Prospective controlled trial to evaluate the effect of vitamin D supplementation on asthma control in children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To evaluate the effect of vitamin D supplementation, on FEV1 in asthmatic children with vitamin D deficiency.
研究概览
简要总结
With growing economy, we spend more time indoors exacerbating the problem of vitamin D deficiency. The prevalence of both asthma, the most common chronic illness in children and vitamin D deficiency have dramatically increased in recent years, suggesting they may be linked and a causal relationship. Vitamin D serves many biological actions apart from its bone maintenance effect. Of relevance to asthma, vitamin D has effects on the immune system and on lung development and function . Preliminary epidemiologic studies hint at a possible role of vitamin D in asthma development and in decreasing exacerbations. However, because of potential confounding factors, well-designed clinical trials are needed to establish this causal relationship. There are paucity of prospective studies that have studied the effect of vitamin D supplementation on asthma control, pulmonary function tests and quality of life score. Given the above background, it would be rational to evaluate the effect of vitamin D supplementation in vitamin D deficient asthmatic children.With growing economy, we spend more time indoors exacerbating the problem of vitamin D deficiency. The prevalence of both asthma, the most common chronic illness in children and vitamin D deficiency have dramatically increased in recent years, suggesting they may be linked and a causal relationship. Vitamin D serves many biological actions apart from its bone maintenance effect. Of relevance to asthma, vitamin D has effects on the immune system and on lung development and function . Preliminary epidemiologic studies hint at a possible role of vitamin D in asthma development and in decreasing exacerbations. However, because of potential confounding factors, well-designed clinical trials are needed to establish this causal relationship. There are paucity of prospective studies that have studied the effect of vitamin D supplementation on asthma control, pulmonary function tests and quality of life score. Given the above background, it would be rational to evaluate the effect of vitamin D supplementation in vitamin D deficient asthmatic children.
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
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Age- Criteria: 5-16yrs Intermittent Cough Breathlessness Recurrent Wheezing present Response to bronchodilator present.
排除标准
- •1.interstitial lung disease 2.congenital heart disease
- •tuberculosis / Cystic fibrosis / HIV infection 4.Bronchomalacia / Laryngomalacia 6.Tracheo-esophageal fistula 7.Medications inducing chronic cough (ACEI) 8.Chronic liver / renal disease 9.Residing outside Delhi or unlikely to come for follow up 10.Frank vitamin D deficiency viz.Harrison’s sulcus?
- •11.Patient have any chest wall deformity.
结局指标
主要结局
To evaluate the effect of vitamin D supplementation, on FEV1 in asthmatic children with vitamin D deficiency.
时间窗: To evaluate the effect of vitamin D supplementation, on FEV1 in asthmatic children with vitamin D deficiency. | FEV1 will be monitored at 3months & 6months follow up period.
次要结局
- i)To compare the following parameters (pre and post intervention ) asthmatic children with vitamin D deficiency on :(1.Change in quality of life after vitamin D supplementation.)