The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- serum B12 status
研究概览
简要总结
In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.
详细描述
During a 12 week period subjects will consume
- bread fortified with folic acid and vitamin B12 or
- placebo bread (not fortified)
Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.
We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 50-75y
排除标准
- •consumption of < 3 slices of bread/day
- •use of B-vitamins in the period three months prior to the study
- •treatment with B12-injections in the last 5y
- •illness or use of medication interfering with folate or vitamin B12 metabolism
结局指标
主要结局
serum B12 status
serum folate status
次要结局
- erythrocyte folate;
- homocysteine;
- MMA;
- holoTC