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Completed

NCT Number: NCT05795933

Efficacy of Vitamin D Supplementation for Children With Bronchiolitis

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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Key information

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sohag University Hospital

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Drug

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

Other names: Cholecalciferol, Devarol

Primary outcomes

  1. Time from randomization to discharge

    Time frame: 4 weeks

    Time from randomization to hospital discharge (in hours)

Secondary outcomes

  1. Time from randomization to discontinuation of oxygen therapy

    Time frame: 4 weeks

    Time from randomization to discontinuation of oxygen therapy (in hours)

  2. Time from randomization to discontinuation of intravenous fluids

    Time frame: 4 weeks

    Time from randomization to discontinuation of intravenous fluids (in hours)

  3. Time from randomization to meeting discharge criteria

    Time frame: 4 weeks

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

  4. Time from hospital admission to discharge

    Time frame: 4 weeks

    Time from hospital admission to discharge (in hours)

  5. Blood level of 25-hydroxycholecalciferol

    Time frame: On day 3 after randomization

    Blood level of 25-hydroxycholecalciferol

  6. Serum level of ionized calcium

    Time frame: On day 3 after randomization

    Serum level of ionized calcium

  7. Admission to pediatric intensive care unit

    Time frame: 4 weeks

    Proportion of patients admitted to pediatric intensive care unit

  8. Intubation

    Time frame: 4 weeks

    Proportion of patients who underwent endotracheal intubation

  9. Mortality

    Time frame: 4 weeks

    Proportion of patients who died during hospital admission

  10. Bronchodilator therapy

    Time frame: 4 weeks

    Proportion of patients who received bronchodilator therapy

  11. Systemic steroids

    Time frame: 4 weeks

    Proportion of patients who received systemic steroids

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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