Crohn's Disease, Mild or Moderate Anaemia, Ulcerative Colitis
Conditions
Brief 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
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
Interventions
DRUGIron supplement 300-600 mg/day
DRUGVitamin E 800IU
Sponsors
Crohn's and Colitis Foundation
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| calprotectin in stools at baseline, week 4, week 6, week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| disease activity index | — |
| oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase) | — |
| blood measurement of CBD | — |
| iron status | — |
Countries
Canada
Outcome results
None listed