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Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD) (ACViD)

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ClinicalTrials.gov Identifier: NCT02805907
Recruitment Status : Completed
First Posted : June 20, 2016
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Rubén Andújar, MurciaSalud

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma, Bronchial
Interventions Drug: Calcifediol
Drug: Placebo
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Period Title: Overall Study
Started 56 56
Completed 53 53
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             3             3
Arm/Group Title Intervention Group (IG) Control Group (CG) Total
Hide Arm/Group Description

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 56 56 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 56 participants 112 participants
54.57  (15.83) 56.61  (15.00) 55.59  (15.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Female
40
  71.4%
47
  83.9%
87
  77.7%
Male
16
  28.6%
9
  16.1%
25
  22.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
56
 100.0%
56
 100.0%
112
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 56 participants 56 participants 112 participants
56 56 112
Initial Asthma Control Test (ACT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 56 participants 56 participants 112 participants
17.71  (4.54) 19.02  (4.59) 18.37  (4.59)
[1]
Measure Description: Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.
Initial Asthma Quality of Life Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 56 participants 56 participants 112 participants
4.38  (1.62) 4.85  (1.96) 4.62  (1.91)
[1]
Measure Description: The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.
Asthma Severity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Intermitent
5
   8.9%
12
  21.4%
17
  15.2%
Mild Persistent
9
  16.1%
11
  19.6%
20
  17.9%
Moderate Persistent
29
  51.8%
27
  48.2%
56
  50.0%
Severe Persistent
13
  23.2%
6
  10.7%
19
  17.0%
Exacerbations   [1] 
Mean (Standard Deviation)
Unit of measure:  Exacerbations in the last 6 months
Number Analyzed 56 participants 56 participants 112 participants
1.18  (1.55) 1.14  (2.70) 1.16  (2.19)
[1]
Measure Description: Number of exacerbations in the last 6 months
Hospitalizations   [1] 
Mean (Standard Deviation)
Unit of measure:  Hospitalizations in the last 6 months
Number Analyzed 56 participants 56 participants 112 participants
0.11  (0.31) 0.13  (0.33) 0.12  (0.32)
[1]
Measure Description: Number of hospitalizations in the last 6 months
Emergency care   [1] 
Mean (Standard Deviation)
Unit of measure:  Emergency care in the last 6 months
Number Analyzed 56 participants 56 participants 112 participants
0.45  (0.81) 0.59  (1.30) 0.52  (1.08)
[1]
Measure Description: Number of emergency care in the last 6 months
1.Primary Outcome
Title Asthma Control Measured With Asthma Control Test (ACT)
Hide Description Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description:

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.49  (4.13) 18.23  (5.70)
2.Secondary Outcome
Title Number of Asthma Exacerbations
Hide Description Number of asthma exacerbations during the study period
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description:

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: Asthma exacerbations
1  (0.20) 0  (0.4)
3.Secondary Outcome
Title Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)
Hide Description

Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids:

Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: > 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description:

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Overall Number of Participants Analyzed 53 53
Measure Type: Count of Participants
Unit of Measure: Participants
Low
18
  34.0%
24
  45.3%
Half
30
  56.6%
23
  43.4%
High
5
   9.4%
6
  11.3%
4.Secondary Outcome
Title Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)
Hide Description Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description:

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.34  (1.29) 4.64  (1.56)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group (IG) Control Group (CG)
Hide Arm/Group Description

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol

Placebo in a presentation with an identical appearance taken weekly by the oral route

Placebo

All-Cause Mortality
Intervention Group (IG) Control Group (CG)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)      0/56 (0.00%)    
Hide Serious Adverse Events
Intervention Group (IG) Control Group (CG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/56 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group (IG) Control Group (CG)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/56 (5.36%)      2/56 (3.57%)    
Gastrointestinal disorders     
dyspepsia *  3/56 (5.36%)  3 2/56 (3.57%)  2
*
Indicates events were collected by non-systematic assessment
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: Dr. Rubén Andújar-Espinosa
Organization: MurciaSalud
Phone: 0034669500052
EMail: rubemed@hotmail.com
Layout table for additonal information
Responsible Party: Rubén Andújar, MurciaSalud
ClinicalTrials.gov Identifier: NCT02805907    
Other Study ID Numbers: 300681
First Submitted: June 13, 2016
First Posted: June 20, 2016
Results First Submitted: February 14, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017