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Study Name: AquADEKs-2 - Effects of an Antioxidant-Enriched Multivitamin on Inflammation and Oxidative Stress in people with CF
Study Type: Interventional
Intervention Category: Anti-Inflammatory
Study Sponsor: Sagel, Scott

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 2
Recruitment Status: Recruiting
Study Drug(s): AquADEKs-2
Number of Participants Being Recruited: 80
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to study the effects of an antioxidant-enriched multivitamin supplement on inflammation and oxidative stress in people with CF 10 years of age and older and who are pancreatic insufficient. Specimens of blood, sputum, and urine will be taken during the trial along with pulmonary function testing. The trial will last up to 22 weeks.
ELIGIBILITY
Age: >= 10 Years
FEV1: 40 - 100 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01859390
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AZ
  • Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
    Contact Information:
        Molina de Rodriguez, Osmara
        Phone: (520) 891-6767
        Email: omolina@email.arizona.edu
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
FL
  • Nemours Children's Clinic - Orlando (Pediatric), Orlando, FL, 32806
    Contact Information:
        Price, Angela
        Phone: (407) 650-7634
        Email: alprice@nemours.org
MI
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
MN
  • The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
NY
  • Women and Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
    Contact Information:
        Caci, Nadine
        Phone: (716) 878-7524
        Email: ncaci@upa.chob.edu
OH
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Decker, Beth
        Phone: (513) 803-4325
        Email: Beth.Decker@cchmc.org
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
PA
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
TN
  • Vanderbilt University Medical Center (Adult), Nashville, TN, 37232
    Contact Information:
        Robinette, Michelle
        Phone: (615) 343-9025
        Email: michelle.robinette@vanderbilt.edu
TX
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    Contact Information:
        Keller, Ashley
        Phone: (214) 648-2817
        Email: Ashley.Keller@UTSouthwestern.edu
WI
  • University of Wisconsin (Pediatric), Madison, WI, 53792
    Contact Information:
        Makholm, Linda
        Phone: (608) 262-0340
        Email: Lmakholm@uwhealth.org
  • Children's Hospital of Wisconsin Froedtert & Medical College of Wisconsin (Pediatric), Milwaukee, WI, 53201
    Contact Information:
        Kump, Theresa
        Phone: (414) 337-7144
        Email: tkump@mcw.edu
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