Status:
COMPLETED
Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study)
Lead Sponsor:
Emory University
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Respiratory Tract Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is determine if high-dose vitamin D supplementation improves clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who are admitted to the ...
Detailed Description
Patients with Cystic Fibrosis (CF) have a shorter life span than the general population due to complications with lung infections, which eventually progress to lung failure. New research has suggested...
Eligibility Criteria
Inclusion
- Adult and adolescent CF patients
- age \>16 years
- admitted to the inpatient hospital setting for a pulmonary exacerbation of cystic fibrosis
- enrolled within 72 hours of admission
- able to tolerate oral medications
- expected to survive hospitalization
Exclusion
- Inability to obtain or declined informed consent from the subject and/or legally authorized representative
- History of serum 25(OH)D \>55 ng/mL in the past 12 months
- History of serum 25(OH)D \<10 ng/mL in the past 12 months
- Current intake of more than 2,000 IU of vitamin D
- intake of 2,000 IU of vitamin D or its equivalent weekly dose (14,000 IU) for more than 1 week at any time within the past 60 days or intake of greater than vitamin D 10,000 IU once at anytime in the past 60 days
- Pregnancy or plans to become pregnant during the course of the study (12 months)
- History of disorders associated with hypercalcemia including parathyroid disease
- Current hypercalcemia (albumin-corrected serum calcium \>10.8 mg/dL or ionized calcium \>5.2 mg/dL)
- History of nephrolithiasis
- Chronic kidney disease worse than stage III (\<60 ml/min)
- Oral or intravenous glucocorticoid use currently or in the past month
- History of lung transplantation or awaiting lung transplant
- patient in hospice care
- FEV1% predicted \<20%
- Current significant hepatic dysfunction total bilirubin \> 2.5 mg/dL with direct bilirubin \> 1.0 mg/dL
- Current use of cytotoxic or immunosuppressive drugs
- History of AIDS
- History of illicit drug abuse (defined as history of enrollment into a drug rehabilitation program or hospital visits due to drug use within the past 3 years or any use of the following drugs in the past 6 months (cocaine, opiates, amphetamines, marijuana) or any positive toxicology screen for (cocaine, opiates, amphetamines, marijuana)
- Previous enrollment in the study
- Current enrollment in another intervention trial
- Too ill to participate in study based on investigator's or study team's opinion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01426256
Start Date
October 1 2011
End Date
July 1 2017
Last Update
July 13 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Emory Hospital
Atlanta, Georgia, United States, 30322
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
University of Cincinnati
Cincinnati, Ohio, United States, 45267