Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles (168)

This study has been completed.
Sponsor:
Collaborator:
Dr. Loges & Co. GmbH
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT00921934
First received: June 16, 2009
Last updated: September 25, 2012
Last verified: August 2012
Results First Received: August 1, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Virus Diseases
Herpes Zoster

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients were recruited from general practioners between April 2009 and December 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Between April 2009 and December 2010 16 general practitioners recorded data of 68 participants with symptomatic herpes zoster (one patient with viral infection) who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment.

Reporting Groups
  Description
Vitamin C Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.

Participant Flow:   Overall Study
    Vitamin C  
STARTED     68  
COMPLETED     68  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vitamin C Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.

Baseline Measures
    Vitamin C  
Number of Participants  
[units: participants]
  68  
Age  
[units: years]
Mean ± Standard Deviation
 
<=18 years     NA  ± NA [1]
Between 18 and 65 years     43.6  ± 14.5  
>=65 years     67.7  ± 8.2  
Age  
[units: participants]
 
<=18 years     NA [2]
Between 18 and 65 years     44  
>=65 years     24  
Gender  
[units: participants]
 
Female     39  
Male     29  
Region of Enrollment  
[units: participants]
 
Germany     68  
Body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
 
Female     24.4  ± 3.9  
Male     27.6  ± 4.9  
Total     25.8  ± 4.6  
Weihgt, kg  
[units: kg]
Mean ± Standard Deviation
 
Female     65.6  ± 10.6  
Male     83.3  ± 12.4  
Total     73.1  ± 14.3  
Concomitant immunosuppressive disease [3]
[units: participants]
 
yes     11  
no     57  
Duration of Herpes Zoster-specific complaints (separated into groups)  
[units: participants]
 
0 to 14 days     31  
2 to 6 weeks     30  
> 6 weeks     7  
Number of concomitant medications for the inclusion diagnosis  
[units: participants]
 
None     24  
1     24  
2     15  
3     2  
4     3  
Common symptoms at baseline gerneral fatigue  
[units: participants]
 
Not present     13  
Mild     30  
Moderate     20  
Strong     5  
Common symptoms at baseline impaired concentration  
[units: participants]
 
Not present     24  
Mild     24  
Moderate     17  
Strong     3  
[1] zero patients in this age group were analyzed
[2] zero patients were analyzed in this age group
[3] Immunosuppressive conditions = malignant neoformation of the mammae, diabetes mellitus, bronchial asthma, neurodermatitis, malignant neoformation, chemotherapy, breast ablation, hyperthyreosis, B-cell lymphoma, laryngeal cancer, pernicious anaemia, hepatitis, non-Hodgkin lymphoma, immunoglobulin-G deficiency, pneumoconiosis.



  Outcome Measures

1.  Primary:   Change of Pain Measured by VAS   [ Time Frame: visit 1 - 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. med. Martin Schencking
Organization: Department for Complementary and Alternative Medicine
phone: +0049-2602-684-614


No publications provided


Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT00921934     History of Changes
Other Study ID Numbers: 168 A 08 VC
Study First Received: June 16, 2009
Results First Received: August 1, 2012
Last Updated: September 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices