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Completed

NCT Number: NCT00689949

Validation of Urinary Biomarkers of Folate Status

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Haunersche Kinderklinik

München, D80337, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Dietary Supplement

0.4 mg of folic acid per day

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • European Union

Registry information

Official study title

Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status

Important dates

Study start
2008
Primary completion
2008
Study completion
2012
First posted
Jun 4, 2008
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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