Urinary Tract InfectionPhase 4NCT00869427
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
A Phase 4 study testing vitamin C in people with Urinary Tract Infection and Spinal Cord Injury, run by Sunnaas Rehabilitation Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Spinal Cord Injury
- What is being tested?
- vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spinal cord injury
- 3 or more episodes of UVI over previous 2 years
Who cannot join
- pregnancy
- age <18
- continuous use of antibiotics, hippuric acid or crane berry juice
About this study
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%.
Read the 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
- Being tested
- vitamin C
- Keywords
- UVI, Spinal cord injury, Prevention, Vitamin C
- Medical subject headings
- Urinary Tract Infections, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
vitamin C 1g bid for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 vitamin C | Active comparator | Vitamin C 1g bid Receives: Drug: vitamin C |
| 2 | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical episodes of UVI treated by antibiotics
Measured: one year
Secondary outcomes (1)
Silent bacteriuria
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Inability to recruit sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Investigators
- Nils Hjeltnes, MD, PhD, Study director, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869427
- Sponsor's protocol ID
- 545-07286a 1.2007.2483 (REK)
- Other IDs
- 2007-005657-29 (EudraCT)
- Status last verified
- Jan 2010
- First submitted
- 25 Mar 2009
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
- ClinicalTrials.gov ID
- NCT00869427
- Acronym / sponsor ID
- 545-07286a 1.2007.2483 (REK)
- Conditions
- Urinary Tract Infection, Spinal Cord Injury
- Keywords
- UVI, Spinal cord injury, Prevention, Vitamin C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit sufficient number of patients
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 vitamin C | Active comparator | Drug: vitamin CVitamin C 1g bid |
| 2 | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spinal cord injury
- 3 or more episodes of UVI over previous 2 years
Key exclusion criteria (3 listed)
- pregnancy
- age <18
- continuous use of antibiotics, hippuric acid or crane berry juice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin Cvitamin C 1g bid for 1 year | Drug | 1 vitamin C |
Primary outcome
Clinical episodes of UVI treated by antibiotics
Time frame: one year
1 secondary outcome
Silent bacteriuria
Time frame: one year
Results and safety
The study was stopped early (reason given: Inability to recruit sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Hjeltnes, MD, PhD study director
Sunnaas Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin C in people with Urinary Tract Infection and Spinal Cord Injury, run by Sunnaas Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit sufficient number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical episodes of UVI treated by antibiotics (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.