Optical iron deficiency diagnostics - evaluation of a fiber optic fluorescence measurement for the determination of zinc protoporphyrin in blood donors

Optical iron deficiency diagnostics - evaluation of a fiber optic fluorescence measurement for the determination of zinc protoporphyrin in blood donors - LFL_S4/2017

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013102

Enrollment

100

Registered

2017-09-29

Start date

2017-09-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E61.1 D50

Interventions

Group 1: A device is evaluated for the optical measurement of zinc protoporphyrin as an indicator of iron deficiency in blood donors. A fiberoptic probe delivers excitation light to the sample (lower

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Inclusion criteria

Inclusion criteria: Frequent blood donors (male and female) who are admitted to blood donation or who are rejected because of a too low Hb value. "Frequent blood donors" are persons who verifiably donated blood within the last 12 months at least 3 times (female) or 4 times (male). Written informed consent after informative discussion.

Exclusion criteria

Exclusion criteria: Blood donors who are rejected from blood donation because of other reasons than a low Hb value. Transfusion of blood products within the last 12 months. Known iron supplementation (on-going or finished within the last 3 months). Known hemochromatosis.

Design outcomes

Primary

Measure	Time frame
Evaluation of the applicability of the measurement procedure at the blood donation tube (questionnaire in the CRF and statistical evaluation of raw data) and stability of the measured zinc protoporphyrin values (repetitive measurements).	—

Secondary

Measure	Time frame
Comparison of the measurements on the blood donation tube and of the non-invasive measurements on the lower lip with the measurement on whole blood. In addition, other blood parameters of iron metabolism are determined from an available blood sample (i.a. Hb, MCV, Hct, ferritin, transferrin, transferrin saturation, CRP, soluble transferrin receptor) and correlated with the measurements of zinc protoporphyrin. About 6 months after recruitment of the participant, latest 6 months after recruitment of the last participant, the principal investigator or deligate evaluates, if the respective participant has donated blood during these 6 months and which hemoglobin value was measured.	—

Measure

Time frame

Comparison of the measurements on the blood donation tube and of the non-invasive measurements on the lower lip with the measurement on whole blood. In addition, other blood parameters of iron metabolism are determined from an available blood sample (i.a. Hb, MCV, Hct, ferritin, transferrin, transferrin saturation, CRP, soluble transferrin receptor) and correlated with the measurements of zinc protoporphyrin. About 6 months after recruitment of the participant, latest 6 months after recruitment of the last participant, the principal investigator or deligate evaluates, if the respective participant has donated blood during these 6 months and which hemoglobin value was measured.

—

Countries

Germany

Contacts

Public ContactHerbert Stepp

Laser-ForschungslaborLIFE-ZentrumKlinikum der Universität München

herbert.stepp@med.uni-muenchen.de+49 89 4400 74880

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026