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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

ConditionsDeficiency, Vitamin CChronic DiseaseAcute Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorPascoe Pharmazeutische Praeparate GmbH

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with vitamin C deficiency

Age ≥ 18 years

Disqualifiers

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

Trial population

Patients with a vitamin C deficiency due to acute or chronic underlying diseases

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Vit C deficiency in acute diseases
Group B: Vit C deficiency in chronic diseases

Trial outcomes

Primary outcomes

1

change in general and disease-specific symptoms

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

Time frame
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)

Secondary outcomes

1

Global assessment of efficacy of treatment with Vitamin C-Injektopas® 7,5g

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)

Time frame
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
2

Dosage scheme

Number of infusions during the observational time

Time frame
Number of infusions through study completion, up to appr. 12 weeks
3

Global Assessment of Tolerability

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)

Time frame
on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
4

Quality of life in chronic disease (Numeric Scale)

Quality of life in chronic disease, Numeric Scale (NRS) from 0 - 10

Time frame
therapy duration, an expected average of 12 weeks (for chronic diseases)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pascoe Pharmazeutische Praeparate GmbH

Lead sponsor

Source ClinicalTrials.gov
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