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

Phase 4
Terminated
Conditions
Urinary Tract Infection
Spinal Cord Injury
Interventions
Registration Number
NCT00869427
Lead Sponsor
Sunnaas Rehabilitation Hospital
Brief 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%.

Detailed 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 & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
40
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1 vitamin Cvitamin CVitamin C 1g bid
Primary Outcome Measures
NameTimeMethod
Clinical episodes of UVI treated by antibioticsone year
Secondary Outcome Measures
NameTimeMethod
Silent bacteriuriaone year
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