EFFECT OF VITAMIN D ON ASTHMA CONTROL AND QUALITY OF LIFE IN PATIENTS OF MODERATE BRONCHIAL ASTHMA WITH VITAMIN D DEFICIENCY: A PROSPECTIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1)Asthma control test scores (ACT).
研究概览
简要总结
Bronchial asthma is one of the common chronic inflammatory diseasesaffecting around 300 million people worldwide.
Chronic nature of the disease and regular use of medications significantlyhampers the quality of life.
Vitamin D deficiency prevails in epidemic proportions all over theIndian subcontinent, with a prevalence of 70%–100% in the general population.
Prevalence of vitamin D deficiency amongasthmatic patients has been found to be very high at 77.3%. Evidence suggests that vitamin Dplays a vital role in modulating the immune response and hasanti-inflammatory effect.
Hence in the present study, we plan to determine the effect of vitamin Dsupplementation on asthma control in patients with moderate asthma having vitaminD deficiency and its effect on their quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with moderate asthma diagnosed according to latest GINA guidelines [2022] for at least 1 month.
排除标准
- •1.History of any chronic disease other than asthma (like cancer, liver disease, gall bladder disease, diabetes, uncontrolled hypertension and GI disorders affecting vitamin D absorption).
- •2.Respiratory tract infection within past 4 weeks.
- •3.Known allergy to vitamin D or taking vitamin D supplements.
- •4.Hypercalcemia (>11mg/dl) or taking calcium supplements or history of recurrent kidney stones, Hyperparathyroidism (>65pg/ml) and deranged serum electrolytes.
- •5.Use of concomitant medications that alter vitamin D metabolism (e.g phenytoin, corticosteroids) or absorption (e.g cholestyramine) or those that interfere with study endpoints.
- •6.History of cigarette smoking (more than 10 packs a year).
- •7.Deranged LFT (Liver enzymes >3 times upper limit of normal) or KFT (serum creatinine >1.2mg/dl) 8.Pregnant and nursing mothers.
结局指标
主要结局
1)Asthma control test scores (ACT).
时间窗: 0, 6weeks, 12weeks, 18weeks, 20weeks
2)Frequency of asthma exacerbation.
时间窗: 0, 6weeks, 12weeks, 18weeks, 20weeks
次要结局
- 1)Predictive percentage of forced expiratory volume in 1st second (FeV1), FEV1/FVC.(2)Serum eosinophils levels.)