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

Iron Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03777904
• Other study ID #: 00117617
• Status: Terminated
• Start date: February 21, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: March 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Children with ferritin levels > 1000 ng/mL

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Iron Overload

Intervention

Diagnostic Test:
• Serum Ferritin level
Serum ferritin level will be collected with other clinical labs and measured in the research lab
• 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
• Urine Ferritin level
Urine will be collected non-invasively and analyzed for ferritin level
• Urine ferritin iron content
Urine will be collected non-invasively and analyzed for iron content within the ferritin

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of serum and urine ferritin levels	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	1 year
Primary	Correlation of iron content within serum and urine ferritin levels	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	1 year