A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Deficiency, Vitamin C, Chronic Disease, Acute Disease. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
Overview
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.
Primary outcome measures
- 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)]
Secondary outcome measures (4)
- Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5g [Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)]
- Dosage scheme [Time frame: Number of infusions through study completion, up to appr. 12 weeks]
- Global Assessment of Tolerability [Time frame: 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) [Time frame: therapy duration, an expected average of 12 weeks (for chronic diseases)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Austria · 1 center
- Multiple Physicians from Austria — Vienna, Etc.
Identifiers
NCT: NCT06983847 · 214A18VCAT