Administration of an iron medicine via de blood veins to children with chronic inflammatory bowel disease
- Conditions
- Anemia in children with Inflammatory Bowel Disease (IBD)Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2012-005644-26-NL
- Lead Sponsor
- Atrium Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Children attending a pediatrician/ pediatric gastro- enterologist
2. Suffering from CD/CU (diagnosed according to Porto criteria)
3. Anemia according to WHO criteria
4. Written informed consent of parent with authority.
5. Children aged 0 – 18 years 6.
6.Ability to understand and speak Dutch language
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Allergic reactions to intravenous iron therapy
2. Previous administration of IV iron therapy
3. Known hemochromatosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method