Validation of Urinary Biomarkers of Folate Status

NCT00689949 | Completed

• 1 other identifier: 144-08
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  study day 1

Secondary Outcomes (2)

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

  study day 42

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

  study day 84

Study Arms (1)

folic acid

OTHER

Dietary Supplement: folic acid

Interventions

folic acid DIETARY_SUPPLEMENT

0.4 mg of folic acid per day

folic acid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• European Union: collaborator

Study Sites (1)

Haunersche Kinderklinik

München, D80337, Germany

Location

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Berthold Koletzko, Prof. Dr.

  Haunersche Kinderklinik, Ludwig-Maximilians-University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 4, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

DE (1)