Assessment of Functional Vitamin B12 Deficiency in Mexican Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
研究概览
简要总结
We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity. However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin. This information will help decide weather supplementation with vitamin B12 is necessary in such populations for public health reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 20-59, apparently healthy, no severe B12 deficiency
排除标准
- •pregnancy, lactation, anemia and disease states
结局指标
主要结局
response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations
时间窗: 0 and 3 mos
次要结局
- DNA methylation change, and hematological response to B12 supplementation(0 and 3 mos)