B-vitamins Treatment for Improvement of Cognitive Function

Universität des Saarlandes

Status: Completed

Conditions: Cognitive Function; Metabolic Improvements

Treatments: Drug: B-vitamin complex

Study type: Interventional

Funder types: Other

Identifiers

NCT01095211

Elderly St.Ingbert

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

B-Vitamins

Active Comparator group

Description:

folic acid, cobalamin, vitamin B6

Treatment:

Drug: B-vitamin complex

placebo

Placebo Comparator group

Description:

none of the vitamins (99.5% mannitol)

Treatment:

Drug: B-vitamin complex