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

Phase 2

Terminated

• Conditions: Crohn's Disease; Ulcerative Colitis; Mild or Moderate Anaemia

• Registration Number: NCT00152841
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-16
• Last Update Posted: 2009-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
calprotectin in stools at baseline, week 4, week 6, week 10

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada