Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2008-06-30
2012-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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folic acid
folic acid
0.4 mg of folic acid per day
Interventions
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folic acid
0.4 mg of folic acid per day
Eligibility Criteria
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Inclusion Criteria
* 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
* abuse of alcohol or drugs
18 Years
45 Years
MALE
Yes
Sponsors
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European Union
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Haunersche Kinderklinik, Ludwig-Maximilians-University
Principal Investigators
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Berthold Koletzko, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Haunersche Kinderklinik, Ludwig-Maximilians-University
Locations
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Haunersche Kinderklinik
München, , Germany
Countries
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Other Identifiers
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144-08
Identifier Type: -
Identifier Source: org_study_id