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

Primary Purpose

Urinary Tract Infection, Spinal Cord Injury

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vitamin C
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring UVI, Spinal cord injury, Prevention, Vitamin C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    1 vitamin C

    2

    Arm Description

    Vitamin C 1g bid

    Usual Care

    Outcomes

    Primary Outcome Measures

    Clinical episodes of UVI treated by antibiotics

    Secondary Outcome Measures

    Silent bacteriuria

    Full Information

    First Posted
    March 25, 2009
    Last Updated
    July 2, 2010
    Sponsor
    Sunnaas Rehabilitation Hospital
    Collaborators
    Dentsply Sirona Implants and Consumables
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00869427
    Brief Title
    Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
    Official Title
    Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Inability to recruit sufficient number of patients
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    June 2011 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sunnaas Rehabilitation Hospital
    Collaborators
    Dentsply Sirona Implants and Consumables

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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%.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection, Spinal Cord Injury
    Keywords
    UVI, Spinal cord injury, Prevention, Vitamin C

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1 vitamin C
    Arm Type
    Active Comparator
    Arm Description
    Vitamin C 1g bid
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    Usual Care
    Intervention Type
    Drug
    Intervention Name(s)
    vitamin C
    Intervention Description
    vitamin C 1g bid for 1 year
    Primary Outcome Measure Information:
    Title
    Clinical episodes of UVI treated by antibiotics
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Silent bacteriuria
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nils Hjeltnes, MD, PhD
    Organizational Affiliation
    Sunnaas Rehabilitation Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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