Iron-deficiencyZnPPNCT03231865
Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
An observational study of Iron-deficiency, run by Philipp Stein at 1 site in Switzerland.
Trial summary
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. 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
- What is being tested?
- Non-invasive measurement of ZincProtoporphyrin IX
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jul 2017to 31 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: Patients prior to a surgery, seen in the Anesthetic clinic for evaluation
Who may be able to join
- Patients seen preoperatively in the Anesthestic clinic
- Patients > 18 years of age
- Understood and signed patient consent
Who cannot join
- transfusion of blood products 8 weeks prior to screening
- Pregnancy
- Porphyria
Trial locations and contacts
1 site in 1 country.
About this study
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.
Read the detailed description
Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).
The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood.
The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.
- Conditions
- Iron-deficiency
- Being tested
- Non-invasive measurement of ZincProtoporphyrin IX
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive measurement of ZincProtoporphyrin IXDiagnostic test
Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value
| Study group | Role | What they receive |
|---|---|---|
| Preoperative patients | Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility. Receives: Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the non-invasive ZincProtoporphyrinIX measurement
The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood
Measured: Baseline
Secondary outcomes (1)
Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters
The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start27 Jul 2017
- Primary completion26 Feb 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Philipp Stein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philipp Stein, University of Zurich
- Investigators
- Philipp Stein, MD, Principal investigator, Institute of Anesthesiology, University and University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231865
- Sponsor's protocol ID
- 2017-00054
- Other IDs
- 2017
- Acronym
- ZnPP
- Status last verified
- Jun 2018
- First submitted
- 24 Jul 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.
PubMed 26883939
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX
- ClinicalTrials.gov ID
- NCT03231865
- Acronym / sponsor ID
- ZnPP / 2017-00054
- Conditions
- Iron-deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Philipp SteinUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 27 Jul 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.
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non invasively. Non invasive and invasive optical measurement of ZnPP will be compared. Additionally ZnPP measurements will be compared to other iron deficiency parameters for validation by the investigators.
Detailed description
Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).
The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole blood.
The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin saturation and soluble Transferrin receptor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative patients | – | Diagnostic Test: Non-invasive measurement of ZincProtoporphyrin IXPatients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prior to a surgery, seen in the Anesthetic clinic for evaluation
Key inclusion criteria (3 listed)
- Patients seen preoperatively in the Anesthestic clinic
- Patients > 18 years of age
- Understood and signed patient consent
Key exclusion criteria (3 listed)
- transfusion of blood products 8 weeks prior to screening
- Pregnancy
- Porphyria
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 measurement of ZincProtoporphyrin IXWithin 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value | Diagnostic test | Preoperative patients |
Primary outcome
Validation of the non-invasive ZincProtoporphyrinIX measurement
Time frame: Baseline
The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood
1 secondary outcome
Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters
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 8 Jun 2018.
- Background: PubMed 26883939Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.
- Individual participant dataSharing planned: Undecided
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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.
Philipp Stein, MD principal investigator
Institute of Anesthesiology, University and University Hospital Zurich
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, run by Philipp Stein at 1 site in Switzerland.
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 Jun 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 Switzerland. 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?
Validation of the non-invasive ZincProtoporphyrinIX measurement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231865, which also lists 1 linked publication.
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 Jun 2018.