A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Vit C deficiency in acute diseases Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g |
Drug: vitamin C
According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
Other Names:
|
| Vit C deficiency in chronic diseases Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g |
Drug: vitamin C
According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- change in general and disease-specific symptoms [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
Secondary Outcome Measures
- 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 efficacy is measured by a score: Very good efficacy (complete regression of symptoms) Good efficacy (symptoms was much improved) Moderate efficacy (symptoms was slightly improved) No efficacy (symptoms remained unchanged) No efficacy (symptoms worsened)
- 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)]
Global assessment of tolerability is measured by a score: Very good tolerability (no side effects) Poor tolerability (side effects occurred)
- 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)]
number of adverse reactions due to PASCORBIN® 7.5 g
- epidemiology of the underlying diseases [on visit 1 (begin of the study) week 1]
number of patients with different underlying diseases due to vitamin C deficiency
- therapy duration [time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)]
measured in weeks or months
- dosage scheme [therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)]
number of infusions within the therapy duration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients with vitamin C deficiency
-
patients >= 12 years old
Exclusion Criteria:
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an oxalate urolithiasis,
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iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have received recently transfused packed red blood cells
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under 12 years of age or
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are pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | multiple medical German Practices of physicians and medical practitioners | Giessen | Hessen | Germany | 35394 |
Sponsors and Collaborators
- Pascoe Pharmazeutische Praeparate GmbH
Investigators
- Study Director: Holger Michels, MD & M. Sci., Pascoe Pharmazeutische Praeparate GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 183A12VC