跳至主要内容
临床试验/NCT00811291
NCT00811291已完成不适用

SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
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.

  1. 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.
  2. 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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Koletzko - Office

Professor Berthold Koletzko

Ludwig-Maximilians - University of Munich

研究点 (2)

Loading locations...

相似试验

Influence of Vitamin-B-complex on Cognitive Ability... | 临床试验