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

This study has been terminated.
(Inability to recruit sufficient number of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869427
First Posted: March 26, 2009
Last Update Posted: July 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dentsply Sirona Implants
Information provided by:
Sunnaas Rehabilitation Hospital
  Purpose
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%.

Condition Intervention Phase
Urinary Tract Infection Spinal Cord Injury Drug: vitamin C Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Resource links provided by NLM:


Further study details as provided by Sunnaas Rehabilitation Hospital:

Primary Outcome Measures:
  • Clinical episodes of UVI treated by antibiotics [ Time Frame: one year ]

Secondary Outcome Measures:
  • Silent bacteriuria [ Time Frame: one year ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 vitamin C
Vitamin C 1g bid
Drug: vitamin C
vitamin C 1g bid for 1 year
No Intervention: 2
Usual Care

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869427


Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
Dentsply Sirona Implants
Investigators
Study Director: Nils Hjeltnes, MD, PhD Sunnaas Rehabilitation Hospital
  More Information

Responsible Party: Sunnaas Rehabilitation Hospital, Nils Hjeltnes
ClinicalTrials.gov Identifier: NCT00869427     History of Changes
Other Study ID Numbers: 545-07286a 1.2007.2483 (REK)
2007-005657-29 (EudraCT)
First Submitted: March 25, 2009
First Posted: March 26, 2009
Last Update Posted: July 5, 2010
Last Verified: January 2010

Keywords provided by Sunnaas Rehabilitation Hospital:
UVI
Spinal cord injury
Prevention
Vitamin C

Additional relevant MeSH terms:
Infection
Communicable Diseases
Spinal Cord Injuries
Urinary Tract Infections
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urologic Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents