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
  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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Johane Allard, Toronto General Hospital- UHN
ClinicalTrials.gov Identifier: NCT00152841     History of Changes
Other Study ID Numbers: 02-0289-E
Study First Received: September 7, 2005
Last Updated: March 16, 2009
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 29, 2014