Iron OverloadNCT03777904
The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
An observational study of Iron Overload, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Iron Overload
- What is being tested?
- Serum Ferritin level, Serum Ferritin iron content and Urine Ferritin level
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 10 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with high ferritin levels and confirmed iron toxicity.
Who may be able to join
- Children with ferritin levels > 1000 ng/mL
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
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
- Being tested
- Serum Ferritin level, Serum Ferritin iron content, Urine Ferritin level, Urine ferritin iron content
- Medical subject headings
- Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Ferritin levelDiagnostic test
Serum ferritin level will be collected with other clinical labs and measured in the research lab
Serum Ferritin iron contentDiagnostic test
Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab
Urine Ferritin levelDiagnostic test
Urine will be collected non-invasively and analyzed for ferritin level
Urine ferritin iron contentDiagnostic test
Urine will be collected non-invasively and analyzed for iron content within the ferritin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum Ferritin level; Diagnostic Test: Serum Ferritin iron content; Diagnostic Test: Urine Ferritin level; Diagnostic Test: Urine ferritin iron content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start21 Feb 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Why it stopped: Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Christensen, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777904
- Sponsor's protocol ID
- 00117617
- Status last verified
- Mar 2022
- First submitted
- 14 Dec 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
- ClinicalTrials.gov ID
- NCT03777904
- Acronym / sponsor ID
- 00117617
- Conditions
- Iron Overload
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with high serum ferritin | – | Diagnostic Test: Serum Ferritin level, Diagnostic Test: Serum Ferritin iron content, Diagnostic Test: Urine Ferritin level, Diagnostic Test: Urine ferritin iron contentChildren 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with high ferritin levels and confirmed iron toxicity.
Key inclusion criteria (1 listed)
- Children with ferritin levels > 1000 ng/mL
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Ferritin levelSerum ferritin level will be collected with other clinical labs and measured in the research lab | Diagnostic test | Children with high serum ferritin |
| Serum Ferritin iron contentBlood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab | Diagnostic test | Children with high serum ferritin |
| Urine Ferritin levelUrine will be collected non-invasively and analyzed for ferritin level | Diagnostic test | Children with high serum ferritin |
| Urine ferritin iron contentUrine will be collected non-invasively and analyzed for iron content within the ferritin | Diagnostic test | Children with high serum ferritin |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Christensen, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Overload, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of serum and urine ferritin levels (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.