Clinical trial NCT02805907: Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Official title: Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma, Bronchial
Lead sponsor: MurciaSalud
Sponsor class: OTHER_GOV
First posted: 2016-06-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Asthma Control Measured With Asthma Control Test (ACT)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Asthma Exacerbations
timeFrame: 6 months
measure: Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)
timeFrame: 6 months
measure: Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)
timeFrame: 6 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Servicio Murciano de Salud
Study officials:
affiliation: MurciaSalud
name: Rubén Andújar Espinosa, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
citation: Andujar-Espinosa R, Salinero-Gonzalez L, Illan-Gomez F, Castilla-Martinez M, Hu-Yang C, Ruiz-Lopez FJ. Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial. Thorax. 2021 Feb;76(2):126-133. doi: 10.1136/thoraxjnl-2019-213936. Epub 2020 Nov 5.