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

NCT06983847 | Recruiting

• 1 other identifier: 214A18VCAT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Deficiency, Vitamin C; Chronic Disease; Acute Disease

Outcome Measures

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

  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

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

• Dosage scheme

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

• Global Assessment of Tolerability

  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)

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with vitamin C deficiency
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

Multiple Physicians from Austria

Vienna, Etc., Austria, Austria

RECRUITING

MeSH Terms

Conditions

Ascorbic Acid Deficiency; Chronic Disease; Acute Disease

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Holger Michels, Study Director

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Central Study Contacts

Jennifer Brueckmann, CRA

CONTACT

00496417960955; jennifer.brueckmann@pascoe.de

Bianka B. Krick, CRA

CONTACT

00494617960963; bianka.krick@pascoe.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: January 12, 2019
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): November 14, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)