Clinical trial NCT06983847: A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency
Official title: Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deficiency, Vitamin C
Chronic Disease
Acute Disease
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a vitamin C deficiency due to acute or chronic underlying diseases

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.

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

Primary outcomes:
measure: change in general and disease-specific symptoms
timeFrame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary outcomes:
measure: Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5g
timeFrame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: Dosage scheme
timeFrame: Number of infusions through study completion, up to appr. 12 weeks
measure: Global Assessment of Tolerability
timeFrame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: Quality of life in chronic disease (Numeric Scale)
timeFrame: therapy duration, an expected average of 12 weeks (for chronic diseases)
Other outcomes:
Locations:
city: Vienna, Etc.
country: Austria
facility: Multiple Physicians from Austria
Study officials:
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Holger Michels, Study Director
role: STUDY_DIRECTOR
References: