Clinical trial NCT00689949: Validation of Urinary Biomarkers of Folate Status
Official title: Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: folic acid
folate
p-aminobenzoylglutamate
formiminoglutamate
homocysteine
experimental validation of a new biomarker
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2008-06-04
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* recent (3 months) treatment with medication, assumed to interfere with folate status
* abuse of alcohol or drugs

Primary outcomes:
measure: correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
timeFrame: study day 1
Secondary outcomes:
measure: correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
timeFrame: study day 42
measure: correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
timeFrame: study day 84
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Haunersche Kinderklinik
Study officials:
affiliation: Haunersche Kinderklinik, Ludwig-Maximilians-University
name: Berthold Koletzko, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: