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Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma (VIDA)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01248065
First received: November 24, 2010
Last updated: July 23, 2014
Last verified: July 2014
Results First Received: June 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Vitamin D3
Drug: Ciclesonide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ciclesonide + Placebo Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Ciclesonide + Vitamin D

Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)


Participant Flow:   Overall Study
    Ciclesonide + Placebo   Ciclesonide + Vitamin D
STARTED   207   201 
COMPLETED   181 [1]   179 [2] 
NOT COMPLETED   26   22 
Lost to Follow-up                3                5 
Withdrawal by Subject                14                11 
Adverse Event                3                0 
Third treatment failure event                3                1 
Other                3                5 
[1] All 207 participants were included in the primary time-to-event analysis.
[2] All 201 participants were included in the primary time-to-event analysis.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Ciclesonide + Placebo Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Ciclesonide + Vitamin D

Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Total Total of all reporting groups

Baseline Measures
   Ciclesonide + Placebo   Ciclesonide + Vitamin D   Total 
Overall Participants Analyzed 
[Units: Participants]
 207   201   408 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (12.7)   39.9  (13.1)   39.7  (12.9) 
Gender 
[Units: Participants]
     
Female   141   137   278 
Male   66   64   130 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian/Pacific Islander   7   7   14 
Black   68   63   131 
White   111   105   216 
Hispanic   19   20   39 
Other   2   6   8 
Duration of asthma 
[Units: Years]
Mean (Standard Deviation)
 25.0  (12.8)   24.9  (13.5)   25.0  (13.2) 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.5  (9.5)   32.0  (8.2)   31.8  (8.9) 
Symptom score (morning) 
[Units: Avg score of 5 sx: 0=absent to 3=severe]
Mean (Standard Deviation)
 0.41  (0.36)   0.41  (0.34)   0.41  (0.35) 
Symptom score (afternoon and evening) 
[Units: Avg score of 5 sx: 0=absent to 3=severe]
Mean (Standard Deviation)
 0.43  (0.40)   0.44  (0.35)   0.43  (0.37) 
Level of 25-hydroxyvitamin D 
[Units: ng/mL]
Median (Inter-Quartile Range)
 18.8 
 (13.4 to 23.7) 
 19.9 
 (14.5 to 25.0) 
 19.2 
 (13.9 to 24.3) 
FEV1 before albuterol use (L) 
[Units: Liters]
Mean (Standard Deviation)
 2.62  (0.83)   2.63  (0.78)   2.63  (0.80) 
FEV1 before albuterol use (% predicted) 
[Units: % predicted]
Mean (Standard Deviation)
 80.5  (14.2)   80.7  (13.8)   80.6  (14.0) 
Methacholine PC20 (mg/mL) 
[Units: mg/mL]
Geometric Mean (Standard Deviation)
 1.85  (1.67)   2.05  (1.61)   1.95  (1.65) 
Sputum eosinophils (%) 
[Units: % of eosinophils]
Median (Inter-Quartile Range)
 0.40 
 (0 to 1.30) 
 0.30 
 (0 to 1.30) 
 0.40 
 (0 to 1.30) 


  Outcome Measures
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1.  Primary:   Treatment Failure   [ Time Frame: Twenty-eight week intervention period from randomization until end of trial. ]

2.  Secondary:   Lung Function Change From Baseline   [ Time Frame: Change is measured as value at 28 weeks minus baseline value. ]

3.  Secondary:   Exacerbations   [ Time Frame: Overall exacerbation rate during 28-week trial ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tonya S. King, PhD
Organization: Penn State University Dept. of Public Health Sciences
phone: 717-531-7178
e-mail: tking@psu.edu


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

Responsible Party: dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01248065     History of Changes
Other Study ID Numbers: AsthmaNet 001
1U10HL098115 ( US NIH Grant/Contract Award Number )
Study First Received: November 24, 2010
Results First Received: June 18, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government