Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Sunnaas Rehabilitation Hospital

Status and phase: Terminated; Phase 4

Conditions: Urinary Tract Infection; Spinal Cord Injury

Treatments: Drug: vitamin C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00869427

545-07286a 1.2007.2483 (REK)

2007-005657-29 (EudraCT)

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

1 vitamin C

Active Comparator group

Description:

Vitamin C 1g bid

Treatment:

Drug: vitamin C

2

No Intervention group

Description:

Usual Care