Crohn's DiseasePhase 2NCT00152841
Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis
A Phase 2 study testing Iron supplement 300-600 mg/day and Vitamin E 800IU in people with Crohn's Disease and Ulcerative Colitis, run by University Health Network, Toronto at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Mild or Moderate Anaemia
- What is being tested?
- Iron supplement 300-600 mg/day and Vitamin E 800IU
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2002to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease)
- with mild or moderate anaemia
Who cannot join
- not diagnosed with bowel obstruction
- not diagnosed with short bowel syndrome
- not taking iron supplement or antioxidant vitamins and minerals
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)
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
Read the detailed description
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
- Being tested
- Iron supplement 300-600 mg/day, Vitamin E 800IU
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplement 300-600 mg/dayDrug
Vitamin E 800IUDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
calprotectin in stools at baseline, week 4, week 6, week 10
Secondary outcomes (4)
disease activity index
oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
blood measurement of CBD
iron status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionFeb 2009
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Investigators
- Allard Johane, MD, FRCPC, Principal investigator, University Health Network - Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152841
- Sponsor's protocol ID
- 02-0289-E
- Status last verified
- Mar 2009
- First submitted
- 7 Sep 2005
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT00152841
- Acronym / sponsor ID
- 02-0289-E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Jun 2002
- Primary completion
- Feb 2009 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease)
- with mild or moderate anaemia
Key exclusion criteria (3 listed)
- not diagnosed with bowel obstruction
- not diagnosed with short bowel syndrome
- not taking iron supplement or antioxidant vitamins and minerals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron supplement 300-600 mg/day | Drug | – |
| Vitamin E 800IU | Drug | – |
Primary outcome
calprotectin in stools at baseline, week 4, week 6, week 10
4 secondary outcomes
disease activity index
oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
blood measurement of CBD
iron status
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allard Johane, MD, FRCPC principal investigator
University Health Network - Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron supplement 300-600 mg/day and Vitamin E 800IU in people with Crohn's Disease and Ulcerative Colitis, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calprotectin in stools at baseline, week 4, week 6, week 10. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2009.