Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00152841
Status:
TERMINATED
Last Update Posted:
2009-03-17
First Post:
2005-09-07
Brief Title:
Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohns Disease or Ulcerative Colitis
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease IBD
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HypothesisIn patients with ulcerative colitis and Crohns 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
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 siteextent 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None