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

University Health Network, Toronto

Status and phase: Terminated; Phase 2

Conditions: Mild or Moderate Anaemia; Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Iron supplement 300-600 mg/day; Drug: Vitamin E 800IU

Study type: Interventional

Funder types: Other

Identifiers

NCT00152841

02-0289-E

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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