Administration of iron given intravenously versus orally in children with anemia and chronic inflammatory bowel disease.

Prospective Open Label study of Parenteral vs Enteral iron in Young IBD patients and Effect on physical fitness - POPEYE study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005644-26-BE

Enrollment

150

Registered

2017-12-21

Start date

2018-02-26

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia and fatigue in children with Inflammatory Bowel disease (IBD)

Interventions

Trade Name: Injectafer /ferinject. Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Current Sponsor cod

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children attending a pediatrician/ pediatric gastroenterologist/ gastro-enterologist. 2. Children aged 8 – 18 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. Are the trial subjects under 18? yes Number of subjects for this age range: 150 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

Exclusion criteria: 1. Allergic reactions to intravenous iron therapy 2. Suffering from hemochromatosis 3. Patients who received oral or IV iron therapy three months prior to the study 4. PUCAI > 65 - PCDAI > 30 (severe disease activity)

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To examine the effectiveness of intravenous administration of iron therapy, on improving hemoglobin (improvement of Hb with 1.25 mmol/L (2g/dl) in comparison to the Hb at the start of the study). To examine the effect of intravenous iron on physical fitness compared with usual care. To examine the effect of intravenous iron on quality of life and fatigue compared with usual care. To identify predictors for fatigue in children with IBD. To assess baseline physical activity levels and quality of life in children with IBD.;Timepoint(s) of evaluation of this end point: After 4 weeks, after 3 and after 6 months;Main Objective: The overall objective of the current application is to compare the effect of intravenous iron supplementation to oral supplementation on recovery of physical activity, anemia, subclinical inflammation, quality of life and fatigue.;Primary end point(s): Primary outcome is the proportion of patients per group that show a 15% increase in 6 minute walking distance after four weeks from study baseline. The six minute walk test (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 The patients are asked to walk up and down the measured lap at their best pace but not to run or race (47). With patients tested by the same technician, short-term reproducibility of the 6MWT is excellent. 6MWT is expressed as absolute distance in meters and is age and height dependent (31,32). Healthy children below 12 years show the steepest increase in 6MWD per year. After 12 years 6MWD further increases with age in boys, whereas it essentially levels off in girls (31). When several 6MWTs are done within a short time frame, 6 MWD usually reaches a plateau after two tests done within a week (33). This training effect may be due to improved coordination, finding optimal stride length, and overcoming anxiety. The possibility of a training effect from test	—

Measure

Time frame

Secondary Objective: To examine the effectiveness of intravenous administration of iron therapy, on improving hemoglobin (improvement of Hb with 1.25 mmol/L (2g/dl) in comparison to the Hb at the start of the study). To examine the effect of intravenous iron on physical fitness compared with usual care. To examine the effect of intravenous iron on quality of life and fatigue compared with usual care. To identify predictors for fatigue in children with IBD. To assess baseline physical activity levels and quality of life in children with IBD.;Timepoint(s) of evaluation of this end point: After 4 weeks, after 3 and after 6 months;Main Objective: The overall objective of the current application is to compare the effect of intravenous iron supplementation to oral supplementation on recovery of physical activity, anemia, subclinical inflammation, quality of life and fatigue.;Primary end point(s): Primary outcome is the proportion of patients per group that show a 15% increase in 6 minute walking distance after four weeks from study baseline. The six minute walk test (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 The patients are asked to walk up and down the measured lap at their best pace but not to run or race (47). With patients tested by the same technician, short-term reproducibility of the 6MWT is excellent. 6MWT is expressed as absolute distance in meters and is age and height dependent (31,32). Healthy children below 12 years show the steepest increase in 6MWD per year. After 12 years 6MWD further increases with age in boys, whereas it essentially levels off in girls (31). When several 6MWTs are done within a short time frame, 6 MWD usually reaches a plateau after two tests done within a week (33). This training effect may be due to improved coordination, finding optimal stride length, and overcoming anxiety. The possibility of a training effect from test

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Secondary

Measure	Time frame
Secondary end point(s): I. 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. II 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). 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. 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 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). The questionnaire is available in Dutch for children (8-12y) and adolescents (12-18y). The questionnaire comprises parallel child self-reports and parent proxyreports. 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. III Other 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 (Ht, cell indices, th	—

Measure

Time frame

Secondary end point(s): I. 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. II 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). 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. 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 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). The questionnaire is available in Dutch for children (8-12y) and adolescents (12-18y). The questionnaire comprises parallel child self-reports and parent proxyreports. 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. III Other 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 (Ht, cell indices, th

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Countries

Belgium, Netherlands

Contacts

Public ContactDr. Els Van de Vijver

Antwerp University Hospital

els.vandevijver@uza.be003238215524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026