Cognitive Function, Metabolic Improvements
Conditions
Keywords
folic acid, homocysteine, MMSE scores, methyl malonic acid, betaine
Brief summary
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.
Detailed description
We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.
Interventions
DRUGB-vitamin complex
5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily
Sponsors
Geriatrische Rehaklinik
Universität des Saarlandes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 65 years and glomerular filtration rate (GFR) \> 35 ml/min
Exclusion criteria
* acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study. * furthermore, people who had dementia (mini-mental state-examination scores MMSE \< 15) * those treated with B-vitamins * those with renal insufficiency * those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function | baseline and 45 days later |
Countries
Germany
Outcome results
None listed