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NCT03777904 · ClinicalTrials.gov registry record
The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
A clinical trial, sponsored by University of Utah.
- Terminated
- Registry status
- 11
- Enrollment target
NCT03777904: Clinical Trial study, sponsored by University of Utah.
NCT03777904 is a clinical trial that was terminated before completion, run by University of Utah. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03777904 was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DIAGNOSTIC_TEST Serum Ferritin level
- DIAGNOSTIC_TEST Serum Ferritin iron content
- DIAGNOSTIC_TEST Urine Ferritin level
- DIAGNOSTIC_TEST Urine ferritin iron content
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2019-12-10 |
Why NCT03777904 stopped before completion
NCT03777904 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Serum Ferritin level is the first listed.
NCT03777904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03777904 about?
NCT03777904 is a clinical study titled "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 acut...
What is the current status of trial NCT03777904?
This trial is currently terminated. The enrollment target is 11 participants. The study started on 2019-02-21. Estimated completion is 2019-12-10.
What interventions are being tested in trial NCT03777904?
The interventions under investigation include: Serum Ferritin level (DIAGNOSTIC_TEST), Serum Ferritin iron content (DIAGNOSTIC_TEST), Urine Ferritin level (DIAGNOSTIC_TEST), Urine ferritin iron content (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03777904?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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