Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
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).