Disease activity and iron status in children with inflammatory bowel disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22615

Enrollment

133

Registered

2018-05-21

Start date

2018-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

English: Inflammatory bowel disease, Disease activity, Iron, Children Dutch: Chronisch inflammatoire darmziekten, Ziekteactiviteit, IJzer, Kinderen

Interventions

None

Eligibility

Inclusion criteria

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 - Written informed consent from parent(s)/ guardian and children themselves if ≥12 years who are capable of a reasonable valuation of their interests pertinent to the situation. - Parent(s)/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

Measure	Time frame
Iron deficiency (ID): a combination of absolute and functional ID. Absolute ID: serum ferritin (SF) 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 <250 µg/g.	—

Measure

Time frame

Iron deficiency (ID): a combination of absolute and functional ID. Absolute ID: serum ferritin (SF) 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 <250 µg/g.

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Secondary

Measure	Time 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 <50 nmol/l (20 ng/ml).	—

Measure

Time 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 <50 nmol/l (20 ng/ml).

—

Contacts

Public ContactM. Vreugdenhil

Haga Teaching Hospital/Juliana Children’s Hospital

M.Vreugdenhil@hagaziekenhuis.nl+31 (0)70 2108131

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)