Spinal Cord Injury, Urinary Tract Infection
Conditions
Keywords
UVI, Spinal cord injury, Prevention, Vitamin C
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.
Interventions
DRUGvitamin C
vitamin C 1g bid for 1 year
Sponsors
Dentsply Sirona Implants and Consumables
Sunnaas Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical episodes of UVI treated by antibiotics | one year |
Secondary
| Measure | Time frame |
|---|---|
| Silent bacteriuria | one year |
Outcome results
None listed