Status:
COMPLETED
Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to make their blood levels of the vitamin higher, will reduce the allergic response in their body and make the sy...
Detailed Description
Many patients with cystic fibrosis (CF) cough up mucus or have throat cultures that grow a common fungus called Aspergillus. In patients with CF, aspergillus is not known to cause direct damage to the...
Eligibility Criteria
Inclusion
- Male or female ≥ 12 years of age at enrollment
- Confirmed diagnosis of CF based on the following criteria:
- One or more clinical features consistent with the CF phenotype AND (b or c)
- Positive sweat chloride \> 60 mEq/liter (by pilocarpine iontophoresis)
- two identifiable mutations consistent with CF
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Clinically stable at enrollment as assessed by the site investigator
- Past or present respiratory culture positive for Aspergillus fumigatus
- IgE ≥ 250 and/or presence of class II or higher aspergillus specific IgE on enrollment
- Ability to comply with medication use, study visits and study procedures as judged by the site investigator -
Exclusion
- 1\. Systemic corticosteroids (1 mg/kg if \< 20 kg or \> 20 mg of prednisone per day),.
- 2\. Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening
- a. Serum Calcium \> 11 mg/dl b. 25(OH) D \> 50 ng/ml at screening. c. Creatinine ≥ 1.5, or estimated GFR \<60 by Cockcroft-Gault or MDRD equation. d. LFT≥ 3xULN
- 4\. History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection.
- 9\. Undergoing therapy for non-tuberculous mycobacterial infection
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01222273
Start Date
September 1 2010
End Date
September 1 2013
Last Update
March 29 2018
Active Locations (2)
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1
Comprehensive Lung Center - Falk Clinic
Pittsburgh, Pennsylvania, United States, 15213
2
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224