Not Signed In -
Iron Dextran |
DexFerrum; InFeD |
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
|
Purpose
Hypothesis:In patients with ulcerative colitis and Crohn''''s disease diagnosed with mild or moderate anaemia:
- iron supplementation will increase disease activity and oxidative stress
- 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
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.
- 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.
- 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:
- > 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
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
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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