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NCT Number: NCT06983847

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

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Physicians from Austria

Vienna, Etc., Austria

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    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)
  2. Dosage scheme

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

    Number of infusions during the observational time

  3. Global Assessment of Tolerability

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

    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)
  4. Quality of life in chronic disease (Numeric Scale)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bianka B. Krick, CRA

CONTACT

[email protected]

00494617960963

Jennifer Brueckmann, CRA

CONTACT

[email protected]

00496417960955

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Official study title

Observational Study on Vitamin C-Injektopas® 7.5g in Patients With Vitamin C Deficiency Due to Acute and Chronic Diseases

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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