Clinical trial NCT02422901: A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Official title: A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin C Deficiency
Acute Disease
Chronic Disease
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a vitamin C deficiency due to acute or chronic underlying diseases

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.

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.

Eligibility 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.

Primary outcomes:
measure: change in general and disease-specific symptoms
timeFrame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary outcomes:
measure: global assessment of efficacy of treatment with PASCORBIN® 7.5 g
timeFrame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: Global assessment of tolerability of treatment with PASCORBIN® 7.5 g
timeFrame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: number of adverse reactions due to PASCORBIN® 7.5 g
timeFrame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: epidemiology of the underlying diseases
timeFrame: on visit 1 (begin of the study) week 1
measure: therapy duration
timeFrame: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
measure: dosage scheme
timeFrame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: multiple medical German Practices of physicians and medical practitioners
state: Hessen
Study officials:
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Holger Michels, MD & M. Sci.
role: STUDY_DIRECTOR
References:
citation: Vollbracht C, Raithel M, Krick B, Kraft K, Hagel AF. Intravenous vitamin C in the treatment of allergies: an interim subgroup analysis of a long-term observational study. J Int Med Res. 2018 Sep;46(9):3640-3655. doi: 10.1177/0300060518777044. Epub 2018 Jun 27.