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

Pascoe Natural Healthcare

Status: Unknown

Conditions: Chronic Disease; Acute Disease; Vitamin C Deficiency

Treatments: Drug: vitamin C

Study type: Observational

Funder types: Industry

Identifiers

NCT02422901

183A12VC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 2 patient groups

Vit C deficiency in acute diseases

Description:

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

Treatment:

Drug: vitamin C

Vit C deficiency in chronic diseases

Description:

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

Treatment:

Drug: vitamin C