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Trial record 1 of 8 for:    vitamin C and AND "Urinary tract infections"
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Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

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. Identifier: NCT00869427
Recruitment Status : Terminated (Inability to recruit sufficient number of patients)
First Posted : March 26, 2009
Last Update Posted : July 5, 2010
Dentsply Sirona Implants
Information provided by:
Sunnaas Rehabilitation Hospital

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%.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Spinal Cord Injury Drug: vitamin C Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : March 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Arm Intervention/treatment
Active Comparator: 1 vitamin C
Vitamin C 1g bid
Drug: vitamin C
vitamin C 1g bid for 1 year

No Intervention: 2
Usual Care

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00869427

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

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Responsible Party: Sunnaas Rehabilitation Hospital, Nils Hjeltnes Identifier: NCT00869427    
Other Study ID Numbers: 545-07286a 1.2007.2483 (REK)
2007-005657-29 (EudraCT)
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: January 2010
Keywords provided by Sunnaas Rehabilitation Hospital:
Spinal cord injury
Vitamin C
Additional relevant MeSH terms:
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Urinary Tract Infections
Ascorbic Acid
Communicable Diseases
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urologic Diseases
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents