SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- change in outcome of cognitive testing of kindergarten kids after intervention
研究概览
简要总结
Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official recommendations. In studies with adults it has been found that for example providing people suffering from Alzheimer´s disease improved their mental and cognitive abilities when provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6 years of age, could also improve mentally from a recommended intake of B-vitamins and Folic Acid.
- screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of these vitamins, and the 250 kids with the lowest results will be invited for a randomized double blind intervention study.
- intervention study: Participating kids will get an one hour mental and cognitive testing before and after the intervention. The intervention will be one portion of the recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea, etc). The assumption is, that the treatment group will perform better than the placebo group in the second test phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 4-6 years
- •kindergarten kids in Munich
- •fluent in German
- •no medication
排除标准
- •not fluent in German
- •chronic illness
- •intake of multivitamin supplements
研究组 & 干预措施
1
干预措施: calcium (Dietary Supplement)
2
folic acid and B-vitamin supplement
干预措施: Vitamine-B and Folic Acid Complex, calcium (Dietary Supplement)
结局指标
主要结局
change in outcome of cognitive testing of kindergarten kids after intervention
时间窗: August 2009
次要结局
- Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method(September 2008-December 2008)
研究者
Koletzko - Office
Professor Berthold Koletzko
Ludwig-Maximilians - University of Munich
