Iron DeficiencyIronKidsNCT02701309
Non-invasive Optical Detection of Iron Deficiency in Children
An observational study of Iron Deficiency and Iron-deficiency Anemia, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa in children. The prototype device has shown high sensitivity and specificity in women after delivery for iron deficiency. Read more about this study
- Who is it for?
- Ages 9 months to 5 years
- Conditions the study is for
- Iron Deficiency, Iron-deficiency Anemia, Child
- What is being tested?
- Non-invasive Iron detection device via Zinc-Protoporphyrin
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2016to Sep 2016
- 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 9 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 9 months to 5 years
Who may be able to join
- Children aged 9 months to 5 years
- Planed blood sampling, independently from this study
- Informed written consent to participation´s guardian in the study
Who cannot join
- the ability of the guardian is not given to approve the consent
- transfusion of blood products before entering the study
- blood sampling is not planed for clinical investigations
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre
Munich, Bavaria, 80337
LMU Munich
Munich, Bavaria, 80337
About this study
Official title: Non-invasive Optical Detection of Iron Deficiency in Children- Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio
This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa in children. The prototype device has shown high sensitivity and specificity in women after delivery for iron deficiency. Children are at increased risk for iron deficiency and prevention methods are not established jet. Zinc protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than other established parameters. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are at increased risk for iron deficiency as they are growing rapidly and iron deficiency in this age may affect the neurodevelopment and immune system adversely. It is proposed that these effects cannot be rectified by iron supplementation in later years. The results from the non-invasive measurements are compared to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor.
Read the detailed description
This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra in children aged 9 months to 5 years and determine the erythrocyte zinc protoporphyrin-IX fluorescence intensity from these spectra. The non-invasively determined fluorescence spectra are evaluated to provide a quantitative measure of the erythrocyte zinc protoporphyrin-IX/heme concentration ratio. These values are primarily compared to an erythrocyte zinc protoporphyrin-IX determined by HPLC from residual blood samples from the same subjects and secondarily to erythrocyte zinc protoporphyrin-IX/heme ratios determined using a commercial hematofluorometer (AVIV, model 206d) and other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor
This study could help to establish the non-invasive fluorescence measurement of zinc protoporphyrin-IX as a rapid, easy to use means for point-of-care screening for iron deficiency in resource-limited settings lacking laboratory infrastructure.
- Conditions
- Iron Deficiency, Iron-deficiency Anemia, Child
- Being tested
- Non-invasive Iron detection device via Zinc-Protoporphyrin
- Keywords
- Iron deficiency, Child, Infancy, Preschool children, iron deficiency anemia
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Iron detection device via Zinc-ProtoporphyrinDevice
Also called Iron detection device
In this study the feasability, sensitivity and specifity of a non-invasive detection method of zinc-protoporphyrin in children is evaluated. It´s a one-arm study, without control Group. Children are aged between 9m and 5y and have a clinical blood sampling indicated.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Iron detection | Children between 9months and 5years will be recruited for a non-invasive iron measurement on the lower lip. This study is focusing on the feasability of a non-invasive detection method. There is no intervention planed. The device is tested once for 3-5 Minutes. Receives: Device: Non-invasive Iron detection device via Zinc-Protoporphyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)
Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with reference standard determinations of erythrocyte zinc protoporphyrin IX in blood samples by high performance liquid chromatography (HPLC).
Measured: 1 day after measurement
Secondary outcomes (1)
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity)
Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with an estimate of total body iron, determined from the logarithm of the soluble transferrin receptor/ferritin ratio.
Measured: 1 day after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koletzko - Office, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof.Dr.med., Principal investigator, LMU Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701309
- Sponsor's protocol ID
- LFL_02/2015
- Acronym
- IronKids
- Status last verified
- Sep 2016
- First submitted
- 2 Mar 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The principal investigator (PI, Prof. Dr. Dr. B. Koletzko) has access to the study data. The data may be shared with other researchers for specific research purposes if a written request with detailed description of objectives and goals, workplan and statistical analysis plan, strategy to protect data from other uses, publication strategy, and description of the research team and its qualification is provided. Based on the evaluation of proposals, the PI and study team will decided on a case by case basis which data can be provided.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Optical Detection of Iron Deficiency in Children- Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio
- ClinicalTrials.gov ID
- NCT02701309
- Acronym / sponsor ID
- IronKids / LFL_02/2015
- Conditions
- Iron Deficiency, Iron-deficiency Anemia, Child
- Keywords
- Iron deficiency, Child, Infancy, Preschool children, iron deficiency anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa in children. The prototype device has shown high sensitivity and specificity in women after delivery for iron deficiency. Children are at increased risk for iron deficiency and prevention methods are not established jet. Zinc protoporphyrin-IX is an early indicator of iron deficiency and may be more sensitive than other established parameters. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio in children aged 9 months to 5 years. Children in this age are at increased risk for iron deficiency as they are growing rapidly and iron deficiency in this age may affect the neurodevelopment and immune system adversely. It is proposed that these effects cannot be rectified by iron supplementation in later years. The results from the non-invasive measurements are compared to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor.
Detailed description
This trial is a proof-of-concept study using a prototype fiber optic fluorometer to acquire autofluorescence spectra in children aged 9 months to 5 years and determine the erythrocyte zinc protoporphyrin-IX fluorescence intensity from these spectra. The non-invasively determined fluorescence spectra are evaluated to provide a quantitative measure of the erythrocyte zinc protoporphyrin-IX/heme concentration ratio. These values are primarily compared to an erythrocyte zinc protoporphyrin-IX determined by HPLC from residual blood samples from the same subjects and secondarily to erythrocyte zinc protoporphyrin-IX/heme ratios determined using a commercial hematofluorometer (AVIV, model 206d) and other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor
This study could help to establish the non-invasive fluorescence measurement of zinc protoporphyrin-IX as a rapid, easy to use means for point-of-care screening for iron deficiency in resource-limited settings lacking laboratory infrastructure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Iron detection | – | Device: Non-invasive Iron detection device via Zinc-ProtoporphyrinChildren between 9months and 5years will be recruited for a non-invasive iron measurement on the lower lip. This study is focusing on the feasability of a non-invasive detection method. There is no intervention planed. The device is tested once for 3-5 Minutes. |
Who may qualify
- Ages
- 9 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 9 months to 5 years
Key inclusion criteria (3 listed)
- Children aged 9 months to 5 years
- Planed blood sampling, independently from this study
- Informed written consent to participation´s guardian in the study
Key exclusion criteria (3 listed)
- the ability of the guardian is not given to approve the consent
- transfusion of blood products before entering the study
- blood sampling is not planed for clinical investigations
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 |
|---|---|---|
| Non-invasive Iron detection device via Zinc-ProtoporphyrinAlso: Iron detection deviceIn this study the feasability, sensitivity and specifity of a non-invasive detection method of zinc-protoporphyrin in children is evaluated. It´s a one-arm study, without control Group. Children are aged between 9m and 5y and have a clinical blood sampling indicated. | Device | Non-invasive Iron detection |
Primary outcome
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)
Time frame: 1 day after measurement
Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with reference standard determinations of erythrocyte zinc protoporphyrin IX in blood samples by high performance liquid chromatography (HPLC).
1 secondary outcome
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity)
Time frame: 1 day after measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: Undecided. The principal investigator (PI, Prof. Dr. Dr. B. Koletzko) has access to the study data. The data may be shared with other researchers for specific research purposes if a written request with detailed description of objectives and goals, workplan and statistical analysis plan, strategy to protect data from other uses, publication strategy, and description of the research team and its qualification is provided. Based on the evaluation of proposals, the PI and study team will decided on a case by case basis which data can be provided.
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Iron Absorption From a Nutritional Iron Supplement
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RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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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.
Berthold Koletzko, Prof.Dr.med. principal investigator
LMU Munich, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency and Iron-deficiency Anemia, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity) (time frame: 1 day after measurement). 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 8 Sep 2016.