Effects of an antioxidant-enriched multivitamin in cystic fibrosis

Scott D. Sagel, Umer Khan, Raksha Jain, Gavin Graff, Cori L. Daines, Jordan M. Dunitz, Drucy Borowitz, David M. Orenstein, Ibrahim Abdulhamid, Julie Noe, John P. Clancy, Bonnie Slovis, Michael J. Rock, Karen S. McCoy, Steven Strausbaugh, Floyd R. Livingston, Konstantinos A. Papas, Michele L. Shaffer

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

treated and control groups. Systemic antioxidant (b-carotene, coenzyme Q10, g-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).

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 (b-carotene, coenzyme Q10, g-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).

Original languageEnglish (US)
Pages (from-to)639-647
Number of pages9
JournalAmerican journal of respiratory and critical care medicine
Volume198
Issue number5
DOIs
StatePublished - Sep 1 2018

Keywords

  • Antioxidant
  • Cystic fibrosis
  • Inflammation
  • Oxidative stress
  • Pulmonary exacerbation

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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    Sagel, S. D., Khan, U., Jain, R., Graff, G., Daines, C. L., Dunitz, J. M., Borowitz, D., Orenstein, D. M., Abdulhamid, I., Noe, J., Clancy, J. P., Slovis, B., Rock, M. J., McCoy, K. S., Strausbaugh, S., Livingston, F. R., Papas, K. A., & Shaffer, M. L. (2018). Effects of an antioxidant-enriched multivitamin in cystic fibrosis. American journal of respiratory and critical care medicine, 198(5), 639-647. https://doi.org/10.1164/rccm.201801-0105OC