Validation of Urinary Biomarkers of Folate Status

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00689949

144-08

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

folic acid

Other group

Treatment:

Dietary Supplement: folic acid