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

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ClinicalTrials.gov Identifier: NCT02422901
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment
Vitamin C Deficiency Acute Disease Chronic Disease Drug: vitamin C

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Study Start Date : November 2012
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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
Drug: vitamin C
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 Name: 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
Drug: vitamin C
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 Name: Pascorbin® 7.5g




Primary Outcome Measures :
  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 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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) ]
  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422901


Contacts
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Contact: Bianka B Krick, CRA 0049-641-7960963 bianka.krick@pascoe.de
Contact: Jennifer Lebert, CRA 0049-641-7960955 jennifer.lebert@pascoe.de

Locations
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Germany
multiple medical German Practices of physicians and medical practitioners Recruiting
Giessen, Hessen, Germany, 35394
Contact: multiple medical practices         
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
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Study Director: Holger Michels, MD & M. Sci. Pascoe Pharmazeutische Praeparate GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT02422901    
Other Study ID Numbers: 183A12VC
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data are anonymous. Patient data list only will be sent to regulatory authorities.
Additional relevant MeSH terms:
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Scurvy
Ascorbic Acid Deficiency
Chronic Disease
Acute Disease
Disease Attributes
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents