NCT01212406已完成4 期
A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of BOS (grade 1) at 3 years after transplantation
研究概览
简要总结
Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation
详细描述
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
- 1:1 inclusion ratio (placebo:Vitamin D).
- Randomisation at discharge after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable LTx recipients at discharge after transplantation.
- •Signed informed consent
- •Adult (age at least 18 years old at moment of transplantation)
- •Able to take oral medication
排除标准
- •Prolonged and/or complicated Intensive care unit-course after transplantation.
- •Early (<30 days post-transplant) post-operative death
- •Major suture problems (airway stenosis or stent)
- •Retransplantation (lung)
- •Previous transplantation (solid organ)
- •Multi-organ transplantation (lung+ other solid organ)
研究组 & 干预措施
Placebo
Placebo Comparator
Olive oil
干预措施: Vitamin D (Drug)
Vitamin D
Experimental
Addition of D-cure (100.000U) to standard care
干预措施: Vitamin D (Drug)
结局指标
主要结局
Prevalence of BOS (grade 1) at 3 years after transplantation
时间窗: 3 years after transplantation
her-evaluation of data
Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation
时间窗: 2 years after transplantation
BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value
次要结局
- Bronchoalveolar lavage(during 2 and 3y of follow-up)
- Peripheral blood(During 2 and 3 years of follow-up)
- Rejection rates(During 2 and 3 years of follow-up)
- Reflux(During 2 and 3 years of follow-up)
- Infection rates(During 2 and 3 years of follow-up)
研究者
研究点 (1)
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