Disease activity and iron status in children with inflammatory bowel disease
- Conditions
- English: Inflammatory bowel disease, Disease activity, Iron, ChildrenDutch: Chronisch inflammatoire darmziekten, Ziekteactiviteit, IJzer, Kinderen
- Registration Number
- NL-OMON22615
- Lead Sponsor
- Haga Teaching Hospital/Juliana Children's Hospital, The HagueEls Borst-Eilersplein 275, 2545 AA The Hague, The NetherlandsTel nr.: +31 (0)70 2100000
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 133
Inclusion Criteria
Children up to18 years of age
- Diagnosis of IBD based on conventional endoscopic, histological and radiological criteria in accordance with the Porto-criteria
Exclusion Criteria
- Oncologic disorder
- Known hemoglobinopathies
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Iron deficiency (ID): a combination of absolute and functional ID. Absolute ID: serum ferritin (SF) <12 µg/l in patients <5 years of age and <15 µg/l in patients ≥5 years of age. This definition will be used in the absence of acute infection (i.e. CRP <10 mg/l). Functional ID: zinc protoporphyrin/heme ratio (ZnPP/H) >61 mmol/mol heme in patients <5 years of age and >70 mmol/mol heme in patients >5 years of age and/or red blood cell distribution width (RDW) >14 %. Functional ID will be determined in patients without absolute ID. The presence of disease activity will be determined based on FC-level. Active disease: FC-levels ≥250 µg/g, and No active disease: FC-levels <250 µg/g.
- Secondary Outcome Measures
Name Time Method Anemia will be defined as hemoglobin >2 standard deviations below the mean of similarly aged children according to criteria of the World Health Organization. Iron deficiency anemia (IDA) will be defined as absolute ID in combination with anemia. Anemia of chronic disease (ACD) will be defined as functional ID in combination with anemia. Vitamin D status will be based on 25[OH]D measurements. Vitamin D deficiency (VDD) will be defined as 25[OH]D <50 nmol/l (20 ng/ml).