Asthma, Bronchial
Conditions
Brief summary
Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with vitamin D deficiency in degree of asthma control. Materials and methods: A prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels \< 30 ng/ml. Patients were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney disease (creat. \> 2 mg/dl), hypercalcaemia (corrected with proteins \> 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The randomisation process assigned patients to one of two groups: a group that received vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. Demographic, clinical, spirometry and laboratory endpoints were collected. The primary endpoint was degree of asthma control as determined by the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).
Interventions
DRUGCalcifediol
DRUGPlacebo
Sponsors
MurciaSalud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical diagnosis of bronchial asthma * serum 25(OH)D3 levels \< 30 ng/ml.
Exclusion criteria
* smoking habit ≥ 10 pack-years, * taking vitamin D supplements, * kidney disease (creat. \> 2 mg/dl), * hypercalcaemia (corrected with proteins \> 10.5 mg/dl), * repeat episodes of renal colic, * any gastrointestinal disease that might interfere with vitamin D absorption, * severe psychosocial problems, * pregnant * breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Measured With Asthma Control Test (ACT) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma Exacerbations | 6 months | Number of asthma exacerbations during the study period |
| Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | 6 months | 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), |
| Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire) | 6 months | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (IG) Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
Calcifediol | 56 |
| Control Group (CG) Placebo in a presentation with an identical appearance taken weekly by the oral route
Placebo | 56 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Intervention Group (IG) | Total | Control Group (CG) |
|---|---|---|---|
| Age, Continuous | 54.57 years STANDARD_DEVIATION 15.83 | 55.59 years STANDARD_DEVIATION 15.39 | 56.61 years STANDARD_DEVIATION 15 |
| Asthma Severity Intermitent | 5 Participants | 17 Participants | 12 Participants |
| Asthma Severity Mild Persistent | 9 Participants | 20 Participants | 11 Participants |
| Asthma Severity Moderate Persistent | 29 Participants | 56 Participants | 27 Participants |
| Asthma Severity Severe Persistent | 13 Participants | 19 Participants | 6 Participants |
| Emergency care | 0.45 Emergency care in the last 6 months STANDARD_DEVIATION 0.81 | 0.52 Emergency care in the last 6 months STANDARD_DEVIATION 1.08 | 0.59 Emergency care in the last 6 months STANDARD_DEVIATION 1.3 |
| Exacerbations | 1.18 Exacerbations in the last 6 months STANDARD_DEVIATION 1.55 | 1.16 Exacerbations in the last 6 months STANDARD_DEVIATION 2.19 | 1.14 Exacerbations in the last 6 months STANDARD_DEVIATION 2.7 |
| Hospitalizations | 0.11 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.31 | 0.12 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.32 | 0.13 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.33 |
| Initial Asthma Control Test (ACT) | 17.71 units on a scale STANDARD_DEVIATION 4.54 | 18.37 units on a scale STANDARD_DEVIATION 4.59 | 19.02 units on a scale STANDARD_DEVIATION 4.59 |
| Initial Asthma Quality of Life Questionnaire | 4.38 units on a scale STANDARD_DEVIATION 1.62 | 4.62 units on a scale STANDARD_DEVIATION 1.91 | 4.85 units on a scale STANDARD_DEVIATION 1.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 112 Participants | 56 Participants |
| Region of Enrollment Spain | 56 participants | 112 participants | 56 participants |
| Sex: Female, Male Female | 40 Participants | 87 Participants | 47 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 3 / 56 | 2 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Asthma Control Measured With Asthma Control Test (ACT)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (IG) | Asthma Control Measured With Asthma Control Test (ACT) | 20.49 units on a scale | Standard Deviation 4.13 |
| Control Group (CG) | Asthma Control Measured With Asthma Control Test (ACT) | 18.23 units on a scale | Standard Deviation 5.7 |
Secondary
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group (IG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | Low | 18 Participants |
| Intervention Group (IG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | Half | 30 Participants |
| Intervention Group (IG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | High | 5 Participants |
| Control Group (CG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | Low | 24 Participants |
| Control Group (CG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | Half | 23 Participants |
| Control Group (CG) | Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) | High | 6 Participants |
Secondary
Number of Asthma Exacerbations
Number of asthma exacerbations during the study period
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (IG) | Number of Asthma Exacerbations | 1 Asthma exacerbations | Standard Deviation 0.2 |
| Control Group (CG) | Number of Asthma Exacerbations | 0 Asthma exacerbations | Standard Deviation 0.4 |
Secondary
Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (IG) | Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire) | 5.34 units on a scale | Standard Deviation 1.29 |
| Control Group (CG) | Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire) | 4.64 units on a scale | Standard Deviation 1.56 |