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Completed

NCT Number: NCT00811291

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

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.

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Key information

Conditions

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. von Hauner Children´s Hospital

Munich, 80337, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamine-B and Folic Acid Complex, calcium

Dietary Supplement

90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids

Calcium

Dietary Supplement

according to protocol

Primary outcomes

  1. change in outcome of cognitive testing of kindergarten kids after intervention

    Time frame: August 2009

Secondary outcomes

  1. Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method

    Time frame: September 2008-December 2008

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • European Union
  • Unilever R&D

Registry information

Official study title

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

Acronym: SIMBA

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Dec 18, 2008
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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