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Validation of Urinary Biomarkers of Folate Status

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00689949
First received: May 30, 2008
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: folic acid

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate [ Time Frame: study day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate [ Time Frame: study day 42 ] [ Designated as safety issue: No ]
  • correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate [ Time Frame: study day 84 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
folic acid Dietary Supplement: folic acid
0.4 mg of folic acid per day

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689949

Locations
Germany
Haunersche Kinderklinik
Muenchen, Germany, D80337
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
European Union
Investigators
Principal Investigator: Berthold Koletzko, Prof. Dr. Haunersche Kinderklinik, Ludwig-Maximilians-University
  More Information

No publications provided

Responsible Party: Head of the Department for Nutrition and Metabolic Diseases, Haunersche Kinderklinik, Ludwig-Maximilians-University
ClinicalTrials.gov Identifier: NCT00689949     History of Changes
Other Study ID Numbers: 144-08
Study First Received: May 30, 2008
Last Updated: December 21, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
folic acid
folate
p-aminobenzoylglutamate
 formiminoglutamate
homocysteine
experimental validation of a new biomarker

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013