NCT00811291

Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamine-B and Folic Acid Complex, calcium	90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids
DIETARY_SUPPLEMENT	calcium	according to protocol

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2011-12-01
• First posted: 2008-12-18
• Last updated: 2012-07-04

Locations

1 site across 1 country: Germany