CClinicalTrials.gg
RecruitingNCT06983847Updated Sep 17, 2026

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

An observational study in Deficiency, Vitamin C, Chronic Disease and Acute Disease, sponsored by Pascoe Pharmazeutische Praeparate GmbH. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 120 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Deficiency, Vitamin C
  • Chronic Disease
  • Acute Disease
03

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients with vitamin C deficiency
  • Age ≥ 18 years

Exclusion criteria

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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

05

What researchers measure

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)

06

Study locations

1 of 1 sites recruiting
  • Multiple Physicians from Austria
    Vienna, Etc., Austria, Austria
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — All data are anonymous. Patient data list only will be sent to regulatory authorities.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06983847
Lead sponsor
Pascoe Pharmazeutische Praeparate GmbH
Responsible party
Sponsor
First posted
May 21, 2025
Start date
Jan 12, 2019
Primary completion
Jan 12, 2028 (estimated)
Completion
Nov 14, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Jennifer Brueckmann, CRA
Contact
jennifer.brueckmann@pascoe.de
00496417960955
Bianka B. Krick, CRA
Contact
bianka.krick@pascoe.de
00494617960963
Holger Michels, Study Director
study director · Pascoe Pharmazeutische Praeparate GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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