NCT00811291

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

December 17, 2008

Last Update Submit

July 3, 2012

Conditions

Healthy

Keywords

B-vitaminsFolic-Acidkindergarten kidscognitive testsHealthy kidssecond part low urine vitamine-B-metabolites

Outcome Measures

Primary Outcomes (1)

  • change in outcome of cognitive testing of kindergarten kids after intervention

    August 2009

Secondary Outcomes (1)

  • Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method

    September 2008-December 2008

Study Arms (2)

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

Vitamine-B and Folic Acid Complex, calciumDIETARY_SUPPLEMENT

90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids

2
calciumDIETARY_SUPPLEMENT

according to protocol

1

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age: 4-6 years
  • kindergarten kids in Munich
  • fluent in German
  • healthy
  • no medication

You may not qualify if:

  • not fluent in German
  • chronic illness
  • intake of multivitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. von Hauner Children´s Hospital

Munich, 80337, Germany

Location

MeSH Terms

Interventions

Calcium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Berthold V Koletzko, M.D., PhD

    Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Berthold Koletzko

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2011

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

DE(1)