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Trial record 1 of 3 for:    VIDA asthma
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Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma (VIDA)

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ClinicalTrials.gov Identifier: NCT01248065
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Vitamin D3
Drug: Ciclesonide
Enrollment 408
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D
Hide Arm/Group Description Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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)

Period Title: Overall Study
Started 207 201
Completed 181 [1] 179 [2]
Not Completed 26 22
Reason Not Completed
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.
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D Total
Hide Arm/Group Description Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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 of all reporting groups
Overall Number of Baseline Participants 207 201 408
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 201 participants 408 participants
39.5  (12.7) 39.9  (13.1) 39.7  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 201 participants 408 participants
Female
141
  68.1%
137
  68.2%
278
  68.1%
Male
66
  31.9%
64
  31.8%
130
  31.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 201 participants 408 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 201 participants 408 participants
25.0  (12.8) 24.9  (13.5) 25.0  (13.2)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 207 participants 201 participants 408 participants
31.5  (9.5) 32.0  (8.2) 31.8  (8.9)
Symptom score (morning)  
Mean (Standard Deviation)
Unit of measure:  Avg score of 5 sx: 0=absent to 3=severe
Number Analyzed 207 participants 201 participants 408 participants
0.41  (0.36) 0.41  (0.34) 0.41  (0.35)
Symptom score (afternoon and evening)  
Mean (Standard Deviation)
Unit of measure:  Avg score of 5 sx: 0=absent to 3=severe
Number Analyzed 207 participants 201 participants 408 participants
0.43  (0.40) 0.44  (0.35) 0.43  (0.37)
Level of 25-hydroxyvitamin D  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 207 participants 201 participants 408 participants
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)  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 207 participants 201 participants 408 participants
2.62  (0.83) 2.63  (0.78) 2.63  (0.80)
FEV1 before albuterol use (% predicted)  
Mean (Standard Deviation)
Unit of measure:  % predicted
Number Analyzed 207 participants 201 participants 408 participants
80.5  (14.2) 80.7  (13.8) 80.6  (14.0)
Methacholine PC20 (mg/mL)  
Geometric Mean (Standard Deviation)
Unit of measure:  mg/mL
Number Analyzed 207 participants 201 participants 408 participants
1.85  (1.67) 2.05  (1.61) 1.95  (1.65)
Sputum eosinophils (%)  
Median (Inter-Quartile Range)
Unit of measure:  % of eosinophils
Number Analyzed 207 participants 201 participants 408 participants
0.40
(0 to 1.30)
0.30
(0 to 1.30)
0.40
(0 to 1.30)
1.Primary Outcome
Title Treatment Failure
Hide Description Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.
Time Frame Twenty-eight week intervention period from randomization until end of trial.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D
Hide Arm/Group Description:
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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)

Overall Number of Participants Analyzed 207 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
29
(23 to 35)
28
(21 to 34)
2.Secondary Outcome
Title Lung Function Change From Baseline
Hide Description FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.
Time Frame Change is measured as value at 28 weeks minus baseline value.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D
Hide Arm/Group Description:
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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)

Overall Number of Participants Analyzed 207 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
-0.04
(-0.11 to 0.03)
-0.07
(-0.14 to 0.01)
3.Secondary Outcome
Title Exacerbations
Hide Description Outcome defined as number of exacerbations per person-year.
Time Frame Overall exacerbation rate during 28-week trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D
Hide Arm/Group Description:
Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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)

Overall Number of Participants Analyzed 207 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Exacerbations/person-year
0.40
(0.30 to 0.50)
0.26
(0.18 to 0.33)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ciclesonide + Placebo Ciclesonide + Vitamin D
Hide Arm/Group Description Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

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)

All-Cause Mortality
Ciclesonide + Placebo Ciclesonide + Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ciclesonide + Placebo Ciclesonide + Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/207 (4.35%)      6/201 (2.99%)    
Blood and lymphatic system disorders     
Severe leg pain  1/207 (0.48%)  1 0/201 (0.00%)  0
Gastrointestinal disorders     
Sigmoid diverticulitis with abscess  1/207 (0.48%)  2 0/201 (0.00%)  0
Gastric volvulus causing gastric outlet obstruction  0/207 (0.00%)  0 1/201 (0.50%)  1
General disorders     
Transient ischemic attack  0/207 (0.00%)  0 1/201 (0.50%)  1
Limb edema  1/207 (0.48%)  1 0/201 (0.00%)  0
Infections and infestations     
Acute sinusitis  0/207 (0.00%)  0 1/201 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Initial diagnosis of breast cancer  1/207 (0.48%)  1 0/201 (0.00%)  0
Benign fibroid tumor surgery  0/207 (0.00%)  0 1/201 (0.50%)  1
Psychiatric disorders     
Major depression disorder  1/207 (0.48%)  1 0/201 (0.00%)  0
Post-traumatic stress disorder  0/207 (0.00%)  0 1/201 (0.50%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma exacerbation  3/207 (1.45%)  6 1/201 (0.50%)  1
Skin and subcutaneous tissue disorders     
Allergic reaction/rash  1/207 (0.48%)  1 0/201 (0.00%)  0
Surgical and medical procedures     
Inguinal hernia  0/207 (0.00%)  0 1/201 (0.50%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ciclesonide + Placebo Ciclesonide + Vitamin D
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   157/207 (75.85%)      168/201 (83.58%)    
Gastrointestinal disorders     
Diseases of the digestive system  23/207 (11.11%)  28 13/201 (6.47%)  20
General disorders     
Symptoms, signs, and ill-defined conditions  60/207 (28.99%)  114 59/201 (29.35%)  141
Infections and infestations     
Infectious and parasitic diseases  22/207 (10.63%)  23 12/201 (5.97%)  13
Injury, poisoning and procedural complications     
Injury and poisoning  23/207 (11.11%)  31 28/201 (13.93%)  40
Musculoskeletal and connective tissue disorders     
Diseases of the musculoskeletal system and connective tissue  31/207 (14.98%)  46 29/201 (14.43%)  33
Nervous system disorders     
Diseases of the nervous system and sense organs  25/207 (12.08%)  27 23/201 (11.44%)  30
Renal and urinary disorders     
Diseases of the genitourinary system  18/207 (8.70%)  31 12/201 (5.97%)  12
Respiratory, thoracic and mediastinal disorders     
Diseases of the respiratory system  122/207 (58.94%)  231 137/201 (68.16%)  253
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
Layout table for Results Point of Contact information
Name/Title: Tonya S. King, PhD
Organization: Penn State University Dept. of Public Health Sciences
Phone: 717-531-7178
EMail: tking@psu.edu
Layout table for additonal information
Responsible Party: dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01248065    
Other Study ID Numbers: AsthmaNet 001
1U10HL098115 ( U.S. NIH Grant/Contract )
First Submitted: November 24, 2010
First Posted: November 25, 2010
Results First Submitted: June 18, 2014
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014