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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811291

Acronym

SIMBA

Enrollment

250

Registered

2008-12-18

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

B-vitamins, Folic-Acid, kindergarten kids, cognitive tests, Healthy kids, second part low urine vitamine-B-metabolites

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.

Interventions

DIETARY_SUPPLEMENTVitamine-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

DIETARY_SUPPLEMENTcalcium

according to protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

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

Design outcomes

Primary

Measure	Time frame
change in outcome of cognitive testing of kindergarten kids after intervention	August 2009

Secondary

Measure	Time frame
Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method	September 2008-December 2008

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026