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A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency

Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06983847
Enrollment
1000
Registered
2025-05-21
Start date
2019-01-12
Completion date
2028-11-14
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Disease, Chronic Disease, Deficiency, Vitamin C

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.

Interventions

None listed

Sponsors

Pascoe Pharmazeutische Praeparate GmbH
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change in general and disease-specific symptomstherapy 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

MeasureTime frameDescription
Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5gtherapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)Global assessment of efficacy is measured by a score: * Very good efficacy (complete regression of symptoms) * Good efficacy (symptoms was much improved) * Moderate efficacy (symptoms was slightly improved) * No efficacy (symptoms remained unchanged) * No efficacy (symptoms worsened)
Dosage schemeNumber of infusions through study completion, up to appr. 12 weeksNumber of infusions during the observational time
Global Assessment of Tolerabilityon last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)Global Assessment of Tolerability of the treatment with Vitamin C-Injektopas® 7,5g Global assessment of tolerability is measured by a score: * Very good tolerability (no side effects) * Poor tolerability (side effects occurred)
Quality of life in chronic disease (Numeric Scale)therapy duration, an expected average of 12 weeks (for chronic diseases)Quality of life in chronic disease, Numeric Scale (NRS) from 0 - 10

Countries

Austria

Contacts

CONTACTJennifer Brueckmann, CRA
jennifer.brueckmann@pascoe.de00496417960955
CONTACTBianka B. Krick, CRA
bianka.krick@pascoe.de00494617960963
STUDY_DIRECTORHolger Michels, Study Director

Pascoe Pharmazeutische Praeparate GmbH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026