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

NCT ID: NCT02422901

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Vitamin C Deficiency Acute Disease Chronic Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Vit C deficiency in acute diseases

Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g

vitamin C

Intervention Type DRUG

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.

Vit C deficiency in chronic diseases

Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g

vitamin C

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Pascorbin® 7.5g

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger Michels, MD & M. Sci.

Role: STUDY_DIRECTOR

Pascoe Pharmazeutische Praeparate GmbH

Locations

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multiple medical German Practices of physicians and medical practitioners

Giessen, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bianka B Krick, CRA

Role: CONTACT

0049-641-7960963

Jennifer Lebert, CRA

Role: CONTACT

0049-641-7960955

Facility Contacts

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multiple medical practices

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29950123 (View on PubMed)

Other Identifiers

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183A12VC

Identifier Type: -

Identifier Source: org_study_id

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