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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00152841
• Other study ID #: 02-0289-E
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: March 16, 2009
• Start date: June 2002

Study information

• Verified date: March 2009
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Mild or Moderate Anaemia
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Iron supplement 300-600 mg/day

• Vitamin E 800IU

Locations

Country	Name	City	State
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Crohn's and Colitis Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calprotectin in stools at baseline, week 4, week 6, week 10
Secondary	disease activity index
Secondary	oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
Secondary	blood measurement of CBD
Secondary	iron status