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

NCT02422901 | Unknown

• 1 other identifier: 183A12VC
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin C Deficiency; Acute Disease; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• change in general and disease-specific symptoms

  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 Outcomes (6)

• global assessment of efficacy of treatment with PASCORBIN® 7.5 g

  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

  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

  on visit 1 (begin of the study) week 1

• therapy duration

  time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)

Study Arms (2)

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

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

Interventions

vitamin C 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.

Also known as: Pascorbin® 7.5g

Vit C deficiency in acute diseases; Vit C deficiency in chronic diseases

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

multiple medical German Practices of physicians and medical practitioners

Giessen, Hesse, 35394, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 29950123 DERIVED

MeSH Terms

Conditions

Ascorbic Acid Deficiency; Acute Disease; Chronic Disease

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Holger Michels, MD & M. Sci.

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Central Study Contacts

Bianka B Krick, CRA

CONTACT

0049-641-7960963; bianka.krick@pascoe.de

Jennifer Lebert, CRA

CONTACT

0049-641-7960955; jennifer.lebert@pascoe.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 22, 2015
• Study Start: November 1, 2012
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)