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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: calcium; Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium

• Registration Number: NCT00811291
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2009-08
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• age: 4-6 years
• kindergarten kids in Munich
• fluent in German
• healthy
• no medication

Exclusion Criteria

• not fluent in German
• chronic illness
• intake of multivitamin supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	calcium	-
2	Vitamine-B and Folic Acid Complex, calcium	folic acid and B-vitamin supplement

Primary Outcome Measures

Name	Time	Method
change in outcome of cognitive testing of kindergarten kids after intervention	August 2009

Secondary Outcome Measures

Name	Time	Method
Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method	September 2008-December 2008

Trial Locations

Locations (1)

Dr. von Hauner Children´s Hospital; 🇩🇪 Munich, Germany