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

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ClinicalTrials.gov Identifier: NCT01222273
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joseph Pilewski, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis
Intervention: Dietary Supplement: cholecalciferol (Vitamin D3)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The CF Foundation patient registry will be queried for patients meeting inclusion/exclusion criteria. A recruitment letter will be sent to these patients. Additionally, patients/parents of patients will be approached regarding study participation by the investigator at routine clinic visits.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cholecalciferol

2000 Units of cholecalciferol once daily

cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months


Participant Flow:   Overall Study
    Cholecalciferol
STARTED   7 
COMPLETED   7 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with CF with a prior history of clinically diagnosed ABPA

Reporting Groups
  Description
Cholecalciferol

2000 Units of cholecalciferol once daily

cholecalciferol (Vitamin D3): 4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months


Baseline Measures
   Cholecalciferol 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   7 
<=18 years      2  28.6% 
Between 18 and 65 years      5  71.4% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   7 
   21.91  (2.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   7 
Female      4  57.1% 
Male      3  42.9% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   7 
United States   7 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 
Participants Analyzed   7 
   22.5  (10.68) 
IgE 
[Units: IU/mL]
Mean (Standard Deviation)
 
Participants Analyzed   7 
   344.6  (284.9) 
Asp IgE 
[Units: kUA/I]
Mean (Standard Deviation)
 
Participants Analyzed   7 
   18.4  (14.7) 
Genotype 
[Units: Participants]
Count of Participants
 
Participants Analyzed   7 
ΔF508/R553X      1  14.3% 
ΔF508/612+ 1G-T      1  14.3% 
neg/ΔF508      1  14.3% 
ΔF508/ΔF508      1  14.3% 
MEG/G542X      1  14.3% 
ΔF508/1213delT      1  14.3% 
ΔF508/R1162X      1  14.3% 


  Outcome Measures

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

2.  Secondary:   Change in Patient Total IgE Levels   [ Time Frame: 6 months ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joseph M. Pilewski, MD
Organization: Children’s Hospital of Pittsburgh of UPMC
phone: (412) 692-2164
e-mail: pilewskijm@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Pilewski, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01222273     History of Changes
Other Study ID Numbers: PRO09090370
7P50HL084932-04 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2010
First Posted: October 18, 2010
Results First Submitted: November 9, 2017
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018