B-vitamins Treatment for Improvement of Cognitive Function
Not Applicable
Completed
- Conditions
- Cognitive FunctionMetabolic Improvements
- Interventions
- Drug: B-vitamin complex
- Registration Number
- NCT01095211
- Lead Sponsor
- Universität des Saarlandes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo B-vitamin complex none of the vitamins (99.5% mannitol) B-Vitamins B-vitamin complex folic acid, cobalamin, vitamin B6
- Primary Outcome Measures
Name Time Method Cognitive function baseline and 45 days later
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dr. Eckert-
🇩🇪Sankt Ingbert, Saarland, Germany