Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01222273
• Date of registration: 14/10/2010
• Primary sponsor: University of Pittsburgh
• Public title: Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
• Scientific title: Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
• Date of first enrolment: September 2010
• Target sample size: 15
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01222273
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Elizabeth Hartigan, MPH, RN, CRM

• Name: Jay K Kolls, MD
• Affiliation: Louisiana State University Health Sciences Center in New Orleans

• Name: Joseph M Pilewski, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female = 12 years of age at enrollment

2. Confirmed diagnosis of CF based on the following criteria:

1. One or more clinical features consistent with the CF phenotype AND (b or c)

2. Positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis)

3. two identifiable mutations consistent with CF

3. 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.

4. Clinically stable at enrollment as assessed by the site investigator

5. Past or present respiratory culture positive for Aspergillus fumigatus

6. IgE = 250 and/or presence of class II or higher aspergillus specific IgE on
enrollment

7. Ability to comply with medication use, study visits and study procedures as judged by
the site investigator -

Exclusion Criteria:

- 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

A. Fumigatus

Allergic Bronchopulmonary Aspergillosis

Cystic Fibrosis

Intervention(s)

Dietary Supplement: cholecalciferol (Vitamin D3)

Primary Outcome(s)

Aspergillus induced IL-13 responses in CD4+ T-cells [Time Frame: 6 months]

Secondary Outcome(s)

Total IgE, Aspergillus specific IgE and IgG levels, vitamin D levels, FEV1, cytokine production by Aspergillus stimulated peripheral blood T cells, urine calcium/creatinine ratio [Time Frame: 6 months]

Secondary ID(s)

7P50HL084932-04

PRO09090370

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)