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| Sponsors and Collaborators: |
Sunnaas Rehabilitation Hospital Astra Tech AB |
|---|---|
| Information provided by: | Sunnaas Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT00869427 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 vitamin C: Active Comparator
Vitamin C 1g bid
|
Drug: vitamin C
vitamin C 1g bid for 1 year
|
|
2: No Intervention
Usual Care
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Jannicke Falch, MD | +47 6696 9000 | jannicke.falch@sunnaas.no |
| Contact: Nils Hjeltnes, MD, PhD | +47 6696 9000 ext 9297 | nils.hjeltnes@sunnaas.no |
| Norway | |
| SunnaasRH | Recruiting |
| Nesoddtangen, Norway, 1450 | |
| Contact: Jannicke Falch, MD +47 6696 9000 jannicke.falch@sunnaas.no | |
| Contact: Nils Hjeltnes, MD, PhD +47 6696 9000 nils.hjeltnes@sunnaas.no | |
| Principal Investigator: Jannicke Falch, MD | |
| Study Director: | Nils Hjeltnes, MD, PhD | Sunnaas Rehabilitation Hospital |
More Information
| Responsible Party: | Nils Hjeltnes ( Sunnaas Rehabilitation Hospital ) |
| Study ID Numbers: | 545-07286a 1.2007.2483 (REK), 2007-005657-29 (EudraCT) |
| Study First Received: | March 25, 2009 |
| Last Updated: | March 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00869427 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Data Inspectorate |
|
UVI Spinal cord injury Prevention Vitamin C |
|
Antioxidants Spinal Cord Diseases Urinary Tract Infections Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trace Elements Trauma, Nervous System |
Naphazoline Spinal Cord Injuries Urologic Diseases Guaifenesin Vitamins Micronutrients Phenylpropanolamine Ascorbic Acid |
|
Communicable Diseases Antioxidants Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Growth Substances Physiological Effects of Drugs Urinary Tract Infections Nervous System Diseases Wounds and Injuries Central Nervous System Diseases |
Disorders of Environmental Origin Trauma, Nervous System Infection Protective Agents Pharmacologic Actions Spinal Cord Injuries Urologic Diseases Vitamins Micronutrients Ascorbic Acid |
