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

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT03777904
Collaborator
(none)
11
1
9.6
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serum Ferritin level
  • Diagnostic Test: Serum Ferritin iron content
  • Diagnostic Test: Urine Ferritin level
  • Diagnostic Test: Urine ferritin iron content

Study Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
Actual Study Start Date :
Feb 21, 2019
Actual Primary Completion Date :
Dec 10, 2019
Actual Study Completion Date :
Dec 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Children with high serum ferritin

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children with ferritin levels > 1000 ng/mL
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Primary Children's Hospital Salt Lake City Utah United States 84113

Sponsors and Collaborators

  • University of Utah

Investigators

  • Principal Investigator: Robert Christensen, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Utah
ClinicalTrials.gov Identifier:
NCT03777904
Other Study ID Numbers:
  • 00117617
First Posted:
Dec 17, 2018
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022