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:
Collaborator:
Dentsply Implants
Information provided by:
Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00869427
First received: March 25, 2009
Last updated: July 2, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Silent bacteriuria [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869427

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

No publications provided

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)
Study First Received: March 25, 2009
Last Updated: July 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Data Protection Authority

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

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

ClinicalTrials.gov processed this record on September 16, 2014