Assessement of Hepcidin in Saliva in Human Volunteers

Completed

• Conditions: Hepcidin, Saliva

• Registration Number: NCT03816813
• Lead Sponsor: Swiss Federal Institute of Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2019-02-04
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ferritin	Day 1am	Iron Status parameter
Saliva hepcidin	Day 1am
Serum hepcidin	Day 1am

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratory of Human Nutrition; 🇨🇭 Zürich, Switzerland