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Study Name: Pilot Study of Zinc Supplementation in Children with CF
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Griffin, Ian

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Zinc
Number of Participants Being Recruited: 36
Single / Multi-Center: Single Center
STUDY BACKGROUND INFORMATION:
This study will examine the level of zinc absorption, excretion, and balance in children with cystic fibrosis. Zinc is important for many biological functions and is found in a wide variety of foods including beans, nuts, red meat, and poultry. A deficiency of zinc can lead to various conditions including diarrhea, slowed growth, and a weakened immune system.

Researchers would like to find out if children with CF who are given zinc supplements will have a higher zinc balance than CF children who do not take these supplements. In addition, zinc balance will be compared between children that have CF and those that do not. To date, few studies have measured zinc absorption in children with CF.

Half of the children will be given supplements while the other half will receive an identical-appearing placebo.
ELIGIBILITY
Age: 8 Years - 14 Years
FEV1: Not Applicable
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: Hawthorne, Keli
(713) 798-7085
kelih@bcm.tmc.edu
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00104494?term=zinc+and+cystic+fibrosis&rank=1
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.
TX
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
        Email: nxschaap@texaschildrens.org
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