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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium
* Dietary Supplement: calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: calcium<br>* according to protocol<br>|
| Active Comparator: 2<br>folic acid and B-vitamin supplement | Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium<br>* 90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in outcome of cognitive testing of kindergarten kids after intervention |  | August 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method |  | September 2008-December 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-vitamins, Folic-Acid, kindergarten kids, cognitive tests, Healthy kids, second part low urine vitamine-B-metabolites