Influence of Vitamin-B-complex on Cognitive Ability of Ki... | NCT00811291

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

NCT00811291

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Jul 4, 2012Estimated

Enrollment

250Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Vitamine-B and Folic Acid Complex, calcium
calcium

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2012

Last Update Posted Date

Jul 4, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Koletzko - Office, Professor Berthold Koletzko, Ludwig-Maximilians - University of MunichPrincipal Investigator

Lead Sponsor

Ludwig-Maximilians - University of MunichOTHER

Collaborators

Name	Class
European Union	OTHER
Unilever R&D	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Dietary Supplement: calcium
2	Active Comparator	folic acid and B-vitamin supplement	Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamine-B and Folic Acid Complex, calcium	Dietary Supplement	90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Berthold V Koletzko, M.D., PhD	Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. von Hauner Children´s Hospital		Munich		80337	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D002118	Calcium

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals

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