Clinical Trial: Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients with Either Crohn''s Disease or Ulcerative Colitis

This study is currently recruiting patients.
Verified by University Health Network, Toronto September 2005

Sponsors and Collaborators: University Health Network, Toronto
Crohn''''s and Colitis Foundation
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152841

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 II

MedlinePlus related topics:  Anemia;   Crohn''''s Disease;   Ulcerative Colitis

Study Type: Interventional
Study Design: Randomized, Open Label, Placebo Control, Crossover Assignment

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

Further Study Details: 
Primary Outcomes: calprotectin in stools at baseline, week 4, week 6, week 10
Secondary Outcomes: disease activity index; oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase); blood measurement of CBD; iron status
Expected Total Enrollment:  30

Study start: June 2002

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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00152841

Ellie Aghdassi, PhD, RD      416-340-4800  Ext. 4113    ellie.aghdassi@uhn.on.ca

Canada, Ontario
      University Health Network - Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Recruiting
Ellie Aghdassi, PhD, RD  416-340-4800  Ext. 4113    ellie.aghdassi@uhn.on.ca 

Study chairs or principal investigators

Allard Johane, MD, FRCPC,  Principal Investigator,  University Health Network - Toronto General Hospital   

More Information

Study ID Numbers:  02-0289-E
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152841
Health Authority: Canada: Ethics Review Committee
ClinicalTrials.gov processed this record on 2005-09-13

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