Hepcidin, SalivaNCT03816813
Assessement of Hepcidin in Saliva in Human Volunteers
An observational study of Hepcidin, Saliva, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hepcidin, Saliva
- What is being tested?
- blood and saliva sampling
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Feb 2019to 7 Feb 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 18 to 45 years
- All sexes
- Adult
Study population: healthy volunteers, male and female
Who may be able to join
- Normal-weight (BMI 18-24.9kg/m2)
- fasting
- Participants Need to have brushed their teeth at least 1 hour before the visit
Who cannot join
- acute, chronic illness
- use of long-term medication other than contraception
- medical Problems known to affect Fe homeostasis
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency
Iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive fluid for disease biomarker discovery and diagnostic efforts, because it is readily available from most individuals, can be easily collected and the collection procedure is non-invasive. The iron storage protein ferritin is too big, to be secreted into saliva. However, the main iron regulatory protein hepcidin is a very small protein and there is some evidence for hepcidin detection in saliva. The production of serum hepcidin positively correlates with serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs to be tested.
- Conditions
- Hepcidin, Saliva
- Being tested
- blood and saliva sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and saliva samplingOther
blood and saliva sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva hepcidin
Measured: Day 1am
Serum hepcidin
Measured: Day 1am
Serum ferritin
Iron Status parameter
Measured: Day 1am
Secondary outcomes (6)
Hemoglobin
Measured: Day 1am
Transferrin receptor
Iron Status parameter
Measured: Day 1am
c-reactive protein
Inflammation parameter
Measured: Day 1am
alpha-glycoprotein
Inflammation parameter
Measured: Day 1am
Saliva hepcidin
to assess variability in saliva hepcidin during the day
Measured: Day 1pm
Saliva hepcidin
to assess variability in saliva hepcidin in two samples measured at the same time of the day
Measured: Day 2am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start4 Feb 2019
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepcidin, SalivaStudies 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Moretti, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816813
- Sponsor's protocol ID
- HepSa
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency
- ClinicalTrials.gov ID
- NCT03816813
- Acronym / sponsor ID
- HepSa
- Conditions
- Hepcidin, Saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 25 Jan 2019 (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.
Iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive fluid for disease biomarker discovery and diagnostic efforts, because it is readily available from most individuals, can be easily collected and the collection procedure is non-invasive. The iron storage protein ferritin is too big, to be secreted into saliva. However, the main iron regulatory protein hepcidin is a very small protein and there is some evidence for hepcidin detection in saliva. The production of serum hepcidin positively correlates with serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs to be tested.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- healthy volunteers, male and female
Key inclusion criteria (3 listed)
- Normal-weight (BMI 18-24.9kg/m2)
- fasting
- Participants Need to have brushed their teeth at least 1 hour before the visit
Key exclusion criteria (4 listed)
- acute, chronic illness
- use of long-term medication other than contraception
- medical Problems known to affect Fe homeostasis
- smoking
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 |
|---|---|---|
| blood and saliva samplingblood and saliva sampling | Other | – |
Primary outcome
Saliva hepcidin
Time frame: Day 1am
Serum hepcidin
Time frame: Day 1am
Serum ferritin
Time frame: Day 1am
Iron Status parameter
6 secondary outcomes
Hemoglobin
Time frame: Day 1am
Transferrin receptor
Time frame: Day 1am
c-reactive protein
Time frame: Day 1am
alpha-glycoprotein
Time frame: Day 1am
Saliva hepcidin
Time frame: Day 1pm
Saliva hepcidin
Time frame: Day 2am
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 22 Mar 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepcidin, Saliva, run by Swiss Federal Institute of Technology 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 4 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 22 Mar 2019. 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?
Saliva hepcidin (time frame: Day 1am). The study lists 3 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 22 Mar 2019.