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

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ClinicalTrials.gov Identifier: NCT03777904
Recruitment Status : Unknown
Verified December 2018 by University of Utah.
Recruitment status was:  Recruiting
First Posted : December 17, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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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
Iron Overload Diagnostic Test: Serum Ferritin level Diagnostic Test: Serum Ferritin iron content Diagnostic Test: Urine Ferritin level Diagnostic Test: Urine ferritin iron content

Study Design
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Study Type : Observational
Estimated Enrollment : 20 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 : February 21, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of serum and urine ferritin levels [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with high ferritin levels and confirmed iron toxicity.
Criteria

Inclusion Criteria:

  • Children with ferritin levels > 1000 ng/mL

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777904


Contacts
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Contact: Robert Christensen, MD 801-581-7052 robert.christensen@hsc.utah.edu

Locations
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United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Robert Christensen, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Robert Christensen, MD University of Utah
More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03777904    
Other Study ID Numbers: 00117617
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron
 Trace Elements
Micronutrients
Physiological Effects of Drugs