Vitamin C Spinal Cord Injury
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%.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Tract Infection Spinal Cord Injury | Drug: vitamin C | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured |
| Study Start Date : | March 2009 |
| Estimated Primary Completion Date : | June 2011 |
| Estimated Study Completion Date : | June 2011 |
Resource links provided by the National Library of Medicine 
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1 vitamin C Vitamin C 1g bid | Drug: vitamin C vitamin C 1g bid for 1 year |
| No Intervention: 2 Usual Care |
Primary Outcome Measures :
- Clinical episodes of UVI treated by antibiotics [ Time Frame: one year ]
Secondary Outcome Measures :
- Silent bacteriuria [ Time Frame: one year ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869427
Sunnaas Rehabilitation Hospital
Dentsply Sirona Implants
| Study Director: | Nils Hjeltnes, MD, PhD | Sunnaas Rehabilitation Hospital |
| Responsible Party: | Sunnaas Rehabilitation Hospital, Nils Hjeltnes |
| ClinicalTrials.gov Identifier: | NCT00869427 |
| Other Study ID Numbers: | 545-07286a 1.2007.2483 (REK) 2007-005657-29 (EudraCT) |
| First Posted: | March 26, 2009 Key Record Dates |
| Last Update Posted: | July 5, 2010 |
| Last Verified: | January 2010 |
Keywords provided by Sunnaas Rehabilitation Hospital:
| UVI Spinal cord injury Prevention Vitamin C |
Additional relevant MeSH terms:
| Infections Communicable Diseases Urinary Tract Infections Spinal Cord Injuries Disease Attributes Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System | Wounds and Injuries Urologic Diseases Ascorbic Acid Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Source: https://clinicaltrials.gov/ct2/show/NCT00869427
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