Validation of Urinary Biomarkers of Folate Status
Validation of Urinary Biomarkers of Folate Status
NCT ID: NCT00689949 Phase: NA Status: COMPLETED Enrollment: 53 Completion: 2012-12
Conditions
Healthy
Interventions
folic acid
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 concentration, but can be obtained from spot urine samples. For this reason urine and blood will be collected from volunteers, twice at baseline and in a subgroup after 6 and 12 weeks of intake of a folic acid supplement
Specific hypotheses to be tested:
Correlation study:
- The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine concentration from the total p-ABG concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
- The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine concentration form the FIGLU concentration in a spot sample is significantly correlated to RBC and plasma folate levels in the studied subjects
Intervention study:
Changes in folate status (RBC folate) after supplementary intake of folate result in increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate status and in subjects identified with a high folate status among the study participants of the correlation study
Primary Outcome
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate