The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels

Terminated

• Conditions: Iron Overload
• Interventions: Diagnostic Test: Serum Ferritin level; Diagnostic Test: Serum Ferritin iron content; Diagnostic Test: Urine Ferritin level; Diagnostic Test: Urine ferritin iron content

• Registration Number: NCT03777904
• Lead Sponsor: University of Utah

Brief Summary

A serum ferritin level can reflect the total body iron content, thus a very low serum ferritin is commonly used as an indicator of iron deficiency and a very high serum ferritin is commonly used as a marker of iron overload. Ferritin is a shell of protein in which iron is stored. Ferritin is an acute phase reactant, and serum ferritin levels can increase during inflammatory conditions. Consequently, an elevated ferritin level might mean there is an excess of storage iron, or might simply mean that inflammation has resulted in high levels of the ferritin shell, containing little iron.

The research team is able to quantify the amount of iron in ferritin using inductively conducted plasma mass spectrometry, in the Heme and Iron Core Laboratory at the University of Utah. Thus, it can be determined whether in a child with a very high serum ferritin level, that ferritin is loaded with iron or is actually very low in iron. Neonates and young children with certain liver disorders characteristically have a very high serum ferritin level. These conditions are gestational alloimmune liver disease (GALD) and hemophagocytic lymphohistiocytosis (HLH). It is not clear what the iron content of the ferritin is in these neonates. Knowing this will be a step toward understanding whether the pathogenesis of these conditions involves iron overload. Additionally, if urine ferritin and iron levels correlate with serum ferritin and iron levels, urine may be used as a non-invasive way to monitor iron status.

In this study, serum and urine samples will be collected from children with high serum ferritin levels and confirmed iron toxicity. Both ferritin and iron content within ferritin will be measured in the serum and urine samples and compared for correlation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-17
• Study Start: 2019-02-21
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Children with ferritin levels > 1000 ng/mL

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with high serum ferritin	Urine ferritin iron content	Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.
Children with high serum ferritin	Serum Ferritin level	Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.
Children with high serum ferritin	Serum Ferritin iron content	Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.
Children with high serum ferritin	Urine Ferritin level	Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.

Primary Outcome Measures

Name	Time	Method
Correlation of serum and urine ferritin levels	1 year	Serum levels of ferritin will be compared to urine ferritin levels to evaluate whether urine can be used to calculate ferritin levels in the body non-invasively
Correlation of iron content within serum and urine ferritin levels	1 year	Serum iron content of ferritin will be compared to urine iron content of ferritin levels to evaluate whether urine can be used to calculate total body iron content non-invasively

Trial Locations

Locations (1)

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States