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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)
Enrollment 7
Recruitment Details 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  
Arm/Group Title Cholecalciferol
Hide Arm/Group Description

2000 Units of cholecalciferol once daily

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

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Cholecalciferol
Hide Arm/Group Description

2000 Units of cholecalciferol once daily

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

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Subjects with CF with a prior history of clinically diagnosed ABPA
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
2
  28.6%
Between 18 and 65 years
5
  71.4%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
21.91  (2.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 7 participants
22.5  (10.68)
IgE  
Mean (Standard Deviation)
Unit of measure:  IU/mL
Number Analyzed 7 participants
344.6  (284.9)
Asp IgE  
Mean (Standard Deviation)
Unit of measure:  kUA/I
Number Analyzed 7 participants
18.4  (14.7)
Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
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%
1.Primary Outcome
Title Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol
Hide Arm/Group Description:

2000 Units of cholecalciferol once daily

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

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
2.Secondary Outcome
Title Change in Patient Total IgE Levels
Hide Description 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
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol
Hide Arm/Group Description:

2000 Units of cholecalciferol once daily

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

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: IU/mL
312.6  (77.66)
3.Secondary Outcome
Title Change in Patient Aspergillus Specific IgE Levels
Hide Description 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
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholecalciferol
Hide Arm/Group Description:

2000 Units of cholecalciferol once daily

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

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: kUA/I
11.73  (3.581)
Time Frame 6 months
Adverse Event Reporting Description same as clinicaltrials.gov definitions
 
Arm/Group Title Cholecalciferol
Hide Arm/Group Description

2000 Units of cholecalciferol once daily

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

All-Cause Mortality
Cholecalciferol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cholecalciferol
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cholecalciferol
Affected / at Risk (%)
Total   0/7 (0.00%) 
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
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