NCT00869427

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%.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 5, 2010

Status Verified

January 1, 2010

Enrollment Period

2.3 years

First QC Date

March 25, 2009

Last Update Submit

July 2, 2010

Conditions

Urinary Tract InfectionSpinal Cord Injury

Keywords

UVISpinal cord injuryPreventionVitamin C

Outcome Measures

Primary Outcomes (1)

  • Clinical episodes of UVI treated by antibiotics

    one year

Secondary Outcomes (1)

  • Silent bacteriuria

    one year

Study Arms (2)

1 vitamin C

ACTIVE COMPARATOR

Vitamin C 1g bid

Drug: vitamin C

2

NO INTERVENTION

Usual Care

Interventions

vitamin CDRUG

vitamin C 1g bid for 1 year

1 vitamin C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spinal cord injury
  • or more episodes of UVI over previous 2 years

You may not qualify if:

  • pregnancy
  • age \<18
  • continuous use of antibiotics, hippuric acid or crane berry juice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract InfectionsSpinal Cord Injuries

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Nils Hjeltnes, MD, PhD

    Sunnaas Rehabilitation Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 5, 2010

Record last verified: 2010-01