Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric Primary Care.
Condition: Recurrent Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D
      supplementation in children with RRI, with no conclusive information.

      Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate
      whether oral supplementation with vitamin D from October to April reduces the global health
      burden of recurrent respiratory tract infections in a primary care setting.

      The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can
      reduce the number of respiratory tract infections in children diagnosed with recurrent
      respiratory tract infections the seasons before.

      Secondary objectives was the assessment of Vitamin D supplementation benefits on global
      socioeconomic burden of recurrent respiratory tract infections in a primary care setting,
      according to number of visits to the primary care paediatrician and use of antibiotics due to
      respiratory tract infections.
    

Detailed description: 
      The University study personnel randomly allocated patients to receive, from October to March,
      a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) or
      not.

      Randomization was performed using a free web-based service that offers random assignment;
      patients were randomized considering gender and age class (up to 12 months; beyond 1 years).
      The primary care practitioner was blinded regarding the study group allocation.

      Inclusion criteria were: a) patients diagnosed the seasons before with: ≥ 6 respiratory
      infections per annum OR ≥ 1 respiratory infections per month involving the upper airways from
      September to April OR ≥ 3 respiratory infections per annum involving the lower airways. b)
      patients with no findings suggestive of an immunodeficiency on history and physical
      examination.

      From the recruitment, parents recorded number and type of diagnosed respiratory tract
      infections, number of ambulatory visits, use of antibiotics and duration of symptoms in a
      structured diary.

      Upper Respiratory Tract Infections (URTIs) comprehends diagnosis of acute otitis media, acute
      rhinosinusitis and acute pharyngotonsillitis. Lower Respiratory Tract Infections (LRTIs)
      comprehend diagnosis of bronchiolitis and pneumonia.

      All parents had a close telephone contact to help them in the diary compilation. Adverse
      events related to the protocol were monitored. Missing data were recovered through the
      information system of the primary care practitioner.

      Quantitative data were expressed as mean and standard deviation. To compare the mean between
      the two groups, Student's t-test for unpaired was used. The frequency of each visits to the
      pediatricians and use of antibiotics in the two group was calculated and expressed as a
      percentage. The χ² test was used to compare the percentages between the two groups. For all
      tests, P-values <0.05 were considered significant.

      Since Italian National Health System covers all costs for pediatrician visits and
      antibiotics, cost assessment was made analysing the costs regarding the frequency of each
      parameters in treated and nontreated group. We considered as direct cost National Health
      System: Medical examination (20,66 euros for each examination, as provided by the Italian
      Ministry of Health) and use of Antibiotics (the cost was as in the list of the National Drug
      Authority).
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention