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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03777904
Enrollment
11
Registered
2018-12-17
Start date
2019-02-21
Completion date
2019-12-10
Last updated
2022-04-05

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

Conditions

Iron Overload

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.

Interventions

DIAGNOSTIC_TESTSerum Ferritin level

Serum ferritin level will be collected with other clinical labs and measured in the research lab

DIAGNOSTIC_TESTSerum Ferritin iron content

Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab

DIAGNOSTIC_TESTUrine Ferritin level

Urine will be collected non-invasively and analyzed for ferritin level

DIAGNOSTIC_TESTUrine ferritin iron content

Urine will be collected non-invasively and analyzed for iron content within the ferritin

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Children with ferritin levels \> 1000 ng/mL

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Correlation of serum and urine ferritin levels1 yearSerum 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 levels1 yearSerum 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026