Vitamin C DeficiencyNCT02422901
A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
An observational study of Vitamin C Deficiency and Acute Disease, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vitamin C Deficiency, Acute Disease, Chronic Disease
- What is being tested?
- vitamin C
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Who may be able to join
- patients with vitamin C deficiency
- patients >= 12 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
multiple medical German Practices of physicians and medical practitioners
Giessen, Hesse, 35394
multiple medical practices
About this study
Official title: A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
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.
Read the 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.
- Conditions
- Vitamin C Deficiency, Acute Disease, Chronic Disease
- Being tested
- vitamin C
- Medical subject headings
- Ascorbic Acid Deficiency, Acute Disease, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
Also called Pascorbin® 7.5g
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.
| Study group | Role | What they receive |
|---|---|---|
| Vit C deficiency in acute diseases | Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g Receives: 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 Receives: Drug: vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Global assessment of efficacy is measured by a score:
- Very good efficacy (complete regression of symptoms)
- Good efficacy (symptoms was much improved)
- Moderate efficacy (symptoms was slightly improved)
- No efficacy (symptoms remained unchanged)
- No efficacy (symptoms worsened)
Measured: 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
Global assessment of tolerability is measured by a score:
- Very good tolerability (no side effects)
- Poor tolerability (side effects occurred)
Measured: 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
number of adverse reactions due to PASCORBIN® 7.5 g
Measured: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
epidemiology of the underlying diseases
number of patients with different underlying diseases due to vitamin C deficiency
Measured: on visit 1 (begin of the study) week 1
therapy duration
measured in weeks or months
Measured: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
dosage scheme
number of infusions within the therapy duration
Measured: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin C DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holger Michels, MD & M. Sci., Study director, Pascoe Pharmazeutische Praeparate GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422901
- Sponsor's protocol ID
- 183A12VC
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2015
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: All data are anonymous. Patient data list only will be sent to regulatory authorities.
Publications
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.
PubMed 29950123
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
- ClinicalTrials.gov ID
- NCT02422901
- Acronym / sponsor ID
- 183A12VC
- Conditions
- Vitamin C Deficiency, Acute Disease, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vit C deficiency in acute diseases | – | Drug: vitamin CPatients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g |
| Vit C deficiency in chronic diseases | – | Drug: vitamin CPatients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Key inclusion criteria (2 listed)
- patients with vitamin C deficiency
- patients >= 12 years old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin CAlso: Pascorbin® 7.5gAccording 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. | Drug | Vit C deficiency in acute diseases, Vit C deficiency in chronic diseases |
Primary outcome
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: * number of patients with improved symptoms * number of patients with unchanged symptoms * number of patients with worsened symptoms
6 secondary outcomes
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 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)
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)
epidemiology of the underlying diseases
Time frame: on visit 1 (begin of the study) week 1
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)
dosage scheme
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 29950123Vollbracht 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.
- Individual participant dataSharing planned: No. All data are anonymous. Patient data list only will be sent to regulatory authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Michels, MD & M. Sci. study director
Pascoe Pharmazeutische Praeparate GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin C Deficiency and Acute Disease, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianka B Krick, CRA (0049-641-7960963, bianka.krick@pascoe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02422901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.