Determination of the Suitability of Urinary Total P-aminobenzoylglutamate (p-ABG)and Formiminoglutamate (FIGLU) as a Markers for Folate Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •recent (3 months) treatment with medication, assumed to interfere with folate status
- •abuse of alcohol or drugs
结局指标
主要结局
correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate
时间窗: study day 1
次要结局
- correlation between red blood cell folic acid concentration and urinary excretion of total p-aminobenzoylglutamate(study day 84)