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CompletedNCT00689949Updated Dec 24, 2012

Validation of Urinary Biomarkers of Folate Status

An interventional study of folic acid in Healthy, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-24.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • folic acid
  • folate
  • p-aminobenzoylglutamate
  • formiminoglutamate
  • homocysteine
  • experimental validation of a new biomarker
03

In context

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • recent (3 months) treatment with medication, assumed to interfere with folate status
  • abuse of alcohol or drugs
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Other
    folic acid

    Dietary Supplement: folic acid

Interventions

  • Dietary supplementfolic acid

    0.4 mg of folic acid per day

06

What researchers measure

Primary outcomes

  1. correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate

    Time frame: study day 1

Secondary outcomes

  1. correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate

    Time frame: study day 42

  2. correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate

    Time frame: study day 84

07

Study locations

1 site
  • Haunersche Kinderklinik
    Muenchen, D80337, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689949
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborators
European Union
First posted
Jun 4, 2008
Start date
Jun 2008
Primary completion
Oct 2008
Completion
Dec 2012
Last update
Dec 24, 2012

Study contacts

Berthold Koletzko, Prof. Dr.
principal investigator · Haunersche Kinderklinik, Ludwig-Maximilians-University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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