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

MurciaSalud

Status and phase: Completed; Phase 4

Conditions: Asthma, Bronchial

Treatments: Drug: Calcifediol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02805907

300681

Details and patient eligibility

About

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).

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

Intervention Group (IG)

Experimental group

Description:

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

Treatment:

Drug: Calcifediol

Control Group (CG)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo