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

• ClinicalTrials.gov Identifier: NCT00921934
• Recruitment Status: Completed
• First Posted: June 17, 2009
• Results First Posted: October 26, 2012
• Last Update Posted: December 21, 2017
• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Collaborator: Dr. Loges & Co. GmbH
• Information provided by (Responsible Party): Pascoe Pharmazeutische Praeparate GmbH

Tracking Information

• First Submitted Date: June 16, 2009
• First Posted Date: June 17, 2009
• Results First Submitted Date: August 1, 2012
• Results First Posted Date: October 26, 2012
• Last Update Posted Date: December 21, 2017
• Study Start Date: April 2009
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2012)

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

VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles
• Official Title: PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study

Brief Summary

Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases.

Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.

Condition

• Virus Diseases
• Herpes Zoster

• Intervention: Not Provided

Study Groups/Cohorts

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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2012): 68
• Original Estimated Enrollment (submitted: June 16, 2009): 350
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

• adult patients
• acute viral infection (especially herpes zoster)
• Primary Care patient
• eligible for add-on therapy with vitamin C
• willingness to provide pseudonymized data to the Sponsor

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00921934
• Other Study ID Numbers: 168 A 08 VC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
• Study Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Collaborators: Dr. Loges & Co. GmbH

Investigators

• Principal Investigator: Martin Schencking, MD; Rheinstr. 77a, D-56235 Ransbach-Baumbach
• Study Director: Bianka Krick; Pascoe Pharmazeutische Praeparate GmbH

• PRS Account: Pascoe Pharmazeutische Praeparate GmbH
• Verification Date: November 2017