Study design (if review, criteria of inclusion for studies)
Randomized, placebo-controlled, double-blinded pilot study
Participants
Thirty adults with CF (hospital admission for a pulmonary exacerbation)
Interventions
250,000 IU cholecalciferol or placebo within 48 h of hospital admission for a pulmonary exacerbation.
Outcome measures
Concentrations of 25-hydroxyvitamin D (25(OH)D), clinical outcomes and potential adverse events were assessed up to one year after randomization. Survival.
Main results
Data from all subjects was analyzed. Serum 25(OH)D concentrations increased from a mean of 30.6 +/- 3.2 ng/mL to 58.1 +/- 3.5 ng/mL (p < 0.001) at one week and 36.7 +/- 2.6 ng/mL by 12 weeks (p = 0.06) in the vitamin D group; in contrast, serum 25(OH)D concentrations remained unchanged in the placebo group. Unadjusted, one-year survival and hospital-free days were increased in the vitamin D group (p = 0.029, p = 0.036; respectively). There was also a trend toward increased IV antibiotic therapy-free days in the vitamin D group (p = 0.073). There were no signs of hypervitaminosis D or adverse events. Serum PTH and calcium concentrations were similar across both groups.
Authors' conclusions
In this pilot study, a single, oral bolus of cholecalciferol increased serum 25(OH)D concentrations and was associated with a trend toward improved clinical outcomes in CF subjects hospitalized for a pulmonary exacerbation. Further investigation is needed into the clinical impact of improved vitamin D status in patients with CF.