Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Overview
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%.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Investigator)
- Study Primary Completion Date: June 2011
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
- Drug: vitamin C
- vitamin C 1g bid for 1 year
Arms, Groups and Cohorts
- Active Comparator: 1 vitamin C
- Vitamin C 1g bid
- No Intervention: 2
- Usual Care
Clinical Trial Outcome Measures
Primary Measures
- Clinical episodes of UVI treated by antibiotics
- Time Frame: one year
Secondary Measures
- Silent bacteriuria
- Time Frame: one year
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Sunnaas Rehabilitation Hospital
- Collaborator
- Dentsply Sirona Implants and Consumables
- Provider of Information About this Clinical Study
- Sunnaas Rehabilitation Hospital, Nils Hjeltnes
- Overall Official(s)
- Nils Hjeltnes, MD, PhD, Study Director, Sunnaas Rehabilitation Hospital
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.