K50.0
Conditions
Interventions
Group 1: Healthy volunteers: single oral uptake of 45 mg titanium dioxide microparticles dispersed in 50 ml demineralized water and one week after single oral uptake of 45 mg titanium dioxide nanopart
Sponsors
Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers: All subjects should judge themselves as healthy and should not be under medication for at least 15 days before biomonitoring. In particular volunteers should not suffer from a chronic liver or renal disease that might influence metabolism and excretion of particles. Patients: clinical evidence for Crohn's disease with affection of small intestine, no comorbidities of liver and kidneys.
Exclusion criteria
Exclusion criteria: Individuals with anemia and pregnant women are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For determination of background levels urine is sampled 24 hours before oral intake of particles and a blood sample (7 ml) is taken. After ingestion of particles (micro/nano) blood samples (7 ml) are taken every 60 minutes over 9 hours and urine is sampled for another 24 hours. If silver particles were used a blood sample is also taken 24 hours after ingestion. Time course of intestinal particle absorption is measured by analyzing titanium or silver concentrations in blood and urine samples from healthy volunteers and patients with Crohn's disease. | — |
Countries
Germany
Contacts
Public ContactWolfgang Schober
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Outcome results
None listed