Use 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
ID
Bron
Verkorte titel
Aandoening
IBD, pediatric, anemia, 6minute walking test ,physical fitness, parenteral iron, oral iron
Dutch: chronische darmziekte, kinderen, 6 minuten wandel test, fysieke gezondheid, intraveneuze ijzertoediening, orale ijzertoediening
Ondersteuning
Funding: Vifor Pharma
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome is the proportion of patients per group that show a 15% increase in 6 minute walking distance from study baseline.
Achtergrond van het onderzoek
At 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.
Doel van het onderzoek
Use 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
Onderzoeksopzet
Measurement of biochemistry and 6 MWT and questionnaires at 1, 3, 6 months after start of the study.
Onderzoeksproduct en/of interventie
Intervention is administration of ferric carboxymaltose versus oral iron adminstration for children who are anemic and suffering from IBD.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 µg/L
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4249 |
NTR-old | NTR4487 |
CCMO | NL42995.096.12 |
OMON | NL-OMON44995 |