CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis

Study design (if review, criteria of inclusion for studies)

Multicenter, double-blind, placebo-controlled, clinical trial.

Participants

91 adults with CF during an acute pulmonary exacerbation

Interventions

Patients were randomly assigned to oral vitamin D3 given as a single dose of 250,000 International Units (IU) or to placebo within 72 h of hospital admission for an acute pulmonary exacerbation, followed by 50,000 IU of vitamin D3 or an identically matched placebo pill taken orally every other week starting at 3 mo after random assignment.

Outcome measures

The primary outcome was the composite endpoint of the time to next pulmonary exacerbation or death within 1 y. The secondary outcomes included circulating concentrations of the antimicrobial peptide cathelicidin and recovery of lung function as assessed by the percentage of predicted forced expiratory volume in 1 s (FEV1%).

Main results

There were no differences between the vitamin D3 and placebo groups in time to next pulmonary exacerbation or death at 1 y. In addition, there were no differences in serial recovery of lung function after pulmonary exacerbation by FEV1% or in serial concentrations of plasma cathelicidin.

Authors' conclusions

Vitamin D3 initially given at the time of pulmonary exacerbation of CF did not alter the time to the next pulmonary exacerbation, 12-mo mortality, serial lung function, or serial plasma cathelicidin concentrations.

Keywords: Bone Density Conservation Agents; Bone Diseases; Gastrointestinal Diseases; Pancreas insufficiency; Pancreatic Diseases; pharmacological_intervention; Supplementation; vitamins; Vitamin D; Vitamin D Deficiency; Vitamin deficiencies; Malabsorption;