title: Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study.
abstract: BACKGROUND
  Low serum levels of 25-hydroxyvitamin D(3) are associated with an increased risk of respiratory tract infections (RTIs). Clinical trials with vitamin D(3) against various infections have been carried out but data are so far not conclusive. Thus, there is a need for additional randomised controlled trials of effects of vitamin D(3) on infections.
  
  
  OBJECTIVE
  To investigate if supplementation with vitamin D(3) could reduce infectious symptoms and antibiotic consumption among patients with antibody deficiency or frequent RTIs.
  
  
  METHODS
  A double-blind randomised controlled trial.
  
  
  METHODS
  Karolinska University Hospital, Huddinge.
  
  
  METHODS
  140 patients with antibody deficiency (selective IgA subclass deficiency, IgG subclass deficiency, common variable immune disorder) and patients with increased susceptibility to RTIs (>4 bacterial RTIs/year) but without immunological diagnosis.
  
  
  METHODS
  Vitamin D(3) (4000 IU) or placebo was given daily for 1 year.
  
  
  METHODS
  The primary endpoint was an infectious score based on five parameters: symptoms from respiratory tract, ears and sinuses, malaise and antibiotic consumption. Secondary endpoints were serum levels of 25-hydroxyvitamin D(3), microbiological findings and levels of antimicrobial peptides (LL-37, HNP1-3) in nasal fluid.
  
  
  RESULTS
  The overall infectious score was significantly reduced for patients allocated to the vitamin D group (202 points) compared with the placebo group (249 points; adjusted relative score 0.771, 95% CI 0.604 to 0.985, p=0.04).
  
  
  CONCLUSIONS
  A single study centre, small sample size and a selected group of patients. The sample size calculation was performed using p=0.02 as the significance level whereas the primary and secondary endpoints were analysed using the conventional p=0.05 as the significance level.
  
  
  CONCLUSIONS
  Supplementation with vitamin D(3) may reduce disease burden in patients with frequent RTIs.
authors.affiliation: Department of Laboratory Medicine, Clinical Microbiology,  Karolinska Institutet, Stockholm,  Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Bergman
authors.forename: Anna-Carin
authors.initials: AC
authors.lastname: Norlin
authors.forename: Susanne
authors.initials: S
authors.lastname: Hansen
authors.forename: Rokeya Sultana
authors.initials: RS
authors.lastname: Rekha
authors.forename: Birgitta
authors.initials: B
authors.lastname: Agerberth
authors.forename: Linda
authors.initials: L
authors.lastname: Björkhem-Bergman
authors.forename: Lena
authors.initials: L
authors.lastname: Ekström
authors.forename: Jonatan D
authors.initials: JD
authors.lastname: Lindh
authors.forename: Jan
authors.initials: J
authors.lastname: Andersson