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

This study has been terminated.
(Lack of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152841
First Posted: September 9, 2005
Last Update Posted: March 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
University Health Network, Toronto
  Purpose

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

Condition Intervention Phase
Crohn's Disease Ulcerative Colitis Mild or Moderate Anaemia Drug: Iron supplement 300-600 mg/day Drug: Vitamin E 800IU Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • calprotectin in stools at baseline, week 4, week 6, week 10

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

Estimated Enrollment: 30
Study Start Date: June 2002
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152841


Locations
Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Allard Johane, MD, FRCPC University Health Network - Toronto General Hospital
  More Information

Responsible Party: Dr. Johane Allard, Toronto General Hospital- UHN
ClinicalTrials.gov Identifier: NCT00152841     History of Changes
Other Study ID Numbers: 02-0289-E
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: March 17, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Iron
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents