
A single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410. — View Citation

Esposito S, Lelii M. Vitamin D and respiratory tract infections in childhood. BMC Infect Dis. 2015 Oct 28;15:487. doi: 10.1186/s12879-015-1196-1. — View Citation

Golan-Tripto I, Loewenthal N, Tal A, Dizitzer Y, Baumfeld Y, Goldbart A. Vitamin D deficiency in children with acute bronchiolitis: a prospective cross-sectional case- control study. BMC Pediatr. 2021 Apr 30;21(1):211. doi: 10.1186/s12887-021-02666-4. — View Citation

Khoshnevisasl P, Sadeghzadeh M, Kamali K, Ardalani A. A randomized clinical trial to assess the effect of zinc and vitamin D supplementation in addition to hypertonic saline on treatment of acute bronchiolitis. BMC Infect Dis. 2022 Jun 13;22(1):538. doi: 10.1186/s12879-022-07492-2. — View Citation

Manti S, Staiano A, Orfeo L, Midulla F, Marseglia GL, Ghizzi C, Zampogna S, Carnielli VP, Favilli S, Ruggieri M, Perri D, Di Mauro G, Gattinara GC, D'Avino A, Becherucci P, Prete A, Zampino G, Lanari M, Biban P, Manzoni P, Esposito S, Corsello G, Baraldi E. UPDATE - 2022 Italian guidelines on the management of bronchiolitis in infants. Ital J Pediatr. 2023 Feb 10;49(1):19. doi: 10.1186/s13052-022-01392-6. — View Citation

Munns CF, Shaw N, Kiely M, Specker BL, Thacher TD, Ozono K, Michigami T, Tiosano D, Mughal MZ, Makitie O, Ramos-Abad L, Ward L, DiMeglio LA, Atapattu N, Cassinelli H, Braegger C, Pettifor JM, Seth A, Idris HW, Bhatia V, Fu J, Goldberg G, Savendahl L, Khadgawat R, Pludowski P, Maddock J, Hypponen E, Oduwole A, Frew E, Aguiar M, Tulchinsky T, Butler G, Hogler W. Global Consensus Recommendations on Prevention and Management of Nutritional Rickets. J Clin Endocrinol Metab. 2016 Feb;101(2):394-415. doi: 10.1210/jc.2015-2175. Epub 2016 Jan 8. — View Citation

Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum In: Pediatrics. 2015 Oct;136(4):782. — View Citation

Saad K, Abd Aziz NH, El-Houfey AA, El-Asheer O, Mohamed SA, Ahmed AE, Abdel Baseer KA, Darwish MM. Trial of vitamin D supplementation in infants with bronchiolitis: a randomized, double-blind, placebo-controlled study. Pediatric Allergy, Immunology, and Pulmonology. 2015;28(2):102-6

Sarhan AA, Saeed NM, Mostafa AA, Osman AM. Vitamin D supplementation for acute bronchiolitis: a double-blind randomized controlled trial. Alexandria Journal of Pediatrics. 2019;32(2):61.

Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992 Jan;145(1):106-9. doi: 10.1164/ajrccm/145.1.106. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to discharge	Time from randomization to hospital discharge (in hours)	4 weeks
Secondary	Time from randomization to discontinuation of oxygen therapy	Time from randomization to discontinuation of oxygen therapy (in hours)	4 weeks
Secondary	Time from randomization to discontinuation of intravenous fluids	Time from randomization to discontinuation of intravenous fluids (in hours)	4 weeks
Secondary	Time from randomization to meeting discharge criteria	Time from randomization to meeting hospital discharge criteria (in hours)	4 weeks
Secondary	Time from hospital admission to discharge	Time from hospital admission to discharge (in hours)	4 weeks
Secondary	Blood level of 25-hydroxycholecalciferol	Blood level of 25-hydroxycholecalciferol	On day 3 after randomization
Secondary	Serum level of ionized calcium	Serum level of ionized calcium	On day 3 after randomization
Secondary	Admission to pediatric intensive care unit	Proportion of patients admitted to pediatric intensive care unit	4 weeks
Secondary	Intubation	Proportion of patients who underwent endotracheal intubation	4 weeks
Secondary	Mortality	Proportion of patients who died during hospital admission	4 weeks
Secondary	Bronchodilator therapy	Proportion of patients who received bronchodilator therapy	4 weeks
Secondary	Systemic steroids	Proportion of patients who received systemic steroids	4 weeks