Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Primary Purpose
Urinary Tract Infection, Spinal Cord Injury
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vitamin C
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring UVI, Spinal cord injury, Prevention, Vitamin C
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1 vitamin C
2
Arm Description
Vitamin C 1g bid
Usual Care
Outcomes
Primary Outcome Measures
Clinical episodes of UVI treated by antibiotics
Secondary Outcome Measures
Silent bacteriuria
Full Information
NCT ID
NCT00869427
First Posted
March 25, 2009
Last Updated
July 2, 2010
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT00869427
Brief Title
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Official Title
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit sufficient number of patients
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Spinal Cord Injury
Keywords
UVI, Spinal cord injury, Prevention, Vitamin C
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 vitamin C
Arm Type
Active Comparator
Arm Description
Vitamin C 1g bid
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Drug
Intervention Name(s)
vitamin C
Intervention Description
vitamin C 1g bid for 1 year
Primary Outcome Measure Information:
Title
Clinical episodes of UVI treated by antibiotics
Time Frame
one year
Secondary Outcome Measure Information:
Title
Silent bacteriuria
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Hjeltnes, MD, PhD
Organizational Affiliation
Sunnaas Rehabilitation Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
We'll reach out to this number within 24 hrs