Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- change in general and disease-specific symptoms
Study Overview
Brief Summary
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:
- how do the symptoms of the disease change
- how is the tolerability
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with vitamin C deficiency
- •Age ≥ 18 years
Exclusion Criteria
- •Hypersensitivity to the active ingredient or any of the excipients
- •Oxalate urolithiasis
- •Iron storage disease (thalassemia, hemochromatosis, sideroblastic anemia) or recent red blood cell transfusion
- •Renal insufficiency
- •Glucose-6-phosphate dehydrogenase deficiency/defect
- •Pregnant/breastfeeding women
Arms & Interventions
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
Outcomes
Primary Outcomes
change in general and disease-specific symptoms
Time Frame: 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 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: * number of patients with improved symptoms * number of patients with unchanged symptoms * number of patients with worsened symptoms
Secondary Outcomes
- Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5g(therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases))
- Dosage scheme(Number of infusions through study completion, up to appr. 12 weeks)
- Global Assessment of Tolerability(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)(therapy duration, an expected average of 12 weeks (for chronic diseases))