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

NCT ID: NCT06983847

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-12
• Study Completion Date: 2028-11-14

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.

Conditions

Deficiency, Vitamin C; Chronic Disease; Acute Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Michels, Study Director

Role: STUDY_DIRECTOR

Pascoe Pharmazeutische Praeparate GmbH

Locations

Multiple Physicians from Austria

Vienna, Etc., Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Jennifer Brueckmann, CRA

Role: CONTACT

jennifer.brueckmann@pascoe.de

00496417960955

Bianka B. Krick, CRA

Role: CONTACT

bianka.krick@pascoe.de

00494617960963

Other Identifiers

214A18VCAT

Identifier Type: -

Identifier Source: org_study_id