Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01222273|
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis||Dietary Supplement: cholecalciferol (Vitamin D3)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
open label Vitamin D
Dietary Supplement: cholecalciferol (Vitamin D3)
4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months
Other Name: cholecalciferol
- Number of Participants With 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 peripheral CD4+ T-cells. Response confirmed for each individual patient and recorded as number of participants with response.
- Change in Patient Total IgE Levels [ Time Frame: 6 months ]To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce total IgE levels by the end of the 24-week period
- Change in Patient Aspergillus Specific IgE Levels [ Time Frame: 6 months ]To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce aspergillus specific IgE levels by the end of the 24-week period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|