Aluminium load in humans through food contact materials containing aluminium
Not Applicable
- Conditions
- Aluminium load and aluminium associated health threats
- Registration Number
- DRKS00026714
- Lead Sponsor
- Institut und Poliklinik für Arbeits-, Sozial- und Umweltmedizin der Friedrich-Alexander-Universität Erlangen-Nürnberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
serum creatinine and glomerular filtration rate within the norm;
basal aluminium excretion in urine within the reference range (< 15 µg/g creatinine)
Exclusion Criteria
persons unable to consent;
pregant/nursing women;
any personal restrictions regarding diet/food consumption (e.g. no vegan/vegetarian diet);
renal failure;
current or former dialysis;
specific immunotherapy with aluminium-containing depot-preparations within the last 5 years;
vacations with aluminium-containing vaccines within the last month;
use of aluminium-containing long-term medication within the last month;
oral intake of healing clay within the last month;
new tattoos within the last 12 months;
current or former occupation in the aluminium industry
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method repeated measurements of aluminium concentration in urine during diet with either no or respectively intensive contact to aluminium-containing food contact materials: <br>- for evaluation of a measurable additional aluminium burden in humans through utilisation of aluminium-containing food contact materials
- Secondary Outcome Measures
Name Time Method - one-time questionaire regarding personal characteristics (e.g. demography, smoking, etc.) and general contact to other potential aluminium sources<br><br>- daily food record during intervention