Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids (SIMBA)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: calcium; Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00811291

08032V

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

250 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Dietary Supplement: calcium

2

Active Comparator group

Description:

folic acid and B-vitamin supplement

Treatment:

Dietary Supplement: Vitamine-B and Folic Acid Complex, calcium