Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids
NCT ID: NCT00811291
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2008-09-30
2011-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
calcium
according to protocol
2
folic acid and B-vitamin 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
Interventions
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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
calcium
according to protocol
Eligibility Criteria
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Inclusion Criteria
* kindergarten kids in Munich
* fluent in German
* healthy
* no medication
Exclusion Criteria
* chronic illness
* intake of multivitamin supplements
4 Years
6 Years
ALL
Yes
Sponsors
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European Union
OTHER
Unilever R&D
INDUSTRY
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Koletzko - Office
Professor Berthold Koletzko
Principal Investigators
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Berthold V Koletzko, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich
Locations
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Dr. von Hauner Children´s Hospital
Munich, , Germany
Countries
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Other Identifiers
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08032V
Identifier Type: -
Identifier Source: org_study_id