Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Condition: Asthma, Bronchial
MeSH terms: Asthma; Vitamin D Deficiency
Intervention: Calcifediol; Placebo
Intervention MeSH terms: Calcifediol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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