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Study Name: Vitamin D for enhancing the immune system in people with CF
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Tangpricha, Vin

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): Vitamin D
Number of Participants Being Recruited: 200
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Vitamin D deficiency is common in people with CF. Vitamin D is important for bone health and research is also looking at the effects of Vitamin D on the immune system. This trial will look at the effect on the immune system of people with CF when receiving a one time dose of Vitamin D3 (cholecalciferol) 250,000 IU (international units) compared to placebo. Study participants must initially be admitted for a CF exacerbation. Specimens of blood, sputum, and urine will be taken throughout the study along with pulmonary function testing. The study will last up to one year.
ELIGIBILITY
Age: >= 16 Years
FEV1: >= 20 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: Tangpricha, Vin
(404) 321-6111 X2080
vin.tangpricha@emory.edu
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01426256?term=vitamin+d+and+cystic+fibrosis&rank=3
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.
AL
  • The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
GA
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
IA
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
        Email: mary-teresi@uiowa.edu
OH
  • 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
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