Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids (SIMBA)

This study has been completed.
European Union
Unilever R&D
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich Identifier:
First received: December 17, 2008
Last updated: July 3, 2012
Last verified: July 2012

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.

Condition Intervention
Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium
Dietary Supplement: calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • change in outcome of cognitive testing of kindergarten kids after intervention [ Time Frame: August 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method [ Time Frame: September 2008-December 2008 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Dietary Supplement: calcium
according to protocol
Active Comparator: 2
folic acid and B-vitamin supplement
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


Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00811291

Dr. von Hauner Children´s Hospital
Munich, Germany, 80337
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
European Union
Unilever R&D
Principal Investigator: Berthold V Koletzko, M.D., PhD Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich
  More Information

No publications provided

Responsible Party: Koletzko - Office, Professor Berthold Koletzko, Ludwig-Maximilians - University of Munich Identifier: NCT00811291     History of Changes
Other Study ID Numbers: 08032V
Study First Received: December 17, 2008
Last Updated: July 3, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
kindergarten kids
cognitive tests
Healthy kids
second part low urine vitamine-B-metabolites

Additional relevant MeSH terms:
Calcium, Dietary
Folic Acid
Vitamin B Complex
Vitamin E
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Growth Substances
Hematologic Agents
Therapeutic Uses
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on April 16, 2014