Skip to content

Disease activity and iron status in children with inflammatory bowel disease

Disease activity and iron status in children with inflammatory bowel disease - DISIRO-IBD study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50423
Enrollment
133
Registered
2018-04-16
Start date
2018-08-13
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Crohn's disease Inflammatory bowel disease ulcerative colitis

Interventions

None listed

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Iron deficiency (ID): a combination of absolute and functional ID. Absolute ID: serum ferritin (SF) =5 years of age. This definition will be used in the absence of acute infection (i.e. CRP 61 mmol/mol heme in patients 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

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)