Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- blood metabolic markers
研究概览
简要总结
The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.
详细描述
The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Age > 65 years.
排除标准
- •Renal dysfunction
- •Recent stroke, or coronary event (within the last 3 months)
- •Current cancer treatment
- •Antifolate (e.g. methotrexate) treatment
- •Ileum resection
- •Current B-vitamin supplement
- •Epilepsy medications
- •Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.
研究组 & 干预措施
folic acid plus B6 and B12
folic 400 µg plus vitamin B12 plus B6
干预措施: folic acid plus B6 and B12 (Dietary Supplement)
Folic acid
folic acid alone
干预措施: folic acid (Dietary Supplement)
结局指标
主要结局
blood metabolic markers
时间窗: 18 months
we will measure primary folate forms after folic acid supplement
次要结局
未报告次要终点
研究者
Rima Obeid
Prof. Dr.
Universität des Saarlandes