NCT00152841

Brief Summary

Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia:

  1. 1.iron supplementation will increase disease activity and oxidative stress
  2. 2.the addition of antioxidant vitamin will reduce this detrimental effect

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

March 17, 2009

Status Verified

March 1, 2009

Enrollment Period

6.7 years

First QC Date

September 7, 2005

Last Update Submit

March 16, 2009

Conditions

Crohn's DiseaseUlcerative ColitisMild or Moderate Anaemia

Outcome Measures

Primary Outcomes (1)

  • calprotectin in stools at baseline, week 4, week 6, week 10

Secondary Outcomes (4)

  • disease activity index

  • oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)

  • blood measurement of CBD

  • iron status

Interventions

Iron supplement 300-600 mg/dayDRUG
Vitamin E 800IUDRUG

Eligibility Criteria

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

You may qualify if:

  • \> 18 years old
  • diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease)
  • with mild or moderate anaemia

You may not qualify if:

  • not diagnosed with bowel obstruction
  • not diagnosed with short bowel syndrome
  • not taking iron supplement or antioxidant vitamins and minerals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeLymphoma, Follicular

Interventions

Iron-Dextran ComplexVitamin E

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydratesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Allard Johane, MD, FRCPC

    University Health Network - Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

June 1, 2002

Primary Completion

February 1, 2009

Last Updated

March 17, 2009

Record last verified: 2009-03

Locations

CA(1)