Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Spinal Cord Injury Clinical Trial

Official title:

Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00869427
• Other study ID #: 545-07286a 1.2007.2483 (REK)
• Secondary ID: 2007-005657-29 (
• Status: Terminated
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: July 2, 2010
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. In the study, patients will be randomised either to receive vitamin C daily, or not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is that vitamin C will not reduce the number of UVI episodes by 30%.

Description:

The study is an investigator-blind randomised parallel study on the efficacy of vitamin C to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. To be included, patients should have had at least 3 previous UVI episodes over the last two years. 40 patients are included. Patients are randomised to receive either 1 g vitamin C b.i.d. over 1 year, or no vitamin C. The main outcome is the number of clinical UVIs that have been treated with antibiotics.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spinal cord injury

• 3 or more episodes of UVI over previous 2 years

Exclusion Criteria:

• pregnancy

• age <18

• continuous use of antibiotics, hippuric acid or crane berry juice

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• vitamin C
vitamin C 1g bid for 1 year

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	Dentsply Implants

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical episodes of UVI treated by antibiotics		one year	No
Secondary	Silent bacteriuria		one year	No