Vitamin D Deficiency in Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline
研究概览
简要总结
This study evaluates serum level of Vitamin D in Interstitial Lung Diseases in patients with Interstitial Lung Diseases other than connective tissue diseases associated-Interstitial Lung Diseases and effects of its supplementation.
All patients will receive the standard regimen of treatment (corticosteroids and immunosuppressive drugs)and will be randomly assigned to either Group 1:who will receive Vitamin D supplementation (Interventional group)or Group 2:who will not receive Vitamin D supplementation(Control group).
详细描述
Pulmonary fibrosis was due to chronic inflammation and disordered wound healing in response to damage induced by a variety of agents such as viral infection and radiotherapy or environmental toxins.it is characterized by accumulation of myofibroblasts and excessive deposition of the extracellular matrix.Epithelial cells undergoes epithelial mesenchymal transition (EMT).
Supplementation with vitamin D or its analogs suppresses lung fibrosis via triggering anti-fibrotic effect through attenuation of transforming growth factor beta (TGF-B).vitamin D can reduce TGF-B expression and attenuate TGF-B induced epithelial mesenchymal transition in lung fibroblast and epithelial cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed.
排除标准
- •Patients who have other diseases affecting Vitamin D levels like chronic liver diseases, chronic kidney diseases and malignancy.
- •patients who will be unable to do pulmonary functions or 6-minutes walk test.
- •patients with ischemic heart diseases and congestive heart failure.
- •patients with connective tissue-associated interstitial lung diseases.
- •interstitial lung diseases exacerbation.
研究组 & 干预措施
Interstitial lung patients with low vitamin D
Arm 1:(interventional group): interstitial lung diseases patients with low vitamine D will receive Vitamin D supplementation in form of Vitamin D3 (1.25(OH)2 cholecalciferol) in dose of 200.000 IU intramuscular injection every 2 weeks for 3 months for deficient vitamin D level patients and every month for 3 months for insufficient vitamin D level patients beside ca supplementation in form ca carbonate 600 mg oral capsule once daily for 3 months for all patients in addition to current treatment.
干预措施: Vitamin D3 (1.25 (OH)2 cholecalciferol) (Dietary Supplement)
interstitial lung diseases patients with low vitamin D
Arm 2(control group): interstitial lung diseases patients with vitamin D deficient / insufficient will receive their current treatment only without vitamin D supplementation.
结局指标
主要结局
change in lung functions (spirometric data) from baseline i.e change of Forced vital capacity (FVC) percent predicted values from baseline
时间窗: baseline and 12 week (measurement at enrollment and end of study)
functional improvement via improvement of pulmonary function parameters as regard to volumes like {forced vital capacity(FVC) percent predicted value} .
change in lung functions (spirometric data) from baseline i.e change of Forced expiratory volume in 1st second (FEV1) percent predicted values from baseline
时间窗: baseline and 12 week (measurement at enrollment and end of study)
functional improvement via improvement of pulmonary function parameters as regard to volumes like {forced expiratory volume in 1st second(FEV1) percent predicted value} .
change in lung functions (spirometric data) from baseline i.e change in forced expiratory flow at 25% (FEF25%) percent predicted values from baseline
时间窗: baseline and 12 week (measurement at enrollment and end of study)
functional improvement via improvement of pulmonary function parameters as regard to velocity like {forced expiratory volume in 1st second(FEV1) percent predicted value} .
change in 6-minutes walk distance
时间窗: baseline and 12 week (measurement at enrollment and end of study)
change in 6-minutes walk distance walked by the patient for 6 minutes
次要结局
- change in dyspnea score grading from baseline(baseline and 12 week (measurement at enrollment and end of study))
研究者
Rania Othman Ibrahim
Principle Investigator.
Cairo University