A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- change in general and disease-specific symptoms
研究概览
简要总结
The aim of this long-term observational study is the documentation of the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the investigators focus on the acquisition of data of the underlying diseases and the reduction of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this, exact assessment of medical tolerance and details of treatment requirements are further aims. Here the investigators take into account acute and chronic underlying medical conditions. Further health economic data are collected.
详细描述
The observational study began on 01 November 2012 and is scheduled for a period of 10 years continued (until 01 November 2022). The duration of the observational study for each patient is not fixed corresponding to the character of a non-interventional study. According to the underlying disease, characterized either acute or chronic, there are 2 and 3 observations within the treatment period, respectively. Documentation comprises the course of the underlying diseases (by tracking of general and diseases-specific symptoms), drug compatibility (by ADR assessment), concomitant medication or other treatment, health economic data, details of treatment regimen and standard epidemiological data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with vitamin C deficiency
- •patients >= 12 years old
排除标准
- •an oxalate urolithiasis,
- •iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have received recently transfused packed red blood cells
- •under 12 years of age or
- •are pregnant or breastfeeding.
研究组 & 干预措施
Vit C deficiency in acute diseases
Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g
干预措施: vitamin C (Drug)
Vit C deficiency in chronic diseases
Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g
干预措施: vitamin C (Drug)
结局指标
主要结局
change in general and disease-specific symptoms
时间窗: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
The main aim was to measure the success of the treatment with Pascorbin® 7.5 g by the documentation of the change in general and disease-specific symptoms. The symptoms are measured by a score: 0 = not present, 1 = slightly, 2 = moderate and 3 = strong The change of the symptoms is measured in change groups: * number of patients with improved symptoms * number of patients with unchanged symptoms * number of patients with worsened symptoms
次要结局
- global assessment of efficacy of treatment with PASCORBIN® 7.5 g(therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))
- Global assessment of tolerability of treatment with PASCORBIN® 7.5 g(on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))
- number of adverse reactions due to PASCORBIN® 7.5 g(on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))
- epidemiology of the underlying diseases(on visit 1 (begin of the study) week 1)
- therapy duration(time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))
- dosage scheme(therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))