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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005657-29 (EudraCT) |
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Inability to recruit sufficient number of patients
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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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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%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 vitamin C | Active Comparator | Vitamin C 1g bid |
|
| 2 | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin C | Drug | vitamin C 1g bid for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical episodes of UVI treated by antibiotics | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Silent bacteriuria | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils Hjeltnes, MD, PhD | Sunnaas Rehabilitation Hospital | Study Director |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |