Vin Tangpricha1,2,3,4, Joshua Lukemire5, Yuqing Chen5, José Nilo G Binongo5, Suzanne E Judd6, Ellen S Michalski1,2, Moon J Lee1, Seth Walker3, Thomas R Ziegler1,2,3,4, Rabin Tirouvanziam3,7, Susu M Zughaier8, Supavit Chesdachai1, Wendy A Hermes1, James F Chmiel9, Ruth E Grossmann10, Amit Gaggar11, Patricia M Joseph12, Jessica A Alvarez1,2,3. 1. Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, GA. 2. Nutrition Health Sciences Program, Emory University School of Public Health, Atlanta, GA. 3. Emory Cystic Fibrosis Center, Atlanta, GA. 4. Atlanta VA Medical Center, Atlanta, GA. 5. Emory Rollins School of Public Health. 6. Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL. 7. Division of Pulmonary, Allergy & Immunology, Cystic Fibrosis, and Sleep, Department of Pediatrics, Emory University, Atlanta, GA. 8. College of Medicine, Qatar University, Doha, Qatar. 9. Department of Pediatrics, Case Western Reserve University School of Medicine, Rainbow Babies and Children's Hospital, Cleveland, OH. 10. College of Nursing, University of Iowa, Iowa City, IA. 11. Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, The University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, AL. 12. Division of Pulmonary, Critical Care & Sleep, Department of Medicine, University of Cincinnati, Cincinnati, OH.
Abstract
BACKGROUND:Patients with cystic fibrosis (CF) have increased risk of vitamin D deficiency owing to fat malabsorption and other factors. Vitamin D deficiency has been associated with increased risk of pulmonary exacerbations of CF. OBJECTIVES: The primary objective of this study was to examine the impact of a single high-dose bolus of vitamin D3 followed by maintenance treatment given to adults with CF during an acute pulmonary exacerbation on future recurrence of pulmonary exacerbations. METHODS: This was a multicenter, double-blind, placebo-controlled, intent-to-treat clinical trial. Subjects with CF 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. 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%). RESULTS:A total of 91 subjects were enrolled in the study. 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. 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. This trial was registered at clinicaltrials.gov as NCT01426256.
RCT Entities:
BACKGROUND:Patients with cystic fibrosis (CF) have increased risk of vitamin Ddeficiency owing to fat malabsorption and other factors. Vitamin Ddeficiency has been associated with increased risk of pulmonary exacerbations of CF. OBJECTIVES: The primary objective of this study was to examine the impact of a single high-dose bolus of vitamin D3 followed by maintenance treatment given to adults with CF during an acute pulmonary exacerbation on future recurrence of pulmonary exacerbations. METHODS: This was a multicenter, double-blind, placebo-controlled, intent-to-treat clinical trial. Subjects with CF 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. 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%). RESULTS: A total of 91 subjects were enrolled in the study. 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. 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. This trial was registered at clinicaltrials.gov as NCT01426256.
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