The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- reach sufficient vitamin D level
研究概览
简要总结
Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients
详细描述
Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients.
Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages less than 18 years .
- •Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
- •Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
- •Vitamin D deficient or insufficient CF and non CF bronchiectasis patients
排除标准
- •if they had
- •sufficient Vitamin D level .
- •chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
- •reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.
研究组 & 干预措施
vitamin D 3
oral vitamin D3 drops and tablets
干预措施: Cholecalciferol (vitaminD3) (Drug)
结局指标
主要结局
reach sufficient vitamin D level
时间窗: 6 months
vitamin D more than 30 ng/dl
decrease disease severity
时间窗: 6 months
decrease excerbations and increase lung function
次要结局
未报告次要终点
研究者
Heba Omara
Principal investigator
Ain Shams University