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

April 19, 2022 updated by: Pascoe Pharmazeutische Praeparate GmbH

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

The aim of this long-term observational study is the documentation of the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the investigators focus on the acquisition of data of the underlying diseases and the reduction of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this, exact assessment of medical tolerance and details of treatment requirements are further aims. Here the investigators take into account acute and chronic underlying medical conditions. Further health economic data are collected.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The observational study began on 01 November 2012 and is scheduled for a period of 10 years continued (until 01 November 2022). The duration of the observational study for each patient is not fixed corresponding to the character of a non-interventional study. According to the underlying disease, characterized either acute or chronic, there are 2 and 3 observations within the treatment period, respectively. Documentation comprises the course of the underlying diseases (by tracking of general and diseases-specific symptoms), drug compatibility (by ADR assessment), concomitant medication or other treatment, health economic data, details of treatment regimen and standard epidemiological data.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Hessen
      • Giessen, Hessen, Germany, 35394
        • Recruiting
        • multiple medical German Practices of physicians and medical practitioners
        • Contact:
          • multiple medical practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • patients with vitamin C deficiency
  • patients >= 12 years old

Exclusion Criteria:

  • an oxalate urolithiasis,
  • iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have received recently transfused packed red blood cells
  • under 12 years of age or
  • are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vit C deficiency in acute diseases
Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g
According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
Other Names:
  • Pascorbin® 7.5g
Vit C deficiency in chronic diseases
Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g
According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
Other Names:
  • Pascorbin® 7.5g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Pascorbin® 7.5 g 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
global assessment of efficacy of treatment with PASCORBIN® 7.5 g
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)
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Global assessment of tolerability of treatment with PASCORBIN® 7.5 g
Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)

Global assessment of tolerability is measured by a score:

  • Very good tolerability (no side effects)
  • Poor tolerability (side effects occurred)
on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
number of adverse reactions due to PASCORBIN® 7.5 g
Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
number of adverse reactions due to PASCORBIN® 7.5 g
on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
epidemiology of the underlying diseases
Time Frame: on visit 1 (begin of the study) week 1
number of patients with different underlying diseases due to vitamin C deficiency
on visit 1 (begin of the study) week 1
therapy duration
Time Frame: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measured in weeks or months
time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
dosage scheme
Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
number of infusions within the therapy duration
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Holger Michels, MD & M. Sci., Pascoe Pharmazeutische Praeparate GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All data are anonymous. Patient data list only will be sent to regulatory authorities.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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