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

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.

Study Overview

• Status: Terminated
• Conditions: Iron Overload
• Intervention / Treatment: Diagnostic test: Serum Ferritin level; Diagnostic test: Serum Ferritin iron content; Diagnostic test: Urine Ferritin level; Diagnostic test: Urine ferritin iron content

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with high ferritin levels and confirmed iron toxicity.

Description

Inclusion Criteria:

• Children with ferritin levels > 1000 ng/mL

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Overload; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 00117617

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No