Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn’s Disease or Ulcerative Colitis

Overview

Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia: 1. iron supplementation will increase disease activity and oxidative stress 2. the addition of antioxidant vitamin will reduce this detrimental effect

Full Title of Study: “Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Detailed Description

To maintain site/extent of disease and medication consistent among groups, the design is a double blind crossover placebo-controlled trial. 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

Interventions

  • Drug: Iron supplement 300-600 mg/day
  • Drug: Vitamin E 800IU

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • disease activity index
  • oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
  • blood measurement of CBD
  • iron status

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Collaborator
    • Crohn’s and Colitis Foundation
  • Provider of Information About this Clinical Study
    • Dr. Johane Allard, Toronto General Hospital- UHN
  • Overall Official(s)
    • Allard Johane, MD, FRCPC, Principal Investigator, University Health Network – Toronto General Hospital

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