HealthySIMBANCT00811291
Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids
A study testing Vitamine-B and Folic Acid Complex, calcium and calcium in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamine-B and Folic Acid Complex, calcium and calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age: 4-6 years
- kindergarten kids in Munich
- fluent in German
- healthy
- no medication
Who cannot join
- not fluent in German
- chronic illness
- intake of multivitamin supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children
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.
- Conditions
- Healthy
- Being tested
- Vitamine-B and Folic Acid Complex, calcium, calcium
- Keywords
- B-vitamins, Folic-Acid, kindergarten kids, cognitive tests, Healthy kids, second part low urine vitamine-B-metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
calciumDietary supplement
according to protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: calcium |
| 2 | Active comparator | folic acid and B-vitamin supplement Receives: Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in outcome of cognitive testing of kindergarten kids after intervention
Measured: August 2009
Secondary outcomes (1)
Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method
Measured: September 2008-December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Unilever R&D
- Responsible party
- Principal investigator, Koletzko - Office, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold V Koletzko, M.D., PhD, Principal investigator, Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811291
- Sponsor's protocol ID
- 08032V
- Acronym
- SIMBA
- Status last verified
- Jul 2012
- First submitted
- 17 Dec 2008
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children
- ClinicalTrials.gov ID
- NCT00811291
- Acronym / sponsor ID
- SIMBA / 08032V
- Conditions
- Healthy
- Keywords
- B-vitamins, Folic-Acid, kindergarten kids, cognitive tests, Healthy kids, second part low urine vitamine-B-metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- European Union, Unilever R&D
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: calcium |
| 2 | Active comparator | Dietary Supplement: Vitamine-B and Folic Acid Complex, calciumfolic acid and B-vitamin supplement |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age: 4-6 years
- kindergarten kids in Munich
- fluent in German
- healthy
- no medication
Key exclusion criteria (3 listed)
- not fluent in German
- chronic illness
- intake of multivitamin supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamine-B and Folic Acid Complex, calcium90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids | Dietary supplement | 2 |
| calciumaccording to protocol | Dietary supplement | 1 |
Primary outcome
change in outcome of cognitive testing of kindergarten kids after intervention
Time frame: August 2009
1 secondary outcome
Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method
Time frame: September 2008-December 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold V Koletzko, M.D., PhD principal investigator
Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamine-B and Folic Acid Complex, calcium and calcium in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in outcome of cognitive testing of kindergarten kids after intervention (time frame: August 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.