- Validation of the distribution of DBDE in human blood - Screening of 4 different European countries on DBDE in human blood - to collect human blood samples over a period of ten years from 80 subjects over a 10 year period to establish a long term…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
endocrine disruption
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DecaDBE in human blood
Secondary outcome
none
Background summary
There is lack of reliable data on the levels of DBDE in humans. DBDE is used in
plastic materials and in textiles. It is not known whether humans are mainly
exposed to DBDE through this route or via the food chain. The bromine industry
is reducing the use of DBDE and therefore it is interesting to establish the
long term trend in DBDE levels in human blood
Study objective
- Validation of the distribution of DBDE in human blood
- Screening of 4 different European countries on DBDE in human blood
- to collect human blood samples over a period of ten years from 80 subjects
over a 10 year period to establish a long term trend
- to investigate effect of lifestyle and environment on DBDE concentrations in
blood
- to perform a human risk assessment for DBDE based on the concentrations in
blood in this project, combined with results in other ongoing research projects
Study design
Subjects will be visited in a convenient place (work area or home) and in each
visit they will have to complete a short questionnaire and 80mls of their blood
is drawn. After a pilot study in 10 participants, 40 subjects from 4 European
countries will complete the questionnaire and donate 80mls of blood. Three to
six months after the first visit a second follows, to document personal
variation in DBDE levels.
The country that has the highest levels of DBDE will participate in the years
3, 5, 7 and 9. In each of those years a group of 40 new subjects and 40 from
the previous study period will participate.
Study burden and risks
Participation consists out of completing a questionnaire and a blood donation,
this takes 30 minutes. For each participant this will happen at most 4 times in
a 2.5 year period. Participants will be visited in a convenient place, and
therefore the burden of participation is small.
118 Av. De Cortenbergh
1000 Brussles
Belgie
118 Av. De Cortenbergh
1000 Brussles
Belgie
Listed location countries
Age
Inclusion criteria
female 20-40 yr old
Exclusion criteria
occupational exposure to DBDE
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13197.041.06 |