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

Overview

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%.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2011

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.

Interventions

  • Drug: vitamin C
    • vitamin C 1g bid for 1 year

Arms, Groups and Cohorts

  • Active Comparator: 1 vitamin C
    • Vitamin C 1g bid
  • No Intervention: 2
    • Usual Care

Clinical Trial Outcome Measures

Primary Measures

  • Clinical episodes of UVI treated by antibiotics
    • Time Frame: one year

Secondary Measures

  • Silent bacteriuria
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnaas Rehabilitation Hospital
  • Collaborator
    • Dentsply Sirona Implants and Consumables
  • Provider of Information About this Clinical Study
    • Sunnaas Rehabilitation Hospital, Nils Hjeltnes
  • Overall Official(s)
    • Nils Hjeltnes, MD, PhD, Study Director, Sunnaas Rehabilitation Hospital

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