Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Asthma Control Measured With Asthma Control Test (ACT)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of bronchial asthma
- •serum 25(OH)D3 levels < 30 ng/ml.
排除标准
- •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,
- •breast-feeding
研究组 & 干预措施
Intervention Group (IG)
Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
干预措施: Calcifediol (Drug)
Control Group (CG)
Placebo in a presentation with an identical appearance taken weekly by the oral route
干预措施: Placebo (Drug)
结局指标
主要结局
Asthma Control Measured With Asthma Control Test (ACT)
时间窗: 6 months
Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.
次要结局
- Number of Asthma Exacerbations(6 months)
- Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)(6 months)
- Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)(6 months)
研究者
Rubén Andújar
Medical Doctor. Pulmonologist
MurciaSalud