Validation of Urinary Biomarkers of Folate Status - Full Text View

Sponsors and Collaborators:	Ludwig-Maximilians - University of Munich European Union
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00689949

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

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Folic acid Homocysteine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Determination of the Suitability of Urinary Total p-Aminobenzoylglutamate and Formiminoglutamate as a Markers for Folate Status

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: basal and after 6 and 12 weeks of folic acid intake ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	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

Contacts

Contact: Johann Demmelmair, PhD

49 89 5160 ext 3692

Hans.Demmelmair@med.uni-muenchen.de

Locations

Germany
Haunersche Kinderklinik	Recruiting
Muenchen, Germany, D80337
Contact: Hans Demmelmair, PhD 49 89 5160 ext 3692 Hans.Demmelmair@med.uni-muenchen.de

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

European Union

Investigators

Principal Investigator:

Berthold Koletzko, Prof. Dr.

Haunersche Kinderklinik, Ludwig-Maximilians-University

More Information

Responsible Party:	Haunersche Kinderklinik, Ludwig-Maximilians-University ( Head of the Department for Nutrition and Metabolic Diseases )
Study ID Numbers:	144-08
Study First Received:	May 30, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00689949
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

Study placed in the following topic categories:

Folic Acid
Healthy

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009