Assessement of Hepcidin in Saliva in Human Volunteers

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03816813
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Days): 3
• Patients Per Site Per Month: 913.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepcidin, Saliva	Other: blood and saliva sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency
• Actual Study Start Date: Feb 4, 2019
• Actual Primary Completion Date: Feb 7, 2019
• Actual Study Completion Date: Feb 7, 2019

Outcome Measures

Primary Outcome Measures

1. Saliva hepcidin [Day 1am]

2. Serum hepcidin [Day 1am]

3. Serum ferritin [Day 1am]

   Iron Status parameter

Secondary Outcome Measures

1. Hemoglobin [Day 1am]

2. Transferrin receptor [Day 1am]

   Iron Status parameter

3. c-reactive protein [Day 1am]

   Inflammation parameter

4. alpha-glycoprotein [Day 1am]

   Inflammation parameter

5. Saliva hepcidin [Day 1pm]

   to assess variability in saliva hepcidin during the day

6. Saliva hepcidin [Day 2am]

   to assess variability in saliva hepcidin in two samples measured at the same time of the day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Human Nutrition	Zürich		Switzerland	8092

Sponsors and Collaborators

• Swiss Federal Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diego Moretti, PhD, Senior Scientist, Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03816813
• Other Study ID Numbers: HepSa
• First Posted: Jan 25, 2019
• Last Update Posted: Mar 22, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 22, 2019