Overview

This trial is active, not recruiting.

Condition asthma, bronchial
Treatments calcifediol, placebo
Phase phase 4
Sponsor MurciaSalud
Start date June 2016
End date January 2017
Trial size 100 participants
Trial identifier NCT02805907, 300681

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
calcifediol
(Placebo Comparator)
Placebo in a presentation with an identical appearance taken weekly by the oral route
placebo

Primary Outcomes

Measure
Asthma Control measured with Asthma Control Test (ACT)
time frame: 6 months

Secondary Outcomes

Measure
Number of Asthma exacerbations
time frame: 6 months
Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0)
time frame: 6 months
Quality of life measured with Mini-AQLQ (Asthma Quality of Life Questionnaire)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Principal investigator Rubén Andújar Espinosa, Medicine
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by MurciaSalud.