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

NCT ID: NCT00869427

Last Updated: 2010-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Urinary Tract Infection; Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1 vitamin C

Vitamin C 1g bid

Group Type: ACTIVE_COMPARATOR

vitamin C

Intervention Type: DRUG

vitamin C 1g bid for 1 year

2

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

vitamin C

vitamin C 1g bid for 1 year

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nils Hjeltnes

Principal Investigators

Nils Hjeltnes, MD, PhD

Role: STUDY_DIRECTOR

Sunnaas Rehabilitation Hospital

Other Identifiers

2007-005657-29 (EudraCT)

Identifier Type: -

Identifier Source: secondary_id

545-07286a 1.2007.2483 (REK)

Identifier Type: -

Identifier Source: org_study_id