Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis
NCT ID: NCT00152841
Last Updated: 2009-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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1. iron supplementation will increase disease activity and oxidative stress
2. the addition of antioxidant vitamin will reduce this detrimental effect
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Detailed Description
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1. If mild anaemia, patients are randomized to 300 mg of ferrous fumarate or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks.
2. If moderate anaemia, patients will receive 600 mg of ferrous fumarate for 10 weeks. They are randomized to either vitamin E (800 IU) or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Interventions
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Iron supplement 300-600 mg/day
Vitamin E 800IU
Eligibility Criteria
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Inclusion Criteria
* diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease)
* with mild or moderate anaemia
Exclusion Criteria
* not diagnosed with short bowel syndrome
* not taking iron supplement or antioxidant vitamins and minerals
18 Years
ALL
No
Sponsors
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Crohn's and Colitis Foundation
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Toronto General Hospital- UHN
Principal Investigators
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Allard Johane, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University Health Network - Toronto General Hospital
Locations
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University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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02-0289-E
Identifier Type: -
Identifier Source: org_study_id
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