Disease activity and iron status in children with inflammatory bowel disease

Completed

Conditions: Crohn's disease
Inflammatory bowel disease
ulcerative colitis
10002086
10017969

Registration Number: NL-OMON50423

Lead Sponsor: HagaZiekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 133

Inclusion Criteria

- Children (male and female), up to18 years of age.
- Diagnosis of IBD based on conventional endoscopic, histological and
radiological criteria in accordance with the Porto-criteria
- Written informed consent from parents/guardian and children themselves if >=12
years who are capable of a reasonable valuation of their interests pertinent to
the situation.
- Parents/guardian and pediatric IBD-patients understand the Dutch language

Exclusion Criteria

- Oncologic disorder
- Known hemoglobinopathies
- Congenital malformations
- Iron supplementation during the last 8 weeks
- Blood transfusion during the last 6 months
- Known liver disease
- Monogenic IBD

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Iron deficiency (ID): a combination of absolute and functional ID. Absolute ID:<br /><br>serum ferritin (SF) <12 µg/l in patients <5 years of age and <15 µg/l in<br /><br>patients >=5 years of age. This definition will be used in the absence of acute<br /><br>infection (i.e. CRP <10 mg/l). Functional ID: zinc protoporphyrin/heme ratio<br /><br>(ZnPP/H) >61 mmol/mol heme in patients <5 years of age and >70 mmol/mol heme in<br /><br>patients >5 years of age and/or red blood cell distribution width (RDW) >14 %.<br /><br>Functional ID will be determined in patients without absolute ID.<br /><br><br /><br>The presence of disease activity will be determined based on FC-level. Active<br /><br>disease: FC-levels >=250 µg/g, and No active disease: FC-levels <250 µg/g. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Anemia will be defined as hemoglobin >2 standard deviations below the mean of<br /><br>similarly aged children according to criteria of the World Health Organization.<br /><br>Iron deficiency anemia (IDA) will be defined as absolute ID in combination with<br /><br>anemia. Anemia of chronic disease (ACD) will be defined as functional ID in<br /><br>combination with anemia. Vitamin D status will be based on 25[OH]D<br /><br>measurements. Vitamin D deficiency (VDD) will be defined as 25[OH]D <50 nmol/l<br /><br>(20 ng/ml). </p><br>