Inflammatory Bowel Disease - chronic infection of the intestines
Conditions
Interventions
Intravenous administration of ferric carboxymaltose (intervention):
The study medication is ferric carboxymaltose or ijzercarboxymaltose in Dutch,
brand name Ferinject ® (The Netherlands) or Injectaf
Sponsors
Atrium Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: *1. Children attending a pediatrician/ pediatric gastro-enterologist/gastro-enterologist. 2. Children aged 8 * 20 years 3. Suffering from CD/CU/IBDU diagnosed according to the Porto criteria (1) 4. Written informed consent of both parents with authority or from custodial parent and if age> 12y: also from the child itself. 5. Ability to understand and speak Dutch language.
Exclusion criteria
Exclusion criteria: 1. Allergic reactions to intravenous iron therapy 2. Suffering from hemochromatosis or other iron overload disease 3. Patients who received oral/ intravenous iron therapy three months prior to the study 4. PUCAI > 65 - PCDAI > 30 (severe disease activity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8.1.1 Main study parameter/outcome Primary outcome is the proportion of patients per group that show a 15% increase in 6 minute walking distance from study baseline. The six minute walktest (6MWT) is an established method to assess exercise capacity. It is expressed as the distance a person can walk at a constant, uninterrupted pace in 6 minutes {2002 263 /id}. The patients are asked to walk up and down the measured lap at their best pace but not to run or race. With patients tested by the same technician, short-term reproducibility of the 6MWT is excellent {2002 263 /id}. 6MWT is expressed as absolute distance in meters and is age and height dependent {Geiger, 2007 557 /id;Lammers, 2008 558 /id}. | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.1.2 Secondary outcome variables: Secondary outcome variable in the study is an increase of Hb with 1.25 mmol/L (2 g/dl) one month after administration of IV ferric carboxymaltose therapy compared to the Hb level at time of inclusion Other secondary endpoints include the IMPACT-III score and the PEDSQL fatigue scale. The IMPACT-III score is a disease-specific quality of life score, composed of 35 items on 6 domains: IBD-related symptoms (7 items), systemic symptoms (3), emotional functioning (7), social functioning (12), body image (3) and treatment/intervention-related concerns (3).[26,27] Each item can be scored on a 5 point Likert scale, coded from 0 to 4 points. Higher scores indicate better quality of life. The IMPACT questionnaire is validated for use in children 8 years and older and is recommended for the evaluation of new therapies because of its high sensitivity to change. The IMPACT-III (NL) is a translated and modified version of the original Canadian questionnaire that used a visual analogue scale.[28,29] The Likert scale was introduced as it has been shown that children consider it easier to complete than a visual analogue scale. The PEDSQL fatigue scale: The developed 18-item PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in pediatric patients and comprises the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). (Varni, 2004) The questionnaire is available in Dutch for children (8-12y) and adolescents (12-18y). The questionnaire comprises parallel child self-reports and parent proxy-reports. The participants rate how often a particular problem occurred in the past month, using a 5-point Likert scale. Each item is reverse-scored and rescaled to 0-100 scale, so that higher scores indicate fewer symptoms of fatigue. Also monitored parameters are the clinical disease activity according to PCDAI and PUCAI, laboratory markers for effectiveness of | — |
Countries
Netherlands
Outcome results
None listed