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
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.
- 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.
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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
- change in outcome of cognitive testing of kindergarten kids after intervention [ Time Frame: August 2009 ]
- Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method [ Time Frame: September 2008-December 2008 ]
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
|Dr. von Hauner Children´s Hospital|
|Munich, Germany, 80337|
|Principal Investigator:||Berthold V Koletzko, M.D., PhD||Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich|