Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
Completed · Not applicable
Conditions studied: Cystic Fibrosis, Allergic Bronchopulmonary Aspergillosis
In brief
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 symptoms caused by ABPA better.
Key facts
- Study ID
- NCT01222273
- Run by
- University of Pittsburgh
- People needed
- 7
- Starts
- 2010-09-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2018-03-29
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 -
You may not qualify if…
- 1. Systemic corticosteroids (1 mg/kg if < 20 kg or > 20 mg of prednisone per day),.
- 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
- 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.
- Undergoing therapy for non-tuberculous mycobacterial infection
Where it is running
- Comprehensive Lung Center - Falk Clinic — Pittsburgh, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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