Vitamin D Supplementation for Acute Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to evaluate the effect of oral vitamin D supplementation on the
      clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among
      infants who required hospital-based care for bronchiolitis is associated with the severity of
      the acute episode.
    

Detailed description: 
      This is a double blind randomized controlled trial which was conducted on 60 infants who
      required hospital-based care for acute bronchiolitis. The patients were recruited in the
      period from October 2018 to January 2019. Informed consents were obtained from all
      caregivers, and approved by Institutional Research Board of our University.

      The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress
      with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea,
      coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for
      bronchiolitis, since it is repeatable and can reliably be used in research and clinical
      practice

      Sample size:

      Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis
      was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80%
      to detect a clinical significance (α error) of 0.05 between interventional groups, we
      calculated a sample size of 30 patients in each treatment group.

      Randomization and Enrollment:

      Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute
      bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of
      admission as a previous cohort observational study has postulated that vitamin D daily dose
      close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were
      equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape
      and nearly the same taste and color. The assignments were kept in sealed envelopes till data
      analysis. The randomization and allocation process were done by a higher nursing staff
      blinded to the study. Throughout the study, the medical staff, and parents were blind to
      assignments.

      All patients were hospitalized and received treatment. The treatment consisted of intravenous
      fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized
      adrenaline or salbutamol was added in severe cases according to the decision of a senior
      pediatrician. The validated clinical score for acute bronchiolitis were taken after a period
      of adjustment of at least 5 min and with the child quiet, not crying, without fever, and
      breathing room air. Respiratory rate were determined by observation of the thoracic movement
      over a full minute. The degree of accessory muscle use was based on the degree of intercostal
      or subcostal retraction. Physical examination as well as clinical severity score was recorded
      for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers
      of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D
      supplementation at dose 400 IU per day

      All patients were submitted to careful history taking, complete clinical examination and the
      following laboratory investigations.

        -  Complete blood count

        -  Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of
           patients in the randomized trial.

      Venous blood samples were collected from every subject by sterile venipuncture using
      disposable syringes. Each sample was then distributed as follows:

        1. One ml of blood was disposed into a plastic tube containing EDTA solution for performing
           complete blood count using electronic cell counter (sysmex kx-21,Japon).

        2. |Two ml blood was delivered into plain tube and centrifuged to obtain a clear non
           hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens
           were stored at - 20 until the time of the analysis. The serum 25 (OH) D levels were
           measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis; Placebo supplementation during acute episode of bronchiolitis
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute bronchiolitis; Vitamin D; Modified Tal score; Randomized; Controlled trial