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

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ClinicalTrials.gov Identifier: NCT00811291
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : July 4, 2012
Sponsor:
Collaborators:
European Union
Unilever R&D
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium Dietary Supplement: calcium Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in outcome of cognitive testing of kindergarten kids after intervention [ Time Frame: August 2009 ]

Secondary Outcome Measures :
  1. Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method [ Time Frame: September 2008-December 2008 ]


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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Koletzko - Office, Professor Berthold Koletzko, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00811291     History of Changes
Other Study ID Numbers: 08032V
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by Koletzko - Office, 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:
Vitamins
Folic Acid
Calcium, Dietary
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics