Trial Outcomes & Findings for Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles (NCT NCT00921934)

NCT ID: NCT00921934

Last Updated: 2017-12-21

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 68 participants
• Primary outcome timeframe: visit 1 - 3
• Results posted on: 2017-12-21

Participant Flow

The patients were recruited from general practioners between April 2009 and December 2010.

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.

Participant milestones

Measure	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.
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vitamin C n=68 Participants 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.
Age, Customized Between 18 and 65 years	43.6 years STANDARD_DEVIATION 14.5 • n=5 Participants
Age, Customized >=65 years	67.7 years STANDARD_DEVIATION 8.2 • n=5 Participants
Age, Categorical <=18 years	NA Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment Germany	68 participants n=5 Participants
Body mass index Female	24.4 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants
Body mass index Male	27.6 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants
Body mass index Total	25.8 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Weihgt, kg Female	65.6 kg STANDARD_DEVIATION 10.6 • n=5 Participants
Weihgt, kg Male	83.3 kg STANDARD_DEVIATION 12.4 • n=5 Participants
Weihgt, kg Total	73.1 kg STANDARD_DEVIATION 14.3 • n=5 Participants
Concomitant immunosuppressive disease yes	11 participants n=5 Participants
Concomitant immunosuppressive disease no	57 participants n=5 Participants
Duration of Herpes Zoster-specific complaints (separated into groups) 0 to 14 days	31 participants n=5 Participants
Duration of Herpes Zoster-specific complaints (separated into groups) 2 to 6 weeks	30 participants n=5 Participants
Duration of Herpes Zoster-specific complaints (separated into groups) > 6 weeks	7 participants n=5 Participants
Number of concomitant medications for the inclusion diagnosis None	24 participants n=5 Participants
Number of concomitant medications for the inclusion diagnosis 1	24 participants n=5 Participants
Number of concomitant medications for the inclusion diagnosis 2	15 participants n=5 Participants
Number of concomitant medications for the inclusion diagnosis 3	2 participants n=5 Participants
Number of concomitant medications for the inclusion diagnosis 4	3 participants n=5 Participants
Common symptoms at baseline gerneral fatigue Not present	13 participants n=5 Participants
Common symptoms at baseline gerneral fatigue Mild	30 participants n=5 Participants
Common symptoms at baseline gerneral fatigue Moderate	20 participants n=5 Participants
Common symptoms at baseline gerneral fatigue Strong	5 participants n=5 Participants
Common symptoms at baseline impaired concentration Not present	24 participants n=5 Participants
Common symptoms at baseline impaired concentration Mild	24 participants n=5 Participants
Common symptoms at baseline impaired concentration Moderate	17 participants n=5 Participants
Common symptoms at baseline impaired concentration Strong	3 participants n=5 Participants

PRIMARY outcome

Timeframe: visit 1 - 3

Population: Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).

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

Outcome measures

Measure	Vitamin C n=68 Participants 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.
Change of Pain Measured by VAS V3 (week 12)	0.6 pain intensity Standard Deviation 1.1
Change of Pain Measured by VAS V1 (Baseline)	5.8 pain intensity Standard Deviation 2.4
Change of Pain Measured by VAS V2 (week 2)	2.2 pain intensity Standard Deviation 2.2
Change of Pain Measured by VAS Last visit	1.2 pain intensity Standard Deviation 2.0

Adverse Events

Vitamin C

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin C n=68 participants at risk 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.
Nervous system disorders Sensation of heat on the injection site	1.5% 1/68 • Number of events 1 • 1.5 years
Nervous system disorders numbness sensation up to the fingertips	1.5% 1/68 • Number of events 1 • 1.5 years
Nervous system disorders burning	1.5% 1/68 • Number of events 1 • 1.5 years
Skin and subcutaneous tissue disorders Urticarial drug inducted exanthema on truncus	1.5% 1/68 • Number of events 1 • 1.5 years
Skin and subcutaneous tissue disorders Urticarial drug inducted exanthema on torso	1.5% 1/68 • Number of events 1 • 1.5 years
Gastrointestinal disorders protracted diarrhoe	1.5% 1/68 • Number of events 1 • 1.5 years

Additional Information

Dr. med. Martin Schencking

Department for Complementary and Alternative Medicine

Phone: +0049-2602-684-614

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place