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Studie naar de effectiviteit van ijzer dat via de ader wordt gegevens ten opzichte van ijzer dat via de mond wordt gegeven bij kinderen met een chronische darmziekte.


- candidate number17137
- NTR NumberNTR4487
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-apr-2014
- Secondary IDsNL42995.096.12  CCMO
- Public TitleStudie naar de effectiviteit van ijzer dat via de ader wordt gegevens ten opzichte van ijzer dat via de mond wordt gegeven bij kinderen met een chronische darmziekte.
- Scientific TitleProspective Open Label study of Parenteral versus oral Iron in Young Ibd patients and effect on physical fitness.
- ACRONYMPOPEYE study
- hypothesisUse of IV iron: 1. improves exercise capacity quicker than oral iron; 2. causes a quicker rise in Hb than oral iron; 3. replenishes body iron stores better than oral iron; 4. reduces fatigue scores quicker than oral iron
- Healt Condition(s) or Problem(s) studiedIBD, Inflammatory bowel disease, Children, Parenteral iron, Oral iron
- Inclusion criteria1. Children attending a pediatrician/ pediatric gastro-enterologist 2. Children aged 8 18 years 3. Suffering from CD/CU (diagnosed according to Porto criteria) (1) 4. Written informed consent of both parents with authority or from legal guardian and if age> 12y: also from the child itself 5. Ability to understand and speak Dutch language 6. Hemoglobin level below 2 SD for gender and age (see appendix 2) 7.Ferritin ≤ 50 g/L
- Exclusion criteria1. 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)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2016
- Target number of participants80
- InterventionsIntervention is administration of ferric carboxymaltose versus oral iron adminstration for children who are anemic and suffering from IBD.
- Primary outcomePrimary outcome is the proportion of patients per group that show a 15% increase in 6 minute walking distance from study baseline.
- Secondary outcomeSecondary 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. Also monitored parameters are the clinical disease activity according to PCDAI and PUCAI, laboratory markers for effectiveness of IV iron therapy in replenishment of iron stores/biomarkers for iron stores (Ht, cell indices, thrombocytes, ferritin, transferrin, serum iron level, transferrin saturation, reticulocytes , sTfR, CRP, soluble transferrin receptors to log ferritin (sTfR-F ratio), transferrin/log ferritin ratio, hepcidin), side effects of IV iron therapy on liver functioning (AST, ALT, AF, total protein, albumin) and side effects on electrolyte homeostasis (phosphate).
- TimepointsMeasurement of biochemistry and 6 MWT and questionnaires at 1, 3, 6 months after start of the study.
- Trial web sitewww.popeyestudie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N. Bevers
- CONTACT for SCIENTIFIC QUERIES N. Bevers
- Sponsor/Initiator Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medical Center, Heerlen, Vifor Pharma
- Publications-
- Brief summaryAt the time that children are diagnosed with inflammatory bowel disease (IBD) over 80% of them are anemic with iron deficiency being the most common cause. Despite reaching remission, fatigue and decreased physical fitness continue to disturb activities of daily living. For children, this can be the most debilitating aspect of their disease. In order to replete empty iron stores administration of iron is recommended, yet the preferred route of administration has not been determined in children. Data about efficacy and optimal timing of IV and oral iron administration in pediatric patients are lacking. We hypothesize that children with IDA receiving IV iron therapy in comparison to oral iron therapy will have faster recovery from anemia in terms of Hb and other hematologic parameters and perform better in tests for fitness and score lower in fatigue scales.
- Main changes (audit trail)
- RECORD3-apr-2014 - 25-apr-2014


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