Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
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Purpose
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%.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Tract Infection Spinal Cord Injury |
Drug: vitamin C |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured |
- Clinical episodes of UVI treated by antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]
- Silent bacteriuria [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 vitamin C
Vitamin C 1g bid
|
Drug: vitamin C
vitamin C 1g bid for 1 year
|
|
No Intervention: 2
Usual Care
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sunnaas Rehabilitation Hospital, Nils Hjeltnes |
| ClinicalTrials.gov Identifier: | NCT00869427 History of Changes |
| Other Study ID Numbers: | 545-07286a 1.2007.2483 (REK), 2007-005657-29 (EudraCT) |
| Study First Received: | March 25, 2009 |
| Last Updated: | July 2, 2010 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Medicines Agency Norway: Data Protection Authority |
Keywords provided by Sunnaas Rehabilitation Hospital:
|
UVI Spinal cord injury Prevention Vitamin C |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Urinary Tract Infections Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Infection Urologic Diseases |
Ascorbic Acid Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013