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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01222273
• Date of registration: 14/10/2010
• Prospective Registration: No
• 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: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01222273
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jay K Kolls, MD
• Affiliation: University of Pittsburgh

• 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: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Allergic Bronchopulmonary Aspergillosis

Cystic Fibrosis

Intervention(s)

Dietary Supplement: cholecalciferol (Vitamin D3)

Primary Outcome(s)

Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells [Time Frame: 6 months]

Secondary Outcome(s)

Change in Patient Aspergillus Specific IgE Levels [Time Frame: 6 months]

Change in Patient Total IgE Levels [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)

Results

• Results available: Yes
• Date Posted: 29/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01222273