NCT02310607

Brief Summary

This study aims to evaluate a prototype device detecting zinc protoporphyrin-IX fluorescence non-invasively from the intact oral mucosa. Zinc protoporphyrin-IX is an established indicator of iron deficiency. The prototype device is used to measure the erythrocyte zinc protoporphyrin-IX/heme ratio for women after delivery, a study group chosen because of an elevated risk of iron deficiency. The results from the non-invasive measurements are compared to reference measurements of the erythrocyte zinc protoporphyrin-IX/heme ratio from residual blood samples from the same patients and to other indicators of iron status, including hemoglobin, ferritin, serum iron, transferrin, transferrin saturation and soluble transferrin receptor. Funding Source - Nestec Ltd.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

December 2, 2014

Last Update Submit

April 7, 2015

Conditions

Anemia, Iron-Deficiency

Keywords

Post-partum women

Outcome Measures

Primary Outcomes (1)

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with HPLC reference (Spearman's Rho correlation, sensitivity and specificity)

    Erythrocyte zinc protoporphyrin IX in the units of μmol/mol heme, as determined from non-invasive fluorescence and remission spectroscopic measurements at the oral mucosa, compared with reference standard determinations of erythrocyte zinc protoporphyrin IX in blood samples by high performance liquid chromatography (HPLC).

    1 day after measurement

Secondary Outcomes (1)

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with estimate of body iron (sensitivity and specificity)

    1 day after measurement

Other Outcomes (7)

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hematofluorometer (Spearman's Rho correlation, sensitivity, specificity)

    1 day after measurement

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with hemoglobin (sensitivity and specificity)

    1 day after measurement

  • Comparison of non-invasive erythrocyte zinc protoporphyrin IX measurements with ferritin (sensitivity and specificity)

    1 day after measurement

  • +4 more other outcomes

Interventions

Not an interventional studyOTHER

Not an interventional study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women post-partum

You may qualify if:

  • Women after delivery of term infants
  • Pregnancy and delivery without study-relevant complications
  • Hb value pre-partum greater or equal 12 g/dL or less or equal 11 g/dL
  • Regular blood withdrawal before and after delivery for clinical indications
  • Informed consent to participation in the study
  • Age 18 or older

You may not qualify if:

  • Patients who are not legally competent
  • Transfusion of blood products in the course of delivery
  • Thalassemia and sickle cell anemia
  • Any acute or chronic infectious or inflammatory disease
  • Insufficient amount of residual blood in the clinically indicated post partum sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Klinikum der Universitaet Muenchen, Grosshadern

Munich, D-81377, Germany

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Uwe Hasbargen, PD Dr. med.

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 8, 2014

Study Start

June 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

DE(1)