An observational study in Iron Overload, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by University of Utah · Observational
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.
156 studies on the registry are indexed under Iron Overload; 6 are open to participants now.
This study's enrollment of 11 is below the median of 94 across 49 observational studies indexed under Iron Overload.
Browse Iron Overload studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Children with high ferritin levels and confirmed iron toxicity.
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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
Serum ferritin level will be collected with other clinical labs and measured in the research lab
Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab
Urine will be collected non-invasively and analyzed for ferritin level
Urine will be collected non-invasively and analyzed for iron content within the ferritin
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
Time frame: 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
Time frame: 1 year
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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