Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
|Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis||Dietary Supplement: cholecalciferol (Vitamin D3)||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis|
- Aspergillus induced IL-13 responses in CD4+ T-cells [ Time Frame: 6 months ]To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce Aspergillus induced IL-13 responses in CD4+ T-cells.
- 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 ]To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce total and aspergillus specific IgE levels
|Study Start Date:||September 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
2000 Units of cholecalciferol once daily
Dietary Supplement: cholecalciferol (Vitamin D3)
4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months
Other Name: cholecalciferol
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 lungs, but some patients respond with an allergic reaction that causes them to wheeze, cough, or have difficulty breathing. This allergic reaction is called ABPA. Current treatment for ABPA includes high dose steroids and an "anti-fungal" medicine. Treatment with steroids may be problematic for some people due to its side effects on blood sugar levels and the bones. Steroids are medications that decrease inflammation, including prednisone, medrol, dexamethasone and others.
Ongoing research at UPMC on the study "Mechanisms of Immune Tolerance in ABPA" has studied people with CF and ABPA versus those patients with CF that just grow A. fumigatus (Af) in the sputum, but do not have ABPA. You may have participated in this study. This study has shown that people with CF with the fungus, Af, in their sputum but who do not have ABPA have more of a certain type of cell in their blood that helps the body to regulate or suppress allergic reactions than those people with CF and ABPA.
Recent studies have demonstrated that Vitamin D is a critical factor in the development of these cells that suppress allergic reactions. People with CF, due to their pancreatic insufficiency that causes them to have difficulty absorbing fat, also have lower levels of the fat soluble vitamins which include vitamin D. In the study done at UPMC, "Mechanisms of Immune Tolerance in ABPA", people with CF and ABPA had significantly lower vitamin D levels than people with CF who did not have ABPA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222273
|United States, Pennsylvania|
|Comprehensive Lung Center - Falk Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Joseph M Pilewski, MD||University of Pittsburgh|
|Study Director:||Jay K Kolls, MD||University of Pittsburgh|