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OpenTrials
Completed

NCT Number: NCT03816813

Assessement of Hepcidin in Saliva in Human Volunteers

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood and saliva sampling

Other

blood and saliva sampling

Primary outcomes

  1. Saliva hepcidin

    Time frame: Day 1am

  2. Serum hepcidin

    Time frame: Day 1am

  3. Serum ferritin

    Time frame: Day 1am

    Iron Status parameter

Secondary outcomes

  1. Hemoglobin

    Time frame: Day 1am

  2. Transferrin receptor

    Time frame: Day 1am

    Iron Status parameter

  3. c-reactive protein

    Time frame: Day 1am

    Inflammation parameter

  4. alpha-glycoprotein

    Time frame: Day 1am

    Inflammation parameter

  5. Saliva hepcidin

    Time frame: Day 1pm

    to assess variability in saliva hepcidin during the day

  6. Saliva hepcidin

    Time frame: Day 2am

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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2019
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.