Official Title

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

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    calcifediol ...
  • Study Participants

    112
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).
Study Started
Jun 30
2016
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Results Posted
Jun 16
2017
Last Update
Jun 16
2017

Drug Calcifediol

Drug Placebo

Intervention Group (IG) Experimental

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

Control Group (CG) Placebo Comparator

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

Criteria

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

Summary

Intervention Group (IG)

Control Group (CG)

All Events

Event Type Organ System Event Term Intervention Group (IG) Control Group (CG)

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.

Intervention Group (IG)

20.49
units on a scale (Mean)
Standard Deviation: 4.13

Control Group (CG)

18.23
units on a scale (Mean)
Standard Deviation: 5.70

Number of Asthma Exacerbations

Number of asthma exacerbations during the study period

Intervention Group (IG)

1.0
Asthma exacerbations (Mean)
Standard Deviation: 0.20

Control Group (CG)

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),

Intervention Group (IG)

Control Group (CG)

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.

Intervention Group (IG)

5.34
units on a scale (Mean)
Standard Deviation: 1.29

Control Group (CG)

4.64
units on a scale (Mean)
Standard Deviation: 1.56

Total

112
Participants

Age, Continuous

55.59
years (Mean)
Standard Deviation: 15.39

Emergency care

0.52
Emergency care in the last 6 months (Mean)
Standard Deviation: 1.08

Exacerbations

1.16
Exacerbations in the last 6 months (Mean)
Standard Deviation: 2.19

Hospitalizations

0.12
Hospitalizations in the last 6 months (Mean)
Standard Deviation: 0.32

Initial Asthma Control Test (ACT)

18.37
units on a scale (Mean)
Standard Deviation: 4.59

Initial Asthma Quality of Life Questionnaire

4.62
units on a scale (Mean)
Standard Deviation: 1.91

Asthma Severity

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Intervention Group (IG)

Control Group (CG)

Drop/Withdrawal Reasons

Intervention Group (IG)

Control Group (CG)