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

This study has been completed.
Sponsor:
Collaborators:
European Union
Unilever R&D
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00811291
First received: December 17, 2008
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Healthy
 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:

U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00811291

Locations
Germany
Dr. von Hauner Children´s Hospital
Munich, Germany, 80337
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
European Union
Unilever R&D
Investigators
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
ClinicalTrials.gov 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:
B-vitamins
Folic-Acid
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
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 13, 2013