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The goal of this observational study is to learn more about the disease and the symptoms where the product will use and in which patient groups. Further on, it is interesting to know clinical pictures, the symptoms improve. Patients with acute or chronical disease with vitamin c deficiency could be involved.
The main questions it aims to answer are:
The aim of this long-term observational study is to document the use of Vitamin C Injektopas® 7.5g in patients with vitamin C deficiency. The deficiency condition can be diagnosed either by laboratory diagnosis or clinically, i.e. symptomatically on the basis of general vitamin C deficiency symptoms (e.g. weakness, fatigue, susceptibility to infections and psychological complaints such as depressive moods) through to more specific deficiency symptoms, which are primarily related to impaired collagen formation and therefore primarily affect connective tissue, blood vessels, cartilage and bones. These include, above all, haemorrhages in the skin, inflamed and bleeding gums - through to tooth loss, joint effusions, pain in the joints, bones and muscles as well as poorly healing wounds, etc.
The survey should be used to assess the disease underlying the vitamin C deficiency (the so-called underlying disease), the reduction in the symptoms of the disease under therapy and also the tolerability. Both acute and chronic underlying diseases should be taken into account.
In addition to the symptom enquiry, the global assessment of the efficacy and tolerability of therapy with Vitamin C Injektopas® 7.5g is evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vit C deficiency in acute diseases | Patients with vitamin C deficiency due to a acute underlying disease treated with Vitamin-C injektopas® 7.5 g | ||
| Vit C deficiency in chronic diseases | Patients with vitamin C deficiency due to a chronic underlying disease treated with Vitamin-C injektopas® 7.5 g |
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| Measure | Description | Time Frame |
|---|---|---|
| change in general and disease-specific symptoms | The main aim was to measure the success of the treatment with Vitamin C-Injektopas® 7,5g 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:
| therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) |
| Measure | Description | Time Frame |
|---|---|---|
| Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5g | Global assessment of efficacy is measured by a score:
| therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a vitamin C deficiency due to acute or chronic underlying diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Brueckmann, CRA | Contact | 00496417960955 | jennifer.brueckmann@pascoe.de | |
| Bianka B. Krick, CRA | Contact | 00494617960963 | bianka.krick@pascoe.de |
| Name | Affiliation | Role |
|---|---|---|
| Holger Michels, Study Director | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Physicians from Austria | Recruiting | Vienna, Etc. | Austria | Austria |
All data are anonymous. Patient data list only will be sent to regulatory authorities.
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| ID | Term |
|---|---|
| D001206 | Ascorbic Acid Deficiency |
| D002908 | Chronic Disease |
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Dosage scheme | Number of infusions during the observational time | Number of infusions through study completion, up to appr. 12 weeks |
| Global Assessment of Tolerability | Global Assessment of Tolerability of the treatment with Vitamin C-Injektopas® 7,5g Global assessment of tolerability is measured by a score:
| on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) |
| Quality of life in chronic disease (Numeric Scale) | Quality of life in chronic disease, Numeric Scale (NRS) from 0 - 10 | therapy duration, an expected average of 12 weeks (for chronic diseases) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |