Assessement of Hepcidin in Saliva in Human Volunteers

Hepcidin, Saliva Clinical Trial

Official title:

Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816813
• Other study ID #: HepSa
• Status: Completed
• Start date: February 4, 2019
• Est. completion date: February 7, 2019

Study information

• Verified date: January 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepcidin, Saliva

Intervention

Other:
• blood and saliva sampling
blood and saliva sampling

Locations

Country	Name	City	State
Switzerland	Laboratory of Human Nutrition	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva hepcidin		Day 1am
Primary	Serum hepcidin		Day 1am
Primary	Serum ferritin	Iron Status parameter	Day 1am
Secondary	Hemoglobin		Day 1am
Secondary	Transferrin receptor	Iron Status parameter	Day 1am
Secondary	c-reactive protein	Inflammation parameter	Day 1am
Secondary	alpha-glycoprotein	Inflammation parameter	Day 1am
Secondary	Saliva hepcidin	to assess variability in saliva hepcidin during the day	Day 1pm
Secondary	Saliva hepcidin	to assess variability in saliva hepcidin in two samples measured at the same time of the day	Day 2am