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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:
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152841
First received: September 7, 2005
Last updated: March 16, 2009
Last verified: March 2009
History of Changes

September 7, 2005
March 16, 2009
June 2002
February 2009   (final data collection date for primary outcome measure)
calprotectin in stools at baseline, week 4, week 6, week 10
Same as current
Complete list of historical versions of study NCT00152841 on ClinicalTrials.gov Archive Site
  • disease activity index
  • oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
  • blood measurement of CBD
  • iron status
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
  • Crohn's Disease
  • Ulcerative Colitis
  • Mild or Moderate Anaemia
  • Drug: Iron supplement 300-600 mg/day
  • Drug: Vitamin E 800IU
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
Not Provided
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152841
02-0289-E
No
Dr. Johane Allard, Toronto General Hospital- UHN
University Health Network, Toronto
Crohn's and Colitis Foundation
Principal Investigator: Allard Johane, MD, FRCPC University Health Network - Toronto General Hospital
University Health Network, Toronto
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP