Status:
COMPLETED
Validation of Urinary Biomarkers of Folate Status
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
European Union
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
The major objective of the proposed study is to demonstrate the suitability of new markers for folate status in humans, which avoid blood sampling, as required for the established marker RBC folate co...
Eligibility Criteria
Inclusion
- age: 18 - 45 years
- apparently healthy
- normal results on haematologic pattern and blood chemistry tests (according to university hospital reference values)
- plasma vitamin B12 \> 160 pmol/l
- no diagnosis of intestinal, renal or thyroid disease (self reported)
- only male subjects will be enrolled but regular consumption of vitamin supplements (including folate) is not an exclusion criterium, as we aim to cover a wide range of folate concentrations.
Exclusion
- recent (3 months) treatment with medication, assumed to interfere with folate status
- abuse of alcohol or drugs
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00689949
Start Date
June 1 2008
End Date
December 1 2012
Last Update
December 24 2012
Active Locations (1)
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1
Haunersche Kinderklinik
München, Germany, D80337