Deficiency, Vitamin CNCT06983847
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 of Deficiency, Vitamin C and Chronic Disease, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Deficiency, Vitamin C, Chronic Disease, Acute Disease
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 12 Jan 2019to 14 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Who may be able to join
- Patients with vitamin C deficiency
- Age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Multiple Physicians from Austria
Vienna, Etc., Austria
About this study
Official title: Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
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.
- Conditions
- Deficiency, Vitamin C, Chronic Disease, Acute Disease
- Medical subject headings
- Ascorbic Acid Deficiency, Chronic Disease, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary outcomes (4)
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)
Measured: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Dosage scheme
Number of infusions during the observational time
Measured: Number of infusions through study completion, up to appr. 12 weeks
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)
Measured: 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)
Quality of life in chronic disease, Numeric Scale (NRS) from 0 - 10
Measured: therapy duration, an expected average of 12 weeks (for chronic diseases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 Jan 2019
- Primary completion12 Jan 2028 (estimated)
- Study completion14 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency, Vitamin CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holger Michels, Study Director, Study director, Pascoe Pharmazeutische Praeparate GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983847
- Sponsor's protocol ID
- 214A18VCAT
- Status last verified
- Sep 2026
- First submitted
- 6 May 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data are anonymous. Patient data list only will be sent to regulatory authorities.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases
- ClinicalTrials.gov ID
- NCT06983847
- Acronym / sponsor ID
- 214A18VCAT
- Conditions
- Deficiency, Vitamin C, Chronic Disease, Acute Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 12 Jan 2028 (estimated)
- Study completion
- 14 Nov 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Key inclusion criteria (2 listed)
- Patients with vitamin C deficiency
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. All data are anonymous. Patient data list only will be sent to regulatory authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Michels, Study Director study director
Pascoe Pharmazeutische Praeparate GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency, Vitamin C and Chronic Disease, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Brueckmann, CRA (00496417960955, jennifer.brueckmann@pascoe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.