NCT03816813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

March 22, 2019

Status Verified

January 1, 2019

Enrollment Period

3 days

First QC Date

January 21, 2019

Last Update Submit

March 20, 2019

Conditions

Hepcidin, Saliva

Outcome Measures

Primary Outcomes (3)

  • Saliva hepcidin

    Day 1am

  • Serum hepcidin

    Day 1am

  • Serum ferritin

    Iron Status parameter

    Day 1am

Secondary Outcomes (6)

  • Hemoglobin

    Day 1am

  • Transferrin receptor

    Day 1am

  • c-reactive protein

    Day 1am

  • alpha-glycoprotein

    Day 1am

  • Saliva hepcidin

    Day 1pm

  • +1 more secondary outcomes

Interventions

blood and saliva samplingOTHER

blood and saliva sampling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy volunteers, male and female

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Senior Scientist

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 25, 2019

Study Start

February 4, 2019

Primary Completion

February 7, 2019

Study Completion

February 7, 2019

Last Updated

March 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)