Iron-deficiencyNCT03071497
Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX
An observational study of Iron-deficiency and Anemia, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Anemia, Iron Deficiency Anemia
- What is being tested?
- Non-invasive analysis of Zinc protoporphyrin
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2017to 1 May 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients preoperatively screened for anemia in the anemia walk-in clinic of the University Hospital Frankfurt that fit the inclusion criteria will be asked to participate in the study.
Who may be able to join
- Age > 18 years
Who cannot join
- Patients who received a blood transfusion less than 8 weeks before examination
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590
About this study
- In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion.
- A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure.
- Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID.
- This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients.
- Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).
Read the detailed description
The non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. In brief, light (restricted wavelengths: 407 / 425nm) will be used to excite ZnPP molecules within the blood of the oral mucosa by means of an optical fibre prob. The outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a ZnPP value [unit: µmol/mol heme] using mathematical transformations as well as spectral fitting.
This study compares the diagnostic performance of iron deficiency based on non-invasive measurements of Zinc protoporphyrin with results based on standard laboratory procedure (i.e. ZnPP measured in whole blood sample using HPLC) and blood values assessed during clinical routine, respectively.
If results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.
- Conditions
- Iron-deficiency, Anemia, Iron Deficiency Anemia
- Being tested
- Non-invasive analysis of Zinc protoporphyrin
- Keywords
- Iron-deficiency, Anemia, Iron-deficiency Anemia, Zinc protoporphyrin
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive analysis of Zinc protoporphyrinDiagnostic test
In patients fitting the inclusion criteria Zinc protoporphyrin will be measured non-invasively as proxy for iron deficiency. Results will be compared to ZnPP reference values measured via HPLC and with spectroscopical measurements performed on whole blood as well as with blood values (HB, MCH, MCV, ferritin, CRP, transferrin saturation, soluble transferrin receptor) assessed during clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Detecting iron deficiency using various methods. All patients that fit the inclusion criteria and are willing to participate in the study will be included in this group. Receives: Diagnostic Test: Non-invasive analysis of Zinc protoporphyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zinc protoporphyrin blood concentration (non-invasive measurement)
Using the prototype device Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured non-invasively in the oral mucosa.
Concentrations will be compared (Spearman's Rho, sensitivity, specificity) with Zinc protoporphyrin measurements of whole blood samples (see outcome 2 and 3).
Measured: Baseline
Secondary outcomes (2)
Zinc protoporphyrin blood concentration (HPLC reference measurement)
Using HPLC, the analytical reference method, Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.
Measured: Baseline
Zinc protoporphyrin blood concentration (spectroscopic measurement)
Using fluorescence spectroscopic methods Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured in whole blood samples.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start3 Mar 2017
- Primary completion1 May 2018
- Study completion1 May 2018
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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital
- Investigators
- Patrick Meybohm, Prof. Dr., Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071497
- Sponsor's protocol ID
- 468/16
- Status last verified
- Jul 2018
- First submitted
- 25 Feb 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX
- ClinicalTrials.gov ID
- NCT03071497
- Acronym / sponsor ID
- 468/16
- Conditions
- Iron-deficiency, Anemia, Iron Deficiency Anemia
- Keywords
- Iron-deficiency, Anemia, Iron-deficiency Anemia, Zinc protoporphyrin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 7 Mar 2017 (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.
- In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion.
- A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure.
- Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID.
- This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients.
- Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).
Detailed description
The non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. In brief, light (restricted wavelengths: 407 / 425nm) will be used to excite ZnPP molecules within the blood of the oral mucosa by means of an optical fibre prob. The outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a ZnPP value [unit: µmol/mol heme] using mathematical transformations as well as spectral fitting.
This study compares the diagnostic performance of iron deficiency based on non-invasive measurements of Zinc protoporphyrin with results based on standard laboratory procedure (i.e. ZnPP measured in whole blood sample using HPLC) and blood values assessed during clinical routine, respectively.
If results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Non-invasive analysis of Zinc protoporphyrinDetecting iron deficiency using various methods. All patients that fit the inclusion criteria and are willing to participate in the study will be included in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients preoperatively screened for anemia in the anemia walk-in clinic of the University Hospital Frankfurt that fit the inclusion criteria will be asked to participate in the study.
Key inclusion criteria (1 listed)
- Age > 18 years
Key exclusion criteria (2 listed)
- Patients who received a blood transfusion less than 8 weeks before examination
- Pregnancy
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 analysis of Zinc protoporphyrinIn patients fitting the inclusion criteria Zinc protoporphyrin will be measured non-invasively as proxy for iron deficiency. Results will be compared to ZnPP reference values measured via HPLC and with spectroscopical measurements performed on whole blood as well as with blood values (HB, MCH, MCV, ferritin, CRP, transferrin saturation, soluble transferrin receptor) assessed during clinical routine. | Diagnostic test | Study Group |
Primary outcome
Zinc protoporphyrin blood concentration (non-invasive measurement)
Time frame: Baseline
Using the prototype device Zinc protoporphyrin blood concentration [unit: µmol/mol heme] will be measured non-invasively in the oral mucosa. Concentrations will be compared (Spearman's Rho, sensitivity, specificity) with Zinc protoporphyrin measurements of whole blood samples (see outcome 2 and 3).
2 secondary outcomes
Zinc protoporphyrin blood concentration (HPLC reference measurement)
Time frame: Baseline
Zinc protoporphyrin blood concentration (spectroscopic measurement)
Time frame: Baseline
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 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Iron-deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
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
Heart Failure, Iron Deficiency
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.
Patrick Meybohm, Prof. Dr. principal investigator
Johann Wolfgang Goethe University Hospital
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-deficiency and Anemia, run by Johann Wolfgang Goethe University Hospital at 1 site 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 1 inclusion and 2 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 17 Jul 2018. 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 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?
Zinc protoporphyrin blood concentration (non-invasive measurement) (time frame: Baseline). 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 17 Jul 2018.