Evidence map›Paper›PMID 29688760›Full record

Trial reportAmerican journal of respiratory and critical care medicine2018

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

Scott D Sagel, Umer Khan, Raksha Jain, Gavin Graff, Cori L Daines, Jordan M Dunitz, Drucy Borowitz, David M Orenstein, Ibrahim Abdulhamid, Julie Noe and 8 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01859390 (A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01859390 phase2completednot on this map

A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients

TypeinterventionalSponsorUniversity of Colorado, DenverRan2013 to 2016Enrolled73ConditionsCystic FibrosisArmsAquADEKs-2, control multivitamin
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Guideline
  2. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Update on the management of vitamins and minerals in cystic fibrosis.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2022
    Review
  13. Review
  14. Article
  15. Cystic Fibrosis and Oxidative Stress: The Role of CFTR.Molecules (Basel, Switzerland) · 2022
    Review
  16. Article
  17. Article
  18. Brazilian Guidelines for Nutrition in Cystic Fibrosis.Einstein (Sao Paulo, Brazil) · 2022
    Article
  19. Review
  20. Evaluation of airway and circulating inflammatory biomarkers for cystic fibrosis drug development.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 17 institutions in 1 country.

Scott D Sagel1 Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.ORCID 0000-0001-6172-4465
Umer Khan2 Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington.
Raksha Jain3 Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
Gavin Graff4 Department of Pediatrics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
Cori L Daines5 Department of Pediatrics, University of Arizona, Tucson, Arizona.
Jordan M Dunitz6 Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
Drucy Borowitz7 Department of Pediatrics, Jacobs School of Medicine, University at Buffalo, Buffalo, New York.
David M Orenstein8 Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Ibrahim Abdulhamid9 Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan.
Julie Noe10 Department of Pediatrics, Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, Wisconsin.
John P Clancy11 Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Bonnie Slovis12 Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.
Michael J Rock13 Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Karen S McCoy14 Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.
Steven Strausbaugh15 Department of Medicine, Rainbow Babies and Children's Hospital, Cleveland, Ohio.
Floyd R Livingston16 Department of Pediatrics, Nemours Children's Hospital, Orlando, Florida.
Konstantinos A Papas17 Callion Pharma, Jonesborough, Tennessee and.
Michele L Shaffer18 Department of Statistics, University of Washington, Seattle, Washington.
Children's Hospital Colorado · USChildren's Hospital of Michigan · USChildren's Hospital of Pittsburgh · USChildren's Hospital of Wisconsin · USCincinnati Children's Hospital Medical Center · USCystic Fibrosis Foundation · USNationwide Children's Hospital · USNemours Children's Clinic · USPenn State Milton S. Hershey Medical Center · USRainbow Babies & Children's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity at Buffalo, State University of New York · USUniversity of Arizona · USUniversity of Minnesota · USUniversity of Washington · USUniversity of Wisconsin–Madison · USVanderbilt University Medical Center · US

Funding

NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR002535
6 · The paper itself

Abstract

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

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

methodsIn this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic-insufficient subjects with CF 10 years of age and older with an FEV MEASUREMENTS AND MAIN

resultsChange 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.

conclusionsAntioxidant 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).

Indexed as

Dietary SupplementsAdministration, OralAdolescentAdultAntioxidantsChildCystic FibrosisDouble-Blind MethodFemaleHumansInflammationMaleMalnutritionOxidative StressVitaminsYoung AdultAntioxidantsVitaminsantioxidantcystic fibrosisinflammationoxidative stresspulmonary exacerbation

Identifiers

PMID29688760
PMCPMC6118015
OpenAlexW2801358743

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.