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

NCT03777904 | Terminated

• 1 other identifier: 00117617
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Overload

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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; Diagnostic Test: Serum Ferritin iron content; Diagnostic Test: Urine Ferritin level; Diagnostic Test: Urine ferritin iron content

Interventions

Serum Ferritin level DIAGNOSTIC_TEST

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

Children with high serum ferritin

Serum Ferritin iron content DIAGNOSTIC_TEST

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

Children with high serum ferritin

Urine Ferritin level DIAGNOSTIC_TEST

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

Children with high serum ferritin

Urine ferritin iron content DIAGNOSTIC_TEST

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

Children with high serum ferritin

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with high ferritin levels and confirmed iron toxicity.

You may qualify if:

• Children with ferritin levels \> 1000 ng/mL

You may not qualify if:

• None

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert Christensen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: February 21, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

US (1)