- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00689949
Validation of Urinary Biomarkers of Folate Status
Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for 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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Muenchen, Germany, D80337
- Haunersche Kinderklinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: folic acid
|
0.4 mg of folic acid per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time Frame: study day 1
|
study day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time Frame: study day 42
|
study day 42
|
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
Time Frame: study day 84
|
study day 84
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Berthold Koletzko, Prof. Dr., Haunersche Kinderklinik, Ludwig-Maximilians-University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 144-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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