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Am J Respir Crit Care Med. 2018 Sep 1;198(5):639-647. doi: 10.1164/rccm.201801-0105OC.

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial.

Author information

1
1 Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.
2
2 Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington.
3
3 Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
4
4 Department of Pediatrics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
5
5 Department of Pediatrics, University of Arizona, Tucson, Arizona.
6
6 Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
7
7 Department of Pediatrics, Jacobs School of Medicine, University at Buffalo, Buffalo, New York.
8
8 Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
9
9 Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan.
10
10 Department of Pediatrics, Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin.
11
11 Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
12
12 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.
13
13 Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
14
14 Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.
15
15 Department of Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.
16
16 Department of Pediatrics, Nemours Children's Hospital, Orlando, Florida.
17
17 Callion Pharma, Jonesborough, Tennessee and.
18
18 Department of Statistics, University of Washington, Seattle, Washington.

Abstract

RATIONALE:

Cystic fibrosis (CF) is characterized by dietary antioxidant deficiencies, which may contribute to an oxidant-antioxidant imbalance and oxidative stress.

OBJECTIVES:

Evaluate the effects of an oral antioxidant-enriched multivitamin supplement on antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes.

METHODS:

In this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic-insufficient subjects with CF 10 years of age and older with an FEV1 between 40% and 100% predicted were randomized to 16 weeks of an antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment. Endpoints included systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety, and tolerability.

MEASUREMENTS AND MAIN RESULTS:

Change in sputum myeloperoxidase concentration over 16 weeks, the primary efficacy endpoint, was not significantly different between the treated and control groups. Systemic antioxidant (β-carotene, coenzyme Q10, γ-tocopherol, and lutein) concentrations significantly increased in the antioxidant-treated group (P < 0.001 for each), whereas circulating calprotectin and myeloperoxidase decreased in the treated group compared with the control group at Week 4. The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio, 0.50; P = 0.04). Lung function and growth endpoints did not differ between groups. Adverse events and tolerability were similar between groups.

CONCLUSIONS:

Antioxidant supplementation was safe and well tolerated, resulting in increased systemic antioxidant concentrations and modest reductions in systemic inflammation after 4 weeks. Antioxidant treatment was also associated with a lower risk of first pulmonary exacerbation. Clinical trial registered with www.clinicaltrials.gov (NCT01859390).

KEYWORDS:

antioxidant; cystic fibrosis; inflammation; oxidative stress; pulmonary exacerbation

PMID:
29688760
PMCID:
PMC6118015
[Available on 2019-09-01]
DOI:
10.1164/rccm.201801-0105OC

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