Assessement of Hepcidin in Saliva in Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Hepcidin, Saliva
• Intervention / Treatment: Other: blood and saliva sampling

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8092
    • Laboratory of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy volunteers, male and female

Description

Inclusion Criteria:

• Normal-weight (BMI 18-24.9kg/m2)
• fasting
• Participants Need to have brushed their teeth at least 1 hour before the visit

Exclusion Criteria:

• acute, chronic illness
• use of long-term medication other than contraception
• medical Problems known to affect Fe homeostasis
• smoking

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva hepcidin		Day 1am
Serum hepcidin		Day 1am
Serum ferritin	Iron Status parameter	Day 1am

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin		Day 1am
Transferrin receptor	Iron Status parameter	Day 1am
c-reactive protein	Inflammation parameter	Day 1am
alpha-glycoprotein	Inflammation parameter	Day 1am
Saliva hepcidin	to assess variability in saliva hepcidin during the day	Day 1pm
Saliva hepcidin	to assess variability in saliva hepcidin in two samples measured at the same time of the day	Day 2am

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HepSa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No