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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.
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.
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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 Pascorbin® 7.5 g |
| |
| Vit C deficiency in chronic diseases | Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin C | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change in general and disease-specific symptoms | 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:
| 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 PASCORBIN® 7.5 g | 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 | |
|---|---|---|---|---|
| Bianka B Krick, CRA | Contact | 0049-641-7960963 | bianka.krick@pascoe.de | |
| Jennifer Lebert, CRA | Contact | 0049-641-7960955 | jennifer.lebert@pascoe.de |
| Name | Affiliation | Role |
|---|---|---|
| Holger Michels, MD & M. Sci. | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| multiple medical German Practices of physicians and medical practitioners | Recruiting | Giessen | Hesse | 35394 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29950123 | Derived | Vollbracht C, Raithel M, Krick B, Kraft K, Hagel AF. Intravenous vitamin C in the treatment of allergies: an interim subgroup analysis of a long-term observational study. J Int Med Res. 2018 Sep;46(9):3640-3655. doi: 10.1177/0300060518777044. Epub 2018 Jun 27. |
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All data are anonymous. Patient data list only will be sent to regulatory authorities.
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| ID | Term |
|---|---|
| D001206 | Ascorbic Acid Deficiency |
| D000208 | Acute Disease |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Global assessment of tolerability of treatment with PASCORBIN® 7.5 g | 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) |
| number of adverse reactions due to PASCORBIN® 7.5 g | 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 | number of patients with different underlying diseases due to vitamin C deficiency | on visit 1 (begin of the study) week 1 |
| therapy duration | measured in weeks or months | time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) |
| dosage scheme | number of infusions within the therapy duration | therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |