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

Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)

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

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease; Ulcerative Colitis; Mild or Moderate Anaemia
• Intervention / Treatment: Drug: Iron supplement 300-600 mg/day; Drug: Vitamin E 800IU

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
calprotectin in stools at baseline, week 4, week 6, week 10

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Allard Johane, MD, FRCPC, University Health Network - Toronto General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 9, 2005

Study Record Updates

• Last Update Posted (Estimate): March 17, 2009
• Last Update Submitted That Met QC Criteria: March 16, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: 02-0289-E