Efficacy of Vitamin D Supplementation for Children With Bronchiolitis

NCT05795933 | Completed Phase 2

• 1 other identifier: Soh-Med-23-03-11MS
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Vitamin D; Children

Outcome Measures

Primary Outcomes (1)

• Time from randomization to discharge

  Time from randomization to hospital discharge (in hours)

  4 weeks

Secondary Outcomes (11)

• Time from randomization to discontinuation of oxygen therapy

  4 weeks

• Time from randomization to discontinuation of intravenous fluids

  4 weeks

• Time from randomization to meeting discharge criteria

  4 weeks

• Time from hospital admission to discharge

  4 weeks

• Blood level of 25-hydroxycholecalciferol

  On day 3 after randomization

Study Arms (2)

Study group

EXPERIMENTAL

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

Drug: Vitamin D3

Control group

NO INTERVENTION

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

Interventions

Vitamin D3 DRUG

A single dose of intramuscular 200,000 IU vitamin D3 within 24 hours of admission

Also known as: Cholecalciferol, Devarol

Study group

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 82524, Egypt

Location

Related Publications (10)

• 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.

  PMID: 36765418 BACKGROUND

• 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.

  PMID: 25349312 BACKGROUND

• 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.

  PMID: 26745253 BACKGROUND

• 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.

  PMID: 26521023 BACKGROUND

• 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.

  PMID: 33931018 BACKGROUND

• 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.

  PMID: 35692038 BACKGROUND

• 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.

  PMID: 1731571 BACKGROUND

• 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.

  PMID: 35420658 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mostafa A Mohammed, MD, PhD

  Sohag University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident

Model Details: 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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: April 1, 2023
• Primary Completion: June 22, 2024
• Study Completion: July 14, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of the study
• Access Criteria: Unidentified patients' data will be available upon reasonable request after publication

Locations

EG (1)