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

NCT03777904 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2022-04-05

No results posted yet for this study

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.

Conditions

  • Iron Overload

Interventions

DIAGNOSTIC_TEST

Serum Ferritin level

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

DIAGNOSTIC_TEST

Serum 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_TEST

Urine Ferritin level

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

DIAGNOSTIC_TEST

Urine ferritin iron content

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

Sponsors & Collaborators

Principal Investigators

  • Robert Christensen, MD · University of Utah

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2019-12-10
Completion
2019-12-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777904 on ClinicalTrials.gov