Pulmonology, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
Endocrinology and Nutrition, Hospital General Universitario Reina Sofia, Murcia, Murcia, Spain.
Thorax. 2021 Feb;76(2):126-133. doi: 10.1136/thoraxjnl-2019-213936. Epub 2020 Nov 5.
The relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results.
To evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma.
Randomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma.
One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (-0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).
Among adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety.
NCT02805907.
哮喘与维生素 D 缺乏之间的关系早已为人所知。然而，在这方面进行的干预研究结果却存在矛盾。
评估补充维生素 D 对血清 25-羟维生素 D <30ng/ml 的哮喘患者控制哮喘程度的疗效。
这是一项在成年哮喘患者中进行的随机、三盲、安慰剂对照、平行组研究，患者血清 25-羟维生素 D <30ng/ml。干预组每周接受 16000IU 的 calcifediol 口服补充，对照组在常规哮喘治疗中添加安慰剂。研究时间为 6 个月。主要终点是哮喘控制测试（ACT）确定的哮喘控制程度。次要终点包括使用迷你哮喘生活质量问卷测量的生活质量、哮喘发作次数、口服皮质类固醇周期、吸入皮质类固醇剂量、急诊就诊次数、初级保健医生的非计划性咨询次数和哮喘住院次数。
112 名患者被随机分配（平均年龄 55 岁，87 名[78%]为女性）。112 名患者中，106 名（95%）完成了试验。一半患者（56 名）被分配到干预组，另一半被分配到对照组。与对照组（-0.57）相比，干预组（+3.09）的 ACT 评分显示出统计学上的临床显著改善（差值 3.66（95%CI 0.89 至 5.43）；p<0.001）。在次要终点中，干预组的生活质量显著改善（5.34），而对照组则略有下降（4.64）（差值 0.7（95%CI 0.15 至 1.25）；p=0.01）。
在维生素 D 缺乏的哮喘成人中，与安慰剂相比，每周口服 calcifediol 补充剂可在 6 个月内改善哮喘控制。需要进一步研究来评估长期疗效和安全性。
NCT02805907。
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