- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422901
A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bianka B Krick, CRA
- Phone Number: 0049-641-7960963
- Email: bianka.krick@pascoe.de
Study Contact Backup
- Name: Jennifer Lebert, CRA
- Phone Number: 0049-641-7960955
- Email: jennifer.lebert@pascoe.de
Study Locations
-
-
Hessen
-
Giessen, Hessen, Germany, 35394
- Recruiting
- multiple medical German Practices of physicians and medical practitioners
-
Contact:
- multiple medical practices
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
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:
|
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:
|
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:
|
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:
|
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
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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)
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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
Investigators
- Study Director: Holger Michels, MD & M. Sci., Pascoe Pharmazeutische Praeparate GmbH
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Disease Attributes
- Hematologic Diseases
- Nutrition Disorders
- Hemorrhagic Disorders
- Hemostatic Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Chronic Disease
- Acute Disease
- Scurvy
- Ascorbic Acid Deficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
Other Study ID Numbers
- 183A12VC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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