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

July 2, 2010 updated by: Sunnaas Rehabilitation Hospital
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Usual Care
Active Comparator: 1 vitamin C
Vitamin C 1g bid
Drug: vitamin C
vitamin C 1g bid for 1 year

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Silent bacteriuria
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnaas Rehabilitation Hospital

Collaborators

Dentsply Sirona Implants

Investigators

  • Study Director: Nils Hjeltnes, MD, PhD, Sunnaas rehabilitation hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 5, 2010

Last Update Submitted That Met QC Criteria

July 2, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 545-07286a 1.2007.2483 (REK)
  • 2007-005657-29 (EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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